Page last updated: 2024-10-17

salicylic acid and Keratosis, Actinic

salicylic acid has been researched along with Keratosis, Actinic in 110 studies

Scalp: The outer covering of the calvaria. It is composed of several layers: SKIN; subcutaneous connective tissue; the occipitofrontal muscle which includes the tendinous galea aponeurotica; loose connective tissue; and the pericranium (the PERIOSTEUM of the SKULL).

Keratosis, Actinic: White or pink lesions on the arms, hands, face, or scalp that arise from sun-induced DNA DAMAGE to KERATINOCYTES in exposed areas. They are considered precursor lesions to superficial SQUAMOUS CELL CARCINOMA.

Research Excerpts

ExcerptRelevanceReference
"5%/salicylic acid 10% (5-FU/SA) topical solution has been included in the National Italian portfolio for lesion-directed treatment of grade I/II actinic keratosis (AKs) located on the face or scalp."7.96Treatment monitoring of 5-fluorouracil 0.5%/salicylic acid 10% lesion-directed therapy for actinic keratosis using dermoscopy and in-vivo reflectance confocal microscopy. ( Benati, E; Condorelli, A; Cornacchia, L; Guiducci, L; Lai, M; Longo, C; Mirra, M; Pampena, R; Pellacani, G; Peris, K; Raucci, M, 2020)
"5%/salicylic acid 10% (5-FU/SA) in the treatment of isolated hyperkeratotic actinic keratosis lesions in Spain."7.81Cost-effectiveness analysis of 5-fluorouracil 0.5%/salicylic acid 10% in the treatment of actinic keratosis in Spain. ( Brosa, M; Ferrándiz, C; Nieves, D; Plazas, MJ; Puig-Peiró, R, 2015)
"Photodynamic therapy with 5-methyl-aminolevulinate and photodynamic therapy with trichloroacetic acid 50% are the two techniques utilized in the management of actinic keratosis."7.81Comparative study of trichloroacetic acid vs. photodynamic therapy with topical 5-aminolevulinic acid for actinic keratosis of the scalp. ( Boccaletti, V; Conti, ML; Cortelazzi, C; Di Nuzzo, S; Fabrizi, G; Feliciani, C; Montanari, P; Pagliarello, C; Zucchi, A, 2015)
"Both imiquimod and MAL-PDT were effective in the reduction in the number of AK."7.01Comparative study of imiquimod 3.75% vs. photodynamic therapy for actinic keratosis of the scalp. ( Castagnetti, E; Cortelazzi, C; Di Nuzzo, S; Odorici, G; Pellacani, G, 2021)
"At 6-month posttreatment follow-up, recurrence of cleared lesions (no clinically visible lesions in treatment area) occurred in 39."6.80A prospective randomized exploratory study comparing the efficacy of once-daily topical 0.5% 5-fluorouracil in combination with 10.0% salicylic acid (5-FU/SA) vs. cryosurgery for the treatment of hyperkeratotic actinic keratosis. ( Dirschka, T; Dominicus, R; Karl, L; Rodríguez, R; Simon, JC; Willers, C, 2015)
"Imiquimod 3."5.43Efficacy and Safety of Imiquimod 3.75% from Lmax in Actinic Keratosis According to Fitzpatrick Skin Type. ( Alomar, A; Aractingi, S; Dakovic, R; Dirschka, T; Gupta, G; Peris, K; Stockfleth, E, 2016)
" Protoporphyrin IX (PpIX) accumulation becomes lower after 3 h in pulse-PDT than in classical PDT, but pulse-PDT still has full treatment effect on actinic keratosis (AK)."5.27Protoporphyrin IX formation after application of methyl aminolevulinate on the face and scalp with and without prior curettage. ( Bieliauskiene, G; Heerfordt, IM; Wulf, HC, 2018)
"Topical 5-aminolevulinic acid (ALA) photodynamic therapy (PDT) is an effective treatment for actinic keratosis (AK) with some transient adverse events."5.19Topical photodynamic therapy of actinic keratoses with 5-aminolevulinic acid: randomized controlled trial with six months follow-up. ( Buinauskaite, E; Buinauskiene, J; Maciulaitis, R; Valiukeviciene, S, 2014)
" The articles were selected following a MEDLINE database search of the combined terms fluorouracil, salicylic acid and actinic keratosis which represent the peer review publications of clinical studies that primarily investigate the use of Actikerall in AK."4.93Low-Dose 0.5% 5-Fluorouracil/10% Salicylic Acid Topical Solution in the Treatment of Actinic Keratoses. ( Azeredo, RR; Dirschka, T; Herranz, P; Morton, C; Roldán-Marín, R, 2016)
"5%/salicylic acid 10% (5-FU/SA) topical solution has been included in the National Italian portfolio for lesion-directed treatment of grade I/II actinic keratosis (AKs) located on the face or scalp."3.96Treatment monitoring of 5-fluorouracil 0.5%/salicylic acid 10% lesion-directed therapy for actinic keratosis using dermoscopy and in-vivo reflectance confocal microscopy. ( Benati, E; Condorelli, A; Cornacchia, L; Guiducci, L; Lai, M; Longo, C; Mirra, M; Pampena, R; Pellacani, G; Peris, K; Raucci, M, 2020)
"To non-invasively assess the pharmacodynamic changes induced by treatment with low dose 5-fluorouracil and 10% salicylic acid by means of RCM and high-definition OCT in field cancerization and actinic keratosis."3.83Treatment monitoring of 0.5% 5-fluorouracil and 10% salicylic acid in clinical and subclinical actinic keratoses with the combination of optical coherence tomography and reflectance confocal microscopy. ( Alarcon, I; Malvehy, J; Montoya, J; Puig, S; Rodríguez-Azeredo, R, 2016)
"5%/salicylic acid 10% (5-FU/SA) in the treatment of isolated hyperkeratotic actinic keratosis lesions in Spain."3.81Cost-effectiveness analysis of 5-fluorouracil 0.5%/salicylic acid 10% in the treatment of actinic keratosis in Spain. ( Brosa, M; Ferrándiz, C; Nieves, D; Plazas, MJ; Puig-Peiró, R, 2015)
"Photodynamic therapy with 5-methyl-aminolevulinate and photodynamic therapy with trichloroacetic acid 50% are the two techniques utilized in the management of actinic keratosis."3.81Comparative study of trichloroacetic acid vs. photodynamic therapy with topical 5-aminolevulinic acid for actinic keratosis of the scalp. ( Boccaletti, V; Conti, ML; Cortelazzi, C; Di Nuzzo, S; Fabrizi, G; Feliciani, C; Montanari, P; Pagliarello, C; Zucchi, A, 2015)
"Pain is a frequent adverse event during photodynamic therapy, which can limit treatment acceptance."3.11Randomized controlled trial for evaluation of efficacy and pain during photodynamic therapy for actinic keratosis of face and scalp comparing two irradiation protocols. ( Ag, S; Er, O; Ha, M; Lpf, A; Mb, R; Mmc, M; Mr, G, 2022)
"Pretreatment with diclofenac for four weeks improved the clearance rate in one study (24."3.01Improving the efficacy of photodynamic therapy for actinic keratosis: A comprehensive review of pharmacological pretreatment strategies. ( Andersen, F; Bjerring, P; Haedersdal, M; Lerche, CM; Pihl, C, 2023)
"Both imiquimod and MAL-PDT were effective in the reduction in the number of AK."3.01Comparative study of imiquimod 3.75% vs. photodynamic therapy for actinic keratosis of the scalp. ( Castagnetti, E; Cortelazzi, C; Di Nuzzo, S; Odorici, G; Pellacani, G, 2021)
"Pain was significantly higher during the second session (p = 0."2.90Single versus two-treatment schedule of methyl aminolevulinate daylight photodynamic therapy for actinic keratosis of the face and scalp: An intra-patient randomized trial. ( Fargnoli, MC; Gutiérrez García-Rodrigo, C; Pellegrini, C; Piccioni, A; Tambone, S, 2019)
" Adverse events were predominantly mild or moderate."2.84Safety and Efficacy of Escalating Doses of Ingenol Mebutate for Field Treatment of Actinic Keratosis on the Full Face, Full Balding Scalp, or Chest. ( Berman, B; Bukhalo, M; Hanke, CW; Pariser, DM; Siegel, D; Skov, T; Swanson, N; Villumsen, J; Weiss, JS, 2017)
"At 6-month posttreatment follow-up, recurrence of cleared lesions (no clinically visible lesions in treatment area) occurred in 39."2.80A prospective randomized exploratory study comparing the efficacy of once-daily topical 0.5% 5-fluorouracil in combination with 10.0% salicylic acid (5-FU/SA) vs. cryosurgery for the treatment of hyperkeratotic actinic keratosis. ( Dirschka, T; Dominicus, R; Karl, L; Rodríguez, R; Simon, JC; Willers, C, 2015)
"However, pain is a major side-effect of this therapy."2.80Comparing cold-air analgesia, systemically administered analgesia and scalp nerve blocks for pain management during photodynamic therapy for actinic keratosis of the scalp presenting as field cancerization: a randomized controlled trial. ( Graf, B; Gruber, M; Hansen, E; Heinlin, J; Horner, C; Karrer, S; Kerscher, C; Klein, A; Koller, M; Landthaler, M; Szeimies, RM; Werner, A; Zeman, F, 2015)
"Cryosurgery is the most common treatment for actinic keratosis (AK) in the United States."2.79Efficacy and safety of ingenol mebutate 0.015% gel 3 weeks after cryosurgery of actinic keratosis: 11-week results. ( Berman, B; Goldenberg, G; Goncalves, J; Hanke, CW; Knudsen, KM; Larsson, T; Skov, T; Swanson, N; Tyring, SK; Werschler, WP, 2014)
"Imiquimod 3."2.75Pharmacokinetics of imiquimod 3.75% cream applied daily for 3 weeks to actinic keratoses on the face and/or balding scalp. ( Adams, M; Fein, MC; Furst, J; Kulp, J; Levy, S; Meng, TC, 2010)
"imiquimod 3."2.47Imiquimod 3.75% cream (Zyclara) for the treatment of actinic keratoses. ( Gollnick, HP; Quist, SR, 2011)
"Actinic keratosis have a high risk of progression to a squamous cell carcinoma."1.91IGF1 synthesis after CO ( Cartocci, A; Cinotti, E; Fiorani, D; Rubegni, P; Trovato, E, 2023)
" In the future, further studies are needed to evaluate the chance of adjusting drug dosage according to patients' and actinic keratoses features."1.72Early clinical response to 5-fluorouracil 0.5% and salicylic acid 10% topical solution in the treatment of actinic keratoses of the head: an observational study. ( Bianchi, L; Campione, E; Cosio, T; Di Prete, M; Di Raimondo, C; Diluvio, L; Gaeta Shumak, R; Garofalo, V; Geraci, F; Lambiase, S; Lanna, C; Lozzi, F, 2022)
" This prospective open-label observational single-arm study examined efficacy and safety of simulated daylight (SDL)-PDT using the IndoorLux® system in combination with 5-aminolevulinic acid gel (BF-200 ALA)."1.72No room for pain: A prospective study showing effective and nearly pain-free treatment of actinic keratosis with simulated daylight photodynamic therapy (SDL-PDT) using the IndoorLux® System in combination with BF-200 ALA (Ameluz®). ( Bai-Habelski, JC; Medrano, K; Palacio, A; Reinhold, U, 2022)
" Patient satisfaction was evaluated by questionnaire, and adverse effects were documented."1.72Efficacy and safety of a thermal fractional skin rejuvenation system (Tixel) for the treatment of facial and/or scalp actinic keratoses. ( Agmon, Y; Chorny, I; Friedland, R; Hodak, E; Klein, I; Lapidoth, M; Leshem, YA; Levi, A; Mimouni, D; Oren-Shabtai, M; Sloutsky, N; Snast, I, 2022)
"5% 5-fluorouracil solution in combination with 10% salicylic acid (low-dose 5-FU/SA) are mostly related to lesions appearing on the head and face."1.46Low-dose 5-fluorouracil in combination with salicylic acid for the treatment of actinic keratoses on the hands and/or forearms - results of a non-interventional study. ( Hadshiew, I; Melzer, A; Prechtl, A; Reinhold, U, 2017)
"Scalp melanoma has a worse prognosis than melanoma elsewhere, though the reasons for this are poorly understood."1.46Scalp melanoma: Distinctive high risk clinical and histological features. ( Kelly, JW; Mar, V; McLean, C; Pan, Y; Wolfe, R; Xie, C, 2017)
"Imiquimod 3."1.43Efficacy and Safety of Imiquimod 3.75% from Lmax in Actinic Keratosis According to Fitzpatrick Skin Type. ( Alomar, A; Aractingi, S; Dakovic, R; Dirschka, T; Gupta, G; Peris, K; Stockfleth, E, 2016)
"Patients suffering from chronic lymphocytic leukemia often develop actinic keratosis (AK) and squamous cell carcinoma in sun-exposed areas."1.43Ingenol Mebutate 500 μg for Treatment of the Scalp in Refractory Field Cancerization. ( Clayton, H; Gaide, O; Girardin, M; Kuonen, F, 2016)

Research

Studies (110)

TimeframeStudies, this research(%)All Research%
pre-19903 (2.73)18.7374
1990's0 (0.00)18.2507
2000's2 (1.82)29.6817
2010's80 (72.73)24.3611
2020's25 (22.73)2.80

Authors

AuthorsStudies
Garofalo, V1
Geraci, F1
Di Prete, M1
Lanna, C1
Lozzi, F1
Cosio, T1
Lambiase, S1
Gaeta Shumak, R1
Di Raimondo, C1
Diluvio, L2
Bianchi, L1
Campione, E2
Pihl, C1
Lerche, CM1
Andersen, F1
Bjerring, P1
Haedersdal, M2
Pampena, R1
Condorelli, A1
Cornacchia, L1
Guiducci, L1
Raucci, M1
Benati, E1
Mirra, M1
Peris, K7
Lai, M1
Pellacani, G3
Longo, C1
Ulrich, M2
Reinhold, U3
Falqués, M1
Rodriguez Azeredo, R1
Stockfleth, E9
Iglesias-Puzas, A1
Batalla, A1
Suh-Oh, HJ1
Flórez, A1
Simon, JC2
Dominicus, R1
Karl, L1
Rodríguez, R1
Willers, C2
Dirschka, T10
Nieves, D1
Puig-Peiró, R1
Ferrándiz, C1
Plazas, MJ1
Brosa, M1
Alarcon, I3
Malvehy, J4
Puig, S4
Tolley, K2
Kemmett, D1
Thybo, S1
Nasr, R1
Smethurst, H1
Szeimies, RM5
Prechtl, A2
Melzer, A2
Sibbring, GC1
Gholam, P1
Fink, C1
Bosselmann, I1
Enk, AH1
Montoya, J1
Rodríguez-Azeredo, R1
Nguyen, HP1
Rivers, JK1
Herranz, P1
Morton, C2
Azeredo, RR1
Roldán-Marín, R2
Hadshiew, I1
Wojcik, R1
Lowin, J1
Vilardell, D1
Maeso, S1
Ruiz, L1
Lear, JT2
Schlaak, M1
Kerl, H2
Zwingers, T1
THIERS, H1
Jimenez, AR1
Florell, SR1
Donigan, JM1
Er, O1
Ag, S1
Ha, M1
Mb, R1
Mmc, M1
Mr, G1
Lpf, A1
Bai-Habelski, JC1
Medrano, K1
Palacio, A1
Oren-Shabtai, M1
Sloutsky, N1
Lapidoth, M2
Mimouni, D1
Chorny, I1
Snast, I1
Leshem, YA1
Friedland, R1
Hodak, E1
Klein, I1
Agmon, Y1
Levi, A1
Miller, AC1
Adjei, S1
Temiz, LA1
Tyring, SK2
García-Gil, MF1
Gracia-Cazaña, T1
Cerro-Muñoz, P1
Bernal-Masferrer, L1
Navarro-Bielsa, A1
Gilaberte, Y1
Silic, K2
Kammer, M1
Sator, PG1
Tanew, A2
Radakovic, S2
Trovato, E1
Fiorani, D1
Cartocci, A1
Cinotti, E1
Rubegni, P1
Gioppo, IS1
de Castro Martins, IM1
Santos, SS1
Preto, JFR1
Miola, AC1
Miot, HA1
Gollnick, H1
Ostendorf, R1
Kunstfeld, R1
Chabbert, C1
Levy, M1
Legrand, L1
Mir-Bonafé, JF1
Mir-Bonafé, M1
Mozos, A1
López-Sánchez, C1
Piquero-Casals, J1
de Dios-Velázquez, Á1
Mir-Bonafé, JM1
Rozas-Muñoz, E1
Salido-Vallejo, R2
Jiménez-Nájar, F1
Garnacho-Sucedo, G1
Vélez, A1
Wójcicka, K1
Szepietowski, JC1
Abdalla, BMZ1
Simas Pedreiro, B1
Garcia Morales, A1
Krutman Zveibil, D1
Paschoal, FM1
Bernardini, N1
Proietti, I1
Tolino, E1
Zuber, S1
Mambrin, A1
Balduzzi, V1
Marchesiello, A1
Anzalone, A1
Colapietra, D1
Potenza, C1
Skroza, N1
Meierhofer, C1
Urban, MV1
Berman, B6
Bukhalo, M2
Hanke, CW5
Jarner, MF1
Larsson, T3
Siegel, DM1
Skov, T4
Cortelazzi, C2
Odorici, G1
Castagnetti, E1
Di Nuzzo, S2
Blauvelt, A1
Kempers, S1
Lain, E1
Schlesinger, T1
Tyring, S1
Forman, S1
Ablon, G1
Martin, G1
Wang, H1
Cutler, DL1
Fang, J1
Kwan, MR1
Arisi, M2
Rossi, MT1
Spiazzi, L1
Guasco Pisani, E1
Venturuzzo, A1
Rovati, C1
Tomasi, C1
Venturini, M1
Calzavara-Pinton, PG1
Fine, JD1
Dewan, A1
Miller, JL1
Bucko, AD1
Jarratt, M1
Stough, DB1
Kyhl, L1
Villumsen, J2
Hall, A1
Dréno, B1
Cerio, R1
Nart, IF1
de Casas, AR1
Kaleci, S1
Bower, C1
Swanson, N6
Pariser, DM1
Weiss, JS1
Siegel, D1
Ortega Del Olmo, R1
Sotiriou, E4
Evangelou, G1
Papadavid, E1
Apalla, Z4
Vrani, F2
Vakirlis, E2
Panagiotou, M1
Stefanidou, M1
Pombou, T1
Krasagakis, K1
Rigopoulos, D1
Ioannides, D4
Galimberti, GN1
Harwood, CA1
Serra-Guillén, C2
Østerdal, ML1
Carbone, A1
Sperduti, I1
De Simone, P1
Piemonte, P1
Ferrari, A1
Buccini, P1
Silipo, V1
Iorio, A1
Frascione, P1
Eibenschutz, L1
Bagatin, E1
Heerfordt, IM1
Bieliauskiene, G1
Wulf, HC1
Lazaridou, E1
Sideris, N1
Kirmanidou, E1
Lallas, A1
Nagore, E1
Bancalari, E1
Kindem, S1
Sanmartín, O1
Llombart, B1
Requena, C1
Serra-Guillén, I1
Calomarde, L1
Diago, A1
Bernia, E1
Guillén, C1
Schmitz, L1
Stücker, M1
Gambichler, T1
Giuffrida, R1
Borgia, F1
Cannavò, SP1
Vicentini, C1
Vignion-Dewalle, AS1
Thecua, E1
Lecomte, F1
Maire, C1
Deleporte, P1
Béhal, H1
Kerob, D1
Duhamel, A1
Mordon, S1
Mortier, L1
Ruini, C1
Hartmann, D1
Bastian, M1
Ruzicka, T1
French, LE1
Berking, C1
von Braunmühl, T1
Sousa, ACDS1
Campos, MAC1
Baptista, AM1
Menezes, NMBVN1
Zavattaro, E1
Veronese, F1
Landucci, G1
Tarantino, V1
Savoia, P1
Ramelyte, E1
Imhof, L1
Morton, CA1
Balcere, A1
Rone Kupfere, M1
Čēma, I1
Krūmiņa, A1
Gutiérrez García-Rodrigo, C1
Pellegrini, C1
Piccioni, A2
Tambone, S3
Fargnoli, MC3
Dominguez-Cruz, J1
Ruiz-Villaverde, R1
Rizvi, SM1
Veierød, MB1
Mørk, G1
Helsing, P1
Gjersvik, P1
Tzogani, K1
Straube, M1
Hoppe, U1
Kiely, P1
O'Dea, G1
Enzmann, H1
Salmon, P1
Salmonson, T1
Pignatti, F1
Tallon, B1
Turnbull, N1
Smith, CC2
Kaur, M2
Goldenberg, G3
Buinauskaite, E1
Maciulaitis, R1
Buinauskiene, J1
Valiukeviciene, S1
Puviani, M1
Barcella, A1
Milani, M1
Werschler, WP1
Knudsen, KM2
Goncalves, J1
Iglesias-García, P1
Díaz, A1
Vegter, S1
Gupta, G3
Aractingi, S3
Alomar, A3
Dakovic, R3
Klein, A1
Karrer, S1
Horner, C1
Werner, A1
Heinlin, J1
Zeman, F1
Koller, M1
Landthaler, M1
Gruber, M1
Graf, B1
Hansen, E1
Kerscher, C1
Boccaletti, V1
Zucchi, A1
Conti, ML1
Montanari, P1
Feliciani, C1
Fabrizi, G1
Pagliarello, C1
Karmisholt, KE1
Bettencourt, MS1
Capizzi, R1
Jambusaria-Pahlajani, A1
Ortman, S1
Schmults, CD1
Liang, C1
Xie, C1
Pan, Y1
McLean, C1
Mar, V1
Wolfe, R1
Kelly, JW1
Ricci, F1
Neri, L1
Fania, L1
Guerriero, C1
Gaide, O1
Clayton, H1
Girardin, M1
Kuonen, F1
Zane, C1
Fabiano, A1
Calzavara-Pinton, P1
Shabbir, AQ1
MacNeil, T1
Gandy, J1
Labadie, B1
Bierman, D1
Zachary, C1
Siller, G1
Gebauer, K1
Welburn, P1
Katsamas, J1
Ogbourne, SM1
Schmid-Wendtner, MH1
Wendtner, CM1
Chovarda, E2
Lefaki, I1
Devliotou-Panagiotidou, D1
Paternò, EJ1
Chimenti, S1
Beer, KR1
Wu, J1
Rosen, T1
Levy, S4
Abramovits, W1
Kulp, J3
Rigel, DS1
Fein, MC1
Adams, M1
Furst, J1
Meng, TC1
Stollery, N1
Quist, SR1
Gollnick, HP1
Bruce, S1
Goussi, C1
Trigoni, A1
Göksu, Y1
Hofbauer, G1
Serra, A1
Nowak, A1
Adatto, M1
Halachmi, S1
GLUSHIKHIN, MA1
PICKRELL, K1
MATTON, G1
HUGER, W1
POUND, E1

Clinical Trials (12)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Prospective Comparator Controlled Randomized Exploratory Study on the Efficacy of LAS 41005 Compared to Cryotherapy in Subjects With Hyperkeratotic Actinic Keratosis[NCT01358851]Phase 267 participants (Actual)Interventional2011-04-30Completed
Long-term Effects of Aldara® 5% Cream and Solaraze® 3% Gel in the Treatment of Actinic Keratoses on the Face or Scalp With Respect to the Risk of Progression to In-situ and Invasive Squamous Cell Carcinoma[NCT01453179]Phase 4221 participants (Actual)Interventional2011-10-31Completed
A Phase 3, Double-Blind, Vehicle-Controlled, Randomized, Parallel Group, Multicenter, Efficacy and Safety Study of KX2-391 Ointment 1% in Adult Subjects With Actinic Keratosis on the Face or Scalp[NCT03285477]Phase 3351 participants (Actual)Interventional2017-09-18Completed
A Phase 3, Double-Blind, Vehicle-Controlled, Randomized, Parallel Group, Multicenter, Efficacy and Safety Study of KX2-391 Ointment 1% in Adult Subjects With Actinic Keratosis on the Face or Scalp[NCT03285490]Phase 3351 participants (Actual)Interventional2017-09-15Completed
A Phase 2, Single-Arm, Open-Label, Single Center Study to Assess Efficacy and Safety of Tirbanibulin Ointment 1% in Adult Subjects With Superficial Basal Cell Carcinoma (sBCC) on the Neck, Trunk, or Extremities (Excluding Axilla, Anogenital, and Face/Scal[NCT05713760]Phase 210 participants (Anticipated)Interventional2023-04-17Recruiting
A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp[NCT01541553]Phase 3367 participants (Actual)Interventional2012-03-31Completed
A Multi-center, OPen, InvEstigator Initiated Phase IV Clinical TRial to Evaluate the Efficacy and SaFety of Ingenol Mebutate Gel 0.015% on Face and Scalp & 0.05% on Trunk and Extremities in KorEan Patient With ACtinic KeraTosis (PERFECT)[NCT02716714]Phase 477 participants (Actual)Interventional2015-04-30Completed
Aminolevulinic Acid-photodynamic Therapy for Facial Actinic Keratosis Treatment and Prevention: A Long-term (3 Years) Follow-up of Prospective, Randomized, Multicenter-clinical Trial[NCT03642535]Phase 4300 participants (Anticipated)Interventional2018-08-30Recruiting
A Phase 3, Randomized, Double-blinded, Placebo-controlled, Multicenter, Efficacy and Safety Study of Six Weeks of Treatment With Imiquimod Creams for Actinic Keratoses[NCT00603798]Phase 3490 participants (Actual)Interventional2008-01-31Completed
Evaluation of Topical Application of 5% Imiquimod, 0.05% Imiquimod and 0.05% Nanoencapsulated Imiquimod Gel in the Treatment of Actinic Cheilitis: a Randomized Controlled Trial[NCT04219358]Phase 149 participants (Actual)Interventional2019-03-23Terminated (stopped due to Study terminated because of COVID19 pandemics.)
A Phase 3, Randomized, Double-blinded, Placebo-controlled, Multicenter, Efficacy and Safety Study of Four Weeks of Treatment With Imiquimod Creams for Actinic Keratoses[NCT00605176]Phase 3479 participants (Actual)Interventional2008-01-31Completed
Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year After Completion of Studies GW01-0702, GW01-0703, GW01-0704, and GW01-0705[NCT00668733]179 participants (Actual)Observational2008-04-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Number of Participants With Clinically Significant Safety Observations- Electrocardiograms (ECGs)

ECG parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals. Clinical significance was determined by the investigator. (NCT03285477)
Timeframe: From Baseline (Day 1 predose) up to Day 57

InterventionParticipants (Count of Participants)
Placebo0
KX2-391 Ointment 1%0

Number of Participants With Clinically Significant Safety Observations- Physical Examination

A physical examination included weight and height measurements was performed. Clinical significance was determined by the investigator. (NCT03285477)
Timeframe: From Baseline (Day 1 predose) up to Day 57

InterventionParticipants (Count of Participants)
Placebo0
KX2-391 Ointment 1%0

Number of Participants With Clinically Significant Safety Observations- Vital Signs

Vital signs included measurement of pulse rate, systolic and diastolic blood pressure, respiratory rate, and body temperature. Clinical significance was determined by the investigator. (NCT03285477)
Timeframe: From Baseline (Day 1 predose) up to Day 57

InterventionParticipants (Count of Participants)
Placebo0
KX2-391 Ointment 1%0

Percentage of Participants With Complete (100%) Clearance of Actinic Keratosis (AK) Lesions

Complete clearance rate was defined as the percentage of participants at Day 57 with no clinically visible AK lesions in the treatment area. (NCT03285477)
Timeframe: Day 57

Interventionpercentage of participants (Number)
Placebo5
KX2-391 Ointment 1%44

Percentage of Participants With Partial Clearance Rate of Actinic Keratosis Lesions at Day 57

Partial clearance rate of AK lesions was defined as the percentage of participants with a greater than or equal to (>=) 75% reduction in the number of AK lesions identified at Baseline (Day 1 predose) in the treatment area. (NCT03285477)
Timeframe: Day 57

Interventionpercentage of participants (Number)
Placebo16
KX2-391 Ointment 1%68

Number of Participants With Adverse Event (AE), Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Events of Special Interests

An AE was defined as any untoward medical occurrence in participant which does not necessarily have causal relationship with treatment. An AE was any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal product, whether or not considered related to medicinal product. An SAE was any untoward medical occurrence that at any dose resulted in death; was life threatening; required persistent/significant disability/incapacity; resulted in initial or prolonged in patient hospitalization; was congenital anomaly/birth defect or otherwise considered medically important. TEAEs (serious and non-serious) were defined as either those AEs with onset after first dose or those pre-existing AEs that worsen after first dose. Events of special interest included skin cancers (including basal cell carcinoma, squamous cell carcinoma, melanoma and their location and treatment area), ocular exposure, overdose, and pregnancy. (NCT03285477)
Timeframe: Baseline (Day 1 predose) up to Day 57

,
InterventionParticipants (Count of Participants)
Participants with AEParticipants with any TEAEParticipants with SAEParticipants with events of special interest
KX2-391 Ointment 1%665705
Placebo625724

Number of Participants With Adverse Events, Serious Adverse Events, Events of Special Interests Within the Treatment Area After Day 57 and up to 12 Months Post-Day 57

An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. An SAE was any untoward medical occurrence that at any dose resulted in death; was life threatening; required persistent/significant disability/incapacity; resulted in initial or prolonged in patient hospitalization; was congenital anomaly/birth defect or otherwise considered medically important. Events of special interest included skin cancers (including basal cell carcinoma, squamous cell carcinoma, melanoma and their location and treatment area), ocular exposure, overdose, and pregnancy. (NCT03285477)
Timeframe: From Day 57 up to 12-months post-Day 57

,
InterventionParticipants (Count of Participants)
Participants with any AEParticipants with any SAEParticipants with events of special interest
KX2-391 Ointment 1%410
Placebo000

Number of Participants With Clinically Significant Safety Observations- Hematology, Blood Chemistry, Urinalysis

Assessed laboratory parameters included hematology, blood chemistry and urinalysis. Clinical significance and abnormal observations were determined by the investigator. (NCT03285477)
Timeframe: From Baseline (Day 1 predose) up to Day 57

,
InterventionParticipants (Count of Participants)
HematologyBlood chemistryUrinalysis
KX2-391 Ointment 1%013
Placebo010

Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)

Maximal post baseline LSR was defined as the highest grade of any LSR reported at any post baseline visits for a participant. The LSR assessment was an Investigator's (or sub-investigator's) assessment of the following signs on the treatment area: erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. The LSRs were graded on a 4-point scale ranging from 0=absent, 1=mild (slightly, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense). (NCT03285477)
Timeframe: Day 57

,
InterventionParticipants (Count of Participants)
Erythema-Grade 0Erythema-Grade 1Erythema-Grade 2Erythema-Grade 3Flaking/Scaling-Grade 0Flaking/Scaling-Grade 1Flaking/Scaling-Grade 2Flaking/Scaling-Grade 3Crusting-Grade 0Crusting-Grade 1Crusting-Grade 2Crusting-Grade 3Swelling-Grade 0Swelling-Grade 1Swelling-Grade 2Swelling-Grade 3Vesiculation/Pustulation-Grade 0Vesiculation/Pustulation-Grade 1Vesiculation/Pustulation-Grade 2Vesiculation/Pustulation-Grade 3Erosion/Ulceration-Grade 0Erosion/Ulceration-Grade 1Erosion/Ulceration-Grade 2Erosion/Ulceration-Grade 3
KX2-391 Ointment 1%64811651670781184692021075512115814211551550
Placebo8184110729014014033301631210174200168800

Number of Participants With Pigmentation and Scarring in the Treatment Area

Absence or presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment area were assessed. (NCT03285477)
Timeframe: Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57

,
InterventionParticipants (Count of Participants)
Hypopigmentation: BaselineHypopigmentation: Day 5Hypopigmentation: Day 8Hypopigmentation: Day 15Hypopigmentation: Day 29Hypopigmentation: 57Hyperpigmentation: BaselineHyperpigmentation: Day 5Hyperpigmentation: Day 8Hyperpigmentation: Day 15Hyperpigmentation: Day 29Hyperpigmentation: Day 57Scarring: BaselineScarring: Day 5Scarring: Day 8Scarring: Day 15Scarring: Day 29Scarring: Day 57
KX2-391 Ointment 1%2111101217132218172018121287897
Placebo2119212323202724232625231089777

Overall Change From Baseline in Actinic Keratosis Lesion Counts at Days 8, 15, 29 and 57

Overall the change from baseline in lesion count at each visit were summarized and reported using descriptive statistics by treatment location (face or scalp). (NCT03285477)
Timeframe: Days 8, 15, 29 and 57

,
Interventionlesion count (Median)
Day 8Day 15Day 29Day 57
KX2-391 Ointment 1%-1.0-4.0-4-5.0
Placebo0.00.0-1.0-1.0

Percentage of Participants With Recurrence of Actinic Keratosis Lesions Who Achieved Complete Clearance at Day 57

Recurrence rate was estimated based on Kaplan-Meier method, with recurrence define as appearance of any AK lesions in the treatment area, including those recurred or newly identified. (NCT03285477)
Timeframe: 3, 6, 9 and 12 months post-Day 57

Interventionpercentage of participants (Number)
3 Months Post-Day 576 Months Post-Day 579 Months Post-Day 5712 months Post-Day 57
KX2-391 Ointment 1%33303318

Number of Participants With Clinically Significant Safety Observations- Electrocardiograms (ECGs)

ECG parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals. Clinical significance was determined by the investigator. (NCT03285490)
Timeframe: From Baseline (Day 1 predose) up to Day 57

InterventionParticipants (Count of Participants)
Placebo0
KX2-391 Ointment 1%0

Number of Participants With Clinically Significant Safety Observations- Physical Examination

A physical examination included weight and height measurements was performed. Clinical significance was determined by the investigator. (NCT03285490)
Timeframe: From Baseline (Day 1 predose) up to Day 57

InterventionParticipants (Count of Participants)
Placebo0
KX2-391 Ointment 1%0

Number of Participants With Clinically Significant Safety Observations- Vital Signs

Vital signs included measurement of pulse rate, systolic and diastolic blood pressure, respiratory rate, and body temperature. Clinical significance was determined by the investigator. (NCT03285490)
Timeframe: From Baseline (Day 1 predose) up to Day 57

InterventionParticipants (Count of Participants)
Placebo0
KX2-391 Ointment 1%0

Percentage of Participants With Complete (100%) Clearance of Actinic Keratosis (AK) Lesions

Complete clearance rate was defined as the percentage of participants at Day 57 with no clinically visible AK lesions in the treatment area. (NCT03285490)
Timeframe: Day 57

Interventionpercentage of participants (Number)
Placebo13
KX2-391 Ointment 1%54

Percentage of Participants With Partial Clearance Rate of Actinic Keratosis Lesions at Day 57

Partial clearance rate of AK lesions was defined as the percentage of participants with a greater than or equal to (>=) 75% reduction in the number of AK lesions identified at Baseline (Day 1 predose) in the treatment area. (NCT03285490)
Timeframe: Day 57

Interventionpercentage of participants (Number)
Placebo20
KX2-391 Ointment 1%76

Number of Participants With Adverse Event (AE), Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Events of Special Interests

An AE was defined as any untoward medical occurrence in participant which does not necessarily have causal relationship with treatment. An AE was any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal product, whether or not considered related to medicinal product. An SAE was any untoward medical occurrence that at any dose resulted in death; was life threatening; required persistent/significant disability/incapacity; resulted in initial or prolonged in patient hospitalization; was congenital anomaly/birth defect or otherwise considered medically important. TEAEs (serious and non-serious) were defined as either those AEs with onset after first dose or those pre-existing AEs that worsen after first dose. Events of special interest included skin cancers (including basal cell carcinoma, squamous cell carcinoma, melanoma and their location and treatment area), ocular exposure, overdose, and pregnancy. (NCT03285490)
Timeframe: Baseline (Day 1 predose) up to Day 57

,
InterventionParticipants (Count of Participants)
Participants with AEParticipants with any TEAEParticipants with any SAEParticipants with events of special interest
KX2-391 Ointment 1%716714
Placebo736744

Number of Participants With Adverse Events, Serious Adverse Events, Events of Special Interests Within the Treatment Area After Day 57 and up to 12 Months Post-Day 57

An AE was defined as any untoward medical occurrence in participant which does not necessarily have causal relationship with treatment. An AE was any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal product, whether or not considered related to medicinal product. An SAE was any untoward medical occurrence that at any dose resulted in death; was life threatening; required persistent/significant disability/incapacity; resulted in initial or prolonged in patient hospitalization; was congenital anomaly/birth defect or otherwise considered medically important. Events of special interest included skin cancers (including basal cell carcinoma, squamous cell carcinoma, melanoma and their location and treatment area), ocular exposure, overdose, and pregnancy. (NCT03285490)
Timeframe: From Day 57 up to 12-months post-Day 57

,
InterventionParticipants (Count of Participants)
Participants with any AEParticipants with any SAEParticipants with events of special interest
KX2-391 Ointment 1%200
Placebo001

Number of Participants With Clinically Significant Safety Observations- Hematology, Blood Chemistry, Urinalysis

Assessed laboratory parameters included hematology, blood chemistry and urinalysis. Clinical significance and abnormal observations were determined by the investigator. (NCT03285490)
Timeframe: From Baseline (Day 1 predose) up to Day 57

,
InterventionParticipants (Count of Participants)
HematologyBlood chemistryUrinalysis
KX2-391 Ointment 1%001
Placebo040

Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)

Maximal post baseline LSR was defined as the highest grade of any LSR reported at any post baseline visits for a participant. The LSR assessment was an Investigator's (or sub-investigator's) assessment of the following signs on the treatment area: erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. The LSRs were graded on a 4-point scale ranging from 0=absent, 1=mild (slightly, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense). (NCT03285490)
Timeframe: Day 57

,
InterventionParticipants (Count of Participants)
Erythema-Grade 0Erythema-Grade 1Erythema-Grade 2Erythema-Grade 3Flaking/Scaling-Grade 0Flaking/Scaling-Grade 1Flaking/Scaling-Grade 2Flaking/Scaling-Grade 3Crusting-Grade 0Crusting-Grade 1Crusting-Grade 2Crusting-Grade 3Swelling-Grade 0Swelling-Grade 1Swelling-Grade 2Swelling-Grade 3Vesiculation/Pustulation-Grade 0Vesiculation/Pustulation-Grade 1Vesiculation/Pustulation-Grade 2Vesiculation/Pustulation-Grade 3Erosion/Ulceration-Grade 0Erosion/Ulceration-Grade 1Erosion/Ulceration-Grade 2Erosion/Ulceration-Grade 3
KX2-391 Ointment 1%34711117860902092513051104720116611011561840
Placebo798113082692111481960169400172100171200

Number of Participants With Pigmentation and Scarring in the Treatment Area

Absence or presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment area were assessed. (NCT03285490)
Timeframe: Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57

,
InterventionParticipants (Count of Participants)
Hypopigmentation: BaselineHypopigmentation: Day 5Hypopigmentation: Day 8Hypopigmentation: Day 15Hypopigmentation: Day 29Hypopigmentation: Day 57Hyperpigmentation: BaselineHyperpigmentation: Day 5Hyperpigmentation: Day 8Hyperpigmentation: Day 15Hyperpigmentation: Day 29Hyperpigmentation: Day 57Scarring: BaselineScarring: Day 5Scarring: Day 8Scarring: Day 15Scarring: Day 29Scarring: Day 57
KX2-391 Ointment 1%302830313229363334322925111311999
Placebo2626232121213330302724259889810

Overall Change From Baseline in Actinic Keratosis Lesion Counts at Days 8, 15, 29 and 57

Overall the change from baseline in lesion count at each visit were summarized and reported using descriptive statistics by treatment location (face or scalp). (NCT03285490)
Timeframe: Days 8, 15, 29 and 57

,
Interventionlesion count (Median)
Day 8Day 15Day 29Day 57
KX2-391 Ointment 1%-1.0-4.0-5.0-5.0
Placebo0.0-1.0-1.0-1.0

Percentage of Participants With Recurrence of Actinic Keratosis Lesions Who Achieved Complete Clearance at Day 57

Recurrence rate was estimated based on Kaplan-Meier method, with recurrence define as appearance of any AK lesions in the treatment area, including those recurred or newly identified. (NCT03285490)
Timeframe: 3, 6, 9 and 12 months post-Day 57

Interventionpercentage of participants (Number)
3 months post-Day 576 months post-Day 579 months post-Day 5712 months post-Day 57
KX2-391 Ointment 1%27312723

Complete Clearance of AKs at Week 11

To determine the 11-week rate of complete clearance of AKs (defined as no clinically visible AKs) in the selected treatment area using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone. (NCT01541553)
Timeframe: 11 weeks

Interventionparticipants (Number)
PEP005 Gel, 0.015%101
Vehicle Gel80

Partial Clearance of AKs at Week 11

Partial clearance of AKs at Week 11, defined as 75% or greater reduction from baseline in the number of clinically visible AKs in the selected treatment area at Week 11 (NCT01541553)
Timeframe: Week 11

Interventionparticipants (Number)
PEP005 Gel, 0.015%130
Vehicle Gel109

Percentage Change From Baseline in Number of AKs at Week 11

Percentage change from baseline in number of AKs at Week 11 (NCT01541553)
Timeframe: Baseline to week 11

Interventionpercentage of change (Mean)
PEP005 Gel, 0.015%81.1
Vehicle Gel74.1

Percentage Change of the Number of AK Lesions in the Selected Treatment Area

Percentage change from baseline in the number of actinic keratiosis(AK) lesions in the selected treatment area on Day 57 was analyzed. (NCT02716714)
Timeframe: Baseline and Day 57

Interventionpercentage change (Mean)
Ingenol Mebutate Gel 0.015%-80.08
Ingenol Mebutate Gel 0.05%-88.89

Percentage Change of the Number of AK Lesions in the Selected Treatment Area of CC Group

Percentage change from baseline in the number of actinic keratiosis(AK) lesions at Month 6 in the selected treatment area in complete clearance(CC) Group was analyzed. (NCT02716714)
Timeframe: at 6 months from baseline

InterventionPercentage change (Mean)
Ingenol Mebutate Gel 0.015%-88.65
Ingenol Mebutate Gel 0.05%-85.71

Time to Relapse in CC Group

Time to relapse in complete clearance(CC) Group was analyzed. Median survival time with 95% confidence interval was calculated by Kaplan-Meier method. (NCT02716714)
Timeframe: at 6 months

Interventiondays (Median)
Ingenol Mebutate Gel 0.015%NA
Ingenol Mebutate Gel 0.05%203

Change From Baseline in Quality of Life (Skindex-29)

Skindex-29 is a self-administered QoL questionnaire comprised of 29 items scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 items), symptomatic (7 items), and functional (12 items), with domain scores ranging from 0 to 40, 28, and 48, respectively. Lower scores for each of the domains represents a better Quality of life. (NCT02716714)
Timeframe: at 29 and 57 days from baseline

,
Interventionunits on a scale (Mean)
Emotions(Baseline)Emotions(Day 29)Emotions(Day 57)Emotions(Day 29-Baseline)Emotions(Day 57-Baseline)Symptoms(Baseline)Symptoms(Day 29)Symptoms(Day 57)Symptoms(Day 29-Baseline)Symptoms(Day 57-Baseline)Functioning(Baseline)Functioning(Day 29)Functioning(Day 57)Functioning(Day 29-Baseline)Functioning(Day 57-Baseline)
Ingenol Mebutate Gel 0.015%20.5721.2115.28-0.42-6.4616.4520.1612.413.09-4.768.5417.1010.588.021.45
Ingenol Mebutate Gel 0.05%27.2212.5012.78-14.72-14.4431.3513.8912.70-17.46-18.6513.435.563.24-7.87-10.19

Medication for Actinic Keratosis

The count of participants in complete clearance(CC) group and Non-CC group who administered medication for actinic keratosis on the selected treatment area after Day 57 was collected. (NCT02716714)
Timeframe: from 57 days to 6 months

,
InterventionParticipants (Count of Participants)
FluorouracilImiquimod
CC Group01
Non-CC Group10

Non-Drug Treatment/Surgery for Actinic Keratosis

The count of participants in complete clearance(CC) group and Non-CC group who received non-drug treatment/surgery for actinic keratosis on the selected treatment area after Day 57 was collected. (NCT02716714)
Timeframe: from 57 days to 6 months

,
InterventionParticipants (Count of Participants)
Skin cryotherapyPhotodynamic therapyPhototherapySkin lesion excisionWound treatmentBiopsy skin
CC Group500110
Non-CC Group411001

Recurrence Rate in CC Group

Recurrence rate in complete clearance(CC) group was analyzed. (NCT02716714)
Timeframe: at 6 months

,
InterventionParticipants (Count of Participants)
Recurrence rateCensored
Ingenol Mebutate Gel 0.015%542
Ingenol Mebutate Gel 0.05%25

Sustained CC Rate in CC Group

Sustained Complete Clearance means that Complete Clearance was maintained until Month 6 in complete clearance (CC) group and sustained complete clearance(CC) rate at month 6 for complete clearance(CC) group was analyzed. (NCT02716714)
Timeframe: at 6 months

,
InterventionParticipants (Count of Participants)
Sustained CCRecurrence
Ingenol Mebutate Gel 0.015%425
Ingenol Mebutate Gel 0.05%61

Treatment Satisfaction Questionnaire for Medication (TSQM)

"Participants personally completed the tool to evaluate satisfaction with drug treatment. It consisted of 4 areas of Effectiveness, side effect, convenience, and global satisfaction, with a total of 14 sub-items. The full mark is 100, and it is divided in four stages as follows.~Very good: 76 -100 score~Good: 51-75 score~Not bad: 26-50 score~Bad: 0-25 score Scores for each area ranged from 0 to 100, with higher scores indicating that fewer side effects had occurred and greater treatment satisfaction." (NCT02716714)
Timeframe: at 29 and 57 days from baseline

,
Interventionunits on a scale (Mean)
Effectiveness(Day 29)Effectiveness(Day 57)Side-effect(Day 29)Side-effect(Day 57)Convenience(Day 29)Convenience(Day 57)Global satisfaction(Day 29)Global satisfaction(Day 57)
Ingenol Mebutate Gel 0.015%57.6262.6784.4889.2660.7565.1059.2260.60
Ingenol Mebutate Gel 0.05%61.1170.3791.6791.4161.1165.4365.0863.49

Cosmetic Outcomes Assessment (COA)

The investigator rated the subject's Cosmetic Outcomes Assessment(COA) using 5 grades (Very good, Good, No change, Bad, Very bad), and results were as follows. (NCT02716714)
Timeframe: at 29 and 57 days from baseline

InterventionParticipants (Count of Participants)
Day 2972105067Day 2972105068Day 5772105067Day 5772105068
Very goodGoodNo changeBadVery bad
Ingenol Mebutate Gel 0.015%16
Ingenol Mebutate Gel 0.05%3
Ingenol Mebutate Gel 0.015%33
Ingenol Mebutate Gel 0.05%4
Ingenol Mebutate Gel 0.015%5
Ingenol Mebutate Gel 0.05%1
Ingenol Mebutate Gel 0.015%8
Ingenol Mebutate Gel 0.015%0
Ingenol Mebutate Gel 0.015%17
Ingenol Mebutate Gel 0.015%39
Ingenol Mebutate Gel 0.05%5
Ingenol Mebutate Gel 0.015%6
Ingenol Mebutate Gel 0.015%2
Ingenol Mebutate Gel 0.05%0

Local Skin Reactions (LSR)

Six local skin reaction (LSR) signs were predefined and were assessed for presence and intensity at each visit. These included: Erythema, edema, Weeping/Exudate, Flaking/Scaling/Dryness, Scabbing/Crusting and Erosion/Ulceration. The LSRs were scored as 0=none, 1=mild, 2=moderate, 3=severe. Summary of LSR - area under the curve (AUC) of sum of LSR scores (days). (NCT00603798)
Timeframe: The time period for the AUC extends to 8 weeks after the end of treatment (Week 17)

Interventionunits on a scale * days (Mean)
3.75% Imiquimod Cream413.5
2.5% Imiquimod Cream372.0
Placebo Cream188.6

Number of Participants With Complete Clearance of AK Lesions

"Subject status with respect to complete clearance of AK lesions at End of Study (EOS), ie, the Week 17 visit. Complete clearance was defined as the absence of clinically visible or palpable AK lesions in the treatment area. All lesions within the identified treatment area were included in the count, even if the lesion was a new lesion or subclinical lesion that had not been identified at Baseline." (NCT00603798)
Timeframe: End of Study the Week 17 visit

Interventionparticipants (Number)
3.75% Imiquimod Cream55
2.5% Imiquimod Cream41
Placebo Cream9

Number of Participants With Partial Clearance of AK Lesions

Subject status with respect to complete clearance of AK lesions at End of Study (EOS), defined as at least a 75% reduction in the number of AK lesions in the treatment area compared with Baseline. (NCT00603798)
Timeframe: End of Study the Week 17 visit

Interventionparticipants (Number)
3.75% Imiquimod Cream87
2.5% Imiquimod Cream70
Placebo Cream21

Percent Change From Baseline in AK Lesion Count

Percent change from Baseline to end of study (EOS) in investigator counts of AK lesions. A negative percent change is better than a positive percent change. (NCT00603798)
Timeframe: At all visits - Baseline through the Week 17 EOS visit

Interventionpercentage of participants (Median)
3.75% Imiquimod Cream-80.0
2.5% Imiquimod Cream-66.7
Placebo Cream-23.6

Local Skin Reactions

Six local skin reaction (LSR) signs were predefined and were assessed for presence and intensity at each study visit. These included: Erythema, Edema, Weeping/Exudate, Flaking/Scaling/Dryness, Scabbing/Crusting and Erosion/Ulceration. The LSRs were scored as 0=none, 1=mild, 2=moderate, 3=severe. Mean scores were summated over time (14 weeks) to yield a mean LSR AUC (area under the curve) (NCT00605176)
Timeframe: At all visits - from Baseline to End of study (Week 14)

Interventionunits on a scale * days (Mean)
3.75% Imiquimod Cream272.0
2.5% Imiquimod Cream242.5
Placebo Cream139.8

Number of Participants With Complete Clearance of AK Lesions

Subject status with respect to complete clearance of AK lesions at End of Study (EOS), ie, the Week 14 visit. Complete clearance was defined as the absence of clinically visible or palpable AK lesions in the treatment area. All lesions within the identified treatment area were included in the count, even if the lesion was a new lesion or 'subclinical' lesion that had not been identified at Baseline. (NCT00605176)
Timeframe: End of Study the Week 14 visit

Interventionparticipants (Number)
3.75% Imiquimod Cream57
2.5% Imiquimod Cream49
Placebo Cream10

Number of Participants With Partial Clearance of AK Lesions

Subject status with respect to partial clearance of AK lesions at end of study (EOS), defined as at least a 75% reduction in the number of AK lesions in the treatment area compared with Baseline. (NCT00605176)
Timeframe: End of Study the Week 14 visit

Interventionparticipants (Number)
3.75% Imiquimod Cream95
2.5% Imiquimod Cream77
Placebo Cream36

Percent Change From Baseline in AK Lesion Count

Percent change from Baseline to end of study (EOS) in investigator counts of AK lesions. (NCT00605176)
Timeframe: From baseline to End of Study the Week 14 visit

Interventionpercent change (Median)
3.75% Imiquimod Cream-81.8
2.5% Imiquimod Cream-71.8
Placebo Cream-25.0

Number of Participants With Recurrence of AK Lesions

The primary efficacy variable in this study was the absence of AK lesions(sustained clearance rate) in the previously treated area. (NCT00668733)
Timeframe: Up to one year

Interventionparticipants (Number)
2-Week Treatment Group52
3-Week Treatment Group41

Reviews

11 reviews available for salicylic acid and Keratosis, Actinic

ArticleYear
Improving the efficacy of photodynamic therapy for actinic keratosis: A comprehensive review of pharmacological pretreatment strategies.
    Photodiagnosis and photodynamic therapy, 2023, Volume: 43

    Topics: Aminolevulinic Acid; Diclofenac; Fluorouracil; Humans; Keratosis, Actinic; Photochemotherapy; Photos

2023
New Topical Treatment Options for Actinic Keratosis: A Systematic Review.
    Acta dermato-venereologica, 2016, Volume: 96, Issue:1

    Topics: Administration, Cutaneous; Aminoquinolines; Dermatologic Agents; Diterpenes; Drug Combinations; Faci

2016
Low-Dose 0.5% 5-Fluorouracil/10% Salicylic Acid Topical Solution in the Treatment of Actinic Keratoses.
    Journal of cutaneous medicine and surgery, 2016, Volume: 20, Issue:6

    Topics: Administration, Cutaneous; Antimetabolites, Antineoplastic; Drug Combinations; Fluorouracil; Humans;

2016
Tirbanibulin for the Treatment of Actinic Keratosis: A Review.
    Skin therapy letter, 2022, Volume: 27, Issue:4

    Topics: Acetamides; Administration, Topical; Humans; Keratosis, Actinic; Morpholines; Pyridines; Scalp; Trea

2022
Long-term clinical outcomes of imiquimod 5% cream vs. diclofenac 3% gel for actinic keratosis on the face or scalp: a pooled analysis of two randomized controlled trials.
    Journal of the European Academy of Dermatology and Venereology : JEADV, 2020, Volume: 34, Issue:1

    Topics: Adjuvants, Immunologic; Aged; Anti-Inflammatory Agents, Non-Steroidal; Carcinoma, Squamous Cell; Dic

2020
Therapeutic Options for the Treatment of Actinic Keratosis with Scalp and Face Localization.
    Acta dermatovenerologica Croatica : ADC, 2020, Volume: 28, Issue:2

    Topics: Carcinoma in Situ; Carcinoma, Squamous Cell; Decision Making; Face; Humans; Keratosis, Actinic; Prec

2020
Daylight photodynamic therapy: experience in the treatment of actinic keratosis in the San Gallicano Institute (Rome) and a review of literature.
    Giornale italiano di dermatologia e venereologia : organo ufficiale, Societa italiana di dermatologia e sifilografia, 2020, Volume: 155, Issue:3

    Topics: Aged; Aged, 80 and over; Cohort Studies; Face; Female; Humans; Keratosis, Actinic; Male; Middle Aged

2020
Prevalence, Discontinuation Rate, and Risk Factors for Severe Local Site Reactions with Topical Field Treatment Options for Actinic Keratosis of the Face and Scalp.
    Medicina (Kaunas, Lithuania), 2019, Apr-04, Volume: 55, Issue:4

    Topics: Administration, Topical; Antineoplastic Agents; Carcinoma, Squamous Cell; Face; Humans; Keratosis, A

2019
A network meta-analysis of the relative efficacy of treatments for actinic keratosis of the face or scalp in Europe.
    PloS one, 2014, Volume: 9, Issue:6

    Topics: Aminolevulinic Acid; Clinical Trials as Topic; Europe; Face; Humans; Keratosis, Actinic; Photochemot

2014
A network meta-analysis of the relative efficacy of treatments for actinic keratosis of the face or scalp in Europe.
    Journal of the European Academy of Dermatology and Venereology : JEADV, 2016, Volume: 30, Issue:9

    Topics: Europe; Face; Humans; Keratosis, Actinic; Photochemotherapy; Photosensitizing Agents; Scalp

2016
Imiquimod 3.75% cream (Zyclara) for the treatment of actinic keratoses.
    Expert opinion on pharmacotherapy, 2011, Volume: 12, Issue:3

    Topics: Adjuvants, Immunologic; Administration, Cutaneous; Aminoquinolines; Combined Modality Therapy; Cryos

2011

Trials

40 trials available for salicylic acid and Keratosis, Actinic

ArticleYear
Use of reflectance confocal microscopy to evaluate 5-fluorouracil 0.5%/salicylic acid 10% in the field-directed treatment of subclinical lesions of actinic keratosis: subanalysis of a Phase III, randomized, double-blind, vehicle-controlled trial.
    Journal of the European Academy of Dermatology and Venereology : JEADV, 2018, Volume: 32, Issue:3

    Topics: Aged; Antimetabolites, Antineoplastic; Cohort Studies; Double-Blind Method; Female; Fluorouracil; Hu

2018
A prospective randomized exploratory study comparing the efficacy of once-daily topical 0.5% 5-fluorouracil in combination with 10.0% salicylic acid (5-FU/SA) vs. cryosurgery for the treatment of hyperkeratotic actinic keratosis.
    Journal of the European Academy of Dermatology and Venereology : JEADV, 2015, Volume: 29, Issue:5

    Topics: Administration, Cutaneous; Aged; Aged, 80 and over; Cryosurgery; Drug Combinations; Facial Dermatose

2015
Efficacy of low-dose 5-fluorouracil/salicylic acid in actinic keratoses in relation to treatment duration.
    Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG, 2015, Volume: 13, Issue:5

    Topics: Adult; Aged; Aged, 80 and over; Antimetabolites, Antineoplastic; Dose-Response Relationship, Drug; D

2015
Topical treatment of actinic keratoses with low-dose 5-fluorouracil in combination with salicylic acid--pilot study.
    Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG, 2010, Volume: 8, Issue:3

    Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Anti-Infective Agents; Drug Combinations; F

2010
Low-dose 5-fluorouracil in combination with salicylic acid as a new lesion-directed option to treat topically actinic keratoses: histological and clinical study results.
    The British journal of dermatology, 2011, Volume: 165, Issue:5

    Topics: Administration, Cutaneous; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Diclofe

2011
Randomized controlled trial for evaluation of efficacy and pain during photodynamic therapy for actinic keratosis of face and scalp comparing two irradiation protocols.
    Photodiagnosis and photodynamic therapy, 2022, Volume: 37

    Topics: Aminolevulinic Acid; Face; Humans; Keratosis, Actinic; Pain; Photochemotherapy; Photosensitizing Age

2022
Efficacy of two different methods of cold air analgesia for pain relief in PDT of actinic keratoses of the head region - a randomized controlled comparison study.
    Photodiagnosis and photodynamic therapy, 2022, Volume: 40

    Topics: Aminolevulinic Acid; Humans; Keratosis, Actinic; Pain; Photochemotherapy; Photosensitizing Agents; S

2022
The impact of occlusive vs non-occlusive application of 5-aminolevulinic acid (BF-200 ALA) on the efficacy and tolerability of photodynamic therapy for actinic keratosis on the scalp and face: A prospective within-patient comparison trial.
    Photodermatology, photoimmunology & photomedicine, 2021, Volume: 37, Issue:1

    Topics: Aged; Aged, 80 and over; Aminolevulinic Acid; Face; Female; Gels; Humans; Keratosis, Actinic; Male;

2021
Efficacy and safety of ingenol disoxate gel in field treatment of actinic keratosis on full face, scalp or large area (250 cm2) on the chest: results of four phase 3 randomized controlled trials.
    Dermatology online journal, 2020, Oct-15, Volume: 26, Issue:10

    Topics: Administration, Cutaneous; Aged; Dermatologic Agents; Diterpenes; Face; Female; Gels; Humans; Kerato

2020
Comparative study of imiquimod 3.75% vs. photodynamic therapy for actinic keratosis of the scalp.
    Photodermatology, photoimmunology & photomedicine, 2021, Volume: 37, Issue:5

    Topics: Aminolevulinic Acid; Humans; Imiquimod; Keratosis, Actinic; Male; Photochemotherapy; Photosensitizin

2021
Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis.
    The New England journal of medicine, 2021, 02-11, Volume: 384, Issue:6

    Topics: Acetamides; Administration, Topical; Aged; Double-Blind Method; Enzyme Inhibitors; Face; Female; Hum

2021
Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis.
    The New England journal of medicine, 2021, 02-11, Volume: 384, Issue:6

    Topics: Acetamides; Administration, Topical; Aged; Double-Blind Method; Enzyme Inhibitors; Face; Female; Hum

2021
Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis.
    The New England journal of medicine, 2021, 02-11, Volume: 384, Issue:6

    Topics: Acetamides; Administration, Topical; Aged; Double-Blind Method; Enzyme Inhibitors; Face; Female; Hum

2021
Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis.
    The New England journal of medicine, 2021, 02-11, Volume: 384, Issue:6

    Topics: Acetamides; Administration, Topical; Aged; Double-Blind Method; Enzyme Inhibitors; Face; Female; Hum

2021
Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis.
    The New England journal of medicine, 2021, 02-11, Volume: 384, Issue:6

    Topics: Acetamides; Administration, Topical; Aged; Double-Blind Method; Enzyme Inhibitors; Face; Female; Hum

2021
Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis.
    The New England journal of medicine, 2021, 02-11, Volume: 384, Issue:6

    Topics: Acetamides; Administration, Topical; Aged; Double-Blind Method; Enzyme Inhibitors; Face; Female; Hum

2021
Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis.
    The New England journal of medicine, 2021, 02-11, Volume: 384, Issue:6

    Topics: Acetamides; Administration, Topical; Aged; Double-Blind Method; Enzyme Inhibitors; Face; Female; Hum

2021
Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis.
    The New England journal of medicine, 2021, 02-11, Volume: 384, Issue:6

    Topics: Acetamides; Administration, Topical; Aged; Double-Blind Method; Enzyme Inhibitors; Face; Female; Hum

2021
Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis.
    The New England journal of medicine, 2021, 02-11, Volume: 384, Issue:6

    Topics: Acetamides; Administration, Topical; Aged; Double-Blind Method; Enzyme Inhibitors; Face; Female; Hum

2021
A randomized split-face clinical trial of conventional vs indoor-daylight photodynamic therapy for the treatment of multiple actinic keratosis of the face and scalp and photoaging.
    The Journal of dermatological treatment, 2022, Volume: 33, Issue:4

    Topics: Aminolevulinic Acid; Humans; Keratosis, Actinic; Photochemotherapy; Photosensitizing Agents; Scalp;

2022
Pharmacokinetics of ingenol mebutate gel under maximum use conditions in large treatment areas.
    The Journal of dermatological treatment, 2018, Volume: 29, Issue:1

    Topics: Administration, Cutaneous; Aged; Aged, 80 and over; Area Under Curve; Arm; Diterpenes; Face; Female;

2018
Safety and Efficacy of Escalating Doses of Ingenol Mebutate for Field Treatment of Actinic Keratosis on the Full Face, Full Balding Scalp, or Chest.
    Journal of drugs in dermatology : JDD, 2017, May-01, Volume: 16, Issue:5

    Topics: Administration, Topical; Aged; Diterpenes; Dose-Response Relationship, Drug; Face; Female; Humans; K

2017
Conventional vs. daylight photodynamic therapy for patients with actinic keratosis on face and scalp: 12-month follow-up results of a randomized, intra-individual comparative analysis.
    Journal of the European Academy of Dermatology and Venereology : JEADV, 2018, Volume: 32, Issue:4

    Topics: Aged; Aged, 80 and over; Face; Female; Follow-Up Studies; Humans; Keratosis, Actinic; Male; Middle A

2018
Calcipotriol as pretreatment prior to daylight-mediated photodynamic therapy in patients with actinic keratosis: A case series.
    Photodiagnosis and photodynamic therapy, 2018, Volume: 21

    Topics: Adult; Aged; Aminolevulinic Acid; Calcitriol; Dermatologic Agents; Face; Female; Humans; Keratosis,

2018
Protoporphyrin IX formation after application of methyl aminolevulinate on the face and scalp with and without prior curettage.
    Photodiagnosis and photodynamic therapy, 2018, Volume: 22

    Topics: Aged; Aged, 80 and over; Aminolevulinic Acid; Curettage; Face; Female; Humans; Keratosis, Actinic; M

2018
Short incubation fractional CO
    Journal of the European Academy of Dermatology and Venereology : JEADV, 2019, Volume: 33, Issue:1

    Topics: Administration, Cutaneous; Aged; Aged, 80 and over; Aminolevulinic Acid; Carcinoma, Basal Cell; Carc

2019
A randomized intraindividual comparative study of methyl-5-aminolaevulinate vs. 5-aminolaevulinic acid nanoemulsion (BF-200 ALA) in photodynamic therapy for actinic keratosis of the face and scalp.
    The British journal of dermatology, 2018, Volume: 179, Issue:6

    Topics: Administration, Cutaneous; Aged; Aminolevulinic Acid; Erythema; Face; Female; Humans; Keratosis, Act

2018
Photodynamic therapy for actinic keratosis of the forehead and scalp: a randomized, controlled, phase II clinical study evaluating the noninferiority of a new protocol involving irradiation with a light-emitting, fabric-based device (the Flexitheralight p
    The British journal of dermatology, 2019, Volume: 180, Issue:4

    Topics: Aged; Aged, 80 and over; Aminolevulinic Acid; Facial Dermatoses; Female; Forehead; Humans; Keratosis

2019
Single versus two-treatment schedule of methyl aminolevulinate daylight photodynamic therapy for actinic keratosis of the face and scalp: An intra-patient randomized trial.
    Photodiagnosis and photodynamic therapy, 2019, Volume: 27

    Topics: Aged; Aged, 80 and over; Aminolevulinic Acid; Drug Administration Schedule; Face; Female; Humans; Ke

2019
The European Medicines Agency approval of 5-aminolaevulinic acid (Ameluz) for the treatment of actinic keratosis of mild to moderate intensity on the face and scalp: summary of the scientific assessment of the Committee for Medicinal Products for Human Us
    The Journal of dermatological treatment, 2014, Volume: 25, Issue:5

    Topics: Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Aminolevulinic Acid; Face; Fema

2014
Imiquimod 2.5% and 3.75% for the treatment of actinic keratoses: two phase 3 multicenter, randomized, double-blind, placebo-controlled studies.
    Journal of drugs in dermatology : JDD, 2013, Volume: 12, Issue:11

    Topics: Adjuvants, Immunologic; Administration, Cutaneous; Aged; Aminoquinolines; Dose-Response Relationship

2013
Topical photodynamic therapy of actinic keratoses with 5-aminolevulinic acid: randomized controlled trial with six months follow-up.
    The Journal of dermatological treatment, 2014, Volume: 25, Issue:6

    Topics: Aminolevulinic Acid; Face; Follow-Up Studies; Humans; Keratosis, Actinic; Photochemotherapy; Photose

2014
Efficacy and safety of ingenol mebutate 0.015% gel 3 weeks after cryosurgery of actinic keratosis: 11-week results.
    Journal of drugs in dermatology : JDD, 2014, Volume: 13, Issue:2

    Topics: Administration, Cutaneous; Aged; Combined Modality Therapy; Cryosurgery; Dermatologic Agents; Diterp

2014
Imiquimod 2.5% and 3.75% for the treatment of actinic keratoses: two phase 3, multicenter, randomized, double-blind, placebo-controlled studies.
    Journal of drugs in dermatology : JDD, 2014, Volume: 13, Issue:2

    Topics: Adjuvants, Immunologic; Adult; Aminoquinolines; Dose-Response Relationship, Drug; Double-Blind Metho

2014
Long-term sustained lesion clearance from Lmax with imiquimod 3.75%, a new field-directed treatment for actinic keratosis.
    Journal of the European Academy of Dermatology and Venereology : JEADV, 2015, Volume: 29, Issue:9

    Topics: Adjuvants, Immunologic; Administration, Topical; Aged; Aminoquinolines; Delayed-Action Preparations;

2015
Efficacy of imiquimod 3.75% from Lmax according to the number of actinic keratosis lesions.
    Journal of the European Academy of Dermatology and Venereology : JEADV, 2015, Volume: 29, Issue:12

    Topics: Aged; Aminoquinolines; Antineoplastic Agents; Double-Blind Method; Face; Facial Dermatoses; Female;

2015
Comparing cold-air analgesia, systemically administered analgesia and scalp nerve blocks for pain management during photodynamic therapy for actinic keratosis of the scalp presenting as field cancerization: a randomized controlled trial.
    The British journal of dermatology, 2015, Volume: 173, Issue:1

    Topics: Administration, Oral; Aged; Aminolevulinic Acid; Analgesia; Analgesics, Opioid; Analysis of Variance

2015
A Randomized Split-Face Clinical Trial of Photodynamic Therapy with Methyl Aminolevulinate versus Ingenol Mebutate Gel for the Treatment of Multiple Actinic Keratoses of the Face and Scalp.
    Dermatology (Basel, Switzerland), 2016, Volume: 232, Issue:4

    Topics: Administration, Topical; Aged; Aged, 80 and over; Aminolevulinic Acid; Diterpenes; Face; Facial Derm

2016
Variables in Cryosurgery Technique Associated With Clearance of Actinic Keratosis.
    Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.], 2017, Volume: 43, Issue:3

    Topics: Administration, Cutaneous; Adolescent; Adult; Cryosurgery; Dermatologic Agents; Diterpenes; Face; Ge

2017
PEP005 (ingenol mebutate) gel, a novel agent for the treatment of actinic keratosis: results of a randomized, double-blind, vehicle-controlled, multicentre, phase IIa study.
    The Australasian journal of dermatology, 2009, Volume: 50, Issue:1

    Topics: Administration, Cutaneous; Adult; Aged; Aged, 80 and over; Antineoplastic Agents, Phytogenic; Arm; A

2009
Skin cancer: preventive photodynamic therapy in patients with face and scalp cancerization. A randomized placebo-controlled study.
    The British journal of dermatology, 2010, Volume: 162, Issue:1

    Topics: Aged; Aged, 80 and over; Aminolevulinic Acid; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Facia

2010
Topical treatment of actinic keratoses with piroxicam 1% gel: a preliminary open-label study utilizing a new clinical score.
    American journal of clinical dermatology, 2010, Volume: 11, Issue:1

    Topics: Administration, Cutaneous; Aged; Aged, 80 and over; Anticarcinogenic Agents; Cyclooxygenase 1; Cyclo

2010
Imiquimod 2.5% and 3.75% for the treatment of actinic keratoses: results of two placebo-controlled studies of daily application to the face and balding scalp for two 3-week cycles.
    Journal of the American Academy of Dermatology, 2010, Volume: 62, Issue:4

    Topics: Adjuvants, Immunologic; Administration, Topical; Adult; Aged; Aged, 80 and over; Aminoquinolines; Do

2010
Imiquimod 2.5% and 3.75% for the treatment of actinic keratoses: results of two placebo-controlled studies of daily application to the face and balding scalp for two 2-week cycles.
    Journal of the American Academy of Dermatology, 2010, Volume: 62, Issue:4

    Topics: Adjuvants, Immunologic; Administration, Topical; Adult; Aged; Aged, 80 and over; Aminoquinolines; Do

2010
Imiquimod 2.5% and 3.75% for the treatment of actinic keratoses: results of two placebo-controlled studies of daily application to the face and balding scalp for two 2-week cycles.
    Journal of the American Academy of Dermatology, 2010, Volume: 62, Issue:4

    Topics: Adjuvants, Immunologic; Administration, Topical; Adult; Aged; Aged, 80 and over; Aminoquinolines; Do

2010
Imiquimod 2.5% and 3.75% for the treatment of actinic keratoses: results of two placebo-controlled studies of daily application to the face and balding scalp for two 2-week cycles.
    Journal of the American Academy of Dermatology, 2010, Volume: 62, Issue:4

    Topics: Adjuvants, Immunologic; Administration, Topical; Adult; Aged; Aged, 80 and over; Aminoquinolines; Do

2010
Imiquimod 2.5% and 3.75% for the treatment of actinic keratoses: results of two placebo-controlled studies of daily application to the face and balding scalp for two 2-week cycles.
    Journal of the American Academy of Dermatology, 2010, Volume: 62, Issue:4

    Topics: Adjuvants, Immunologic; Administration, Topical; Adult; Aged; Aged, 80 and over; Aminoquinolines; Do

2010
Pharmacokinetics of imiquimod 3.75% cream applied daily for 3 weeks to actinic keratoses on the face and/or balding scalp.
    Archives of dermatological research, 2010, Volume: 302, Issue:7

    Topics: Aged; Aged, 80 and over; Alopecia; Aminoquinolines; Face; Female; Half-Life; Humans; Imiquimod; Kera

2010
Complete clearance is sustained for at least 12 months after treatment of actinic keratoses of the face or balding scalp via daily dosing with imiquimod 3.75% or 2.5% cream.
    Journal of drugs in dermatology : JDD, 2011, Volume: 10, Issue:2

    Topics: Adult; Aminoquinolines; Double-Blind Method; Drug Administration Schedule; Face; Humans; Imiquimod;

2011
Single vs. fractionated photodynamic therapy for face and scalp actinic keratoses: a randomized, intraindividual comparison trial with 12-month follow-up.
    Journal of the European Academy of Dermatology and Venereology : JEADV, 2012, Volume: 26, Issue:1

    Topics: Aged; Aminolevulinic Acid; Female; Humans; Keratosis, Actinic; Male; Middle Aged; Photochemotherapy;

2012
Treatment of actinic keratoses and photodamage with non-contact fractional 1540-nm laser quasi-ablation: an ex vivo and clinical evaluation.
    Lasers in medical science, 2013, Volume: 28, Issue:2

    Topics: Aged; Cicatrix; Edema; Erythema; Face; Female; Humans; Keratosis, Actinic; Laser Therapy; Lasers, So

2013

Other Studies

59 other studies available for salicylic acid and Keratosis, Actinic

ArticleYear
Early clinical response to 5-fluorouracil 0.5% and salicylic acid 10% topical solution in the treatment of actinic keratoses of the head: an observational study.
    The Journal of dermatological treatment, 2022, Volume: 33, Issue:5

    Topics: Fluorouracil; Humans; Keratosis, Actinic; Prospective Studies; Salicylic Acid; Treatment Outcome

2022
Treatment monitoring of 5-fluorouracil 0.5%/salicylic acid 10% lesion-directed therapy for actinic keratosis using dermoscopy and in-vivo reflectance confocal microscopy.
    Dermatologic therapy, 2020, Volume: 33, Issue:4

    Topics: Dermoscopy; Fluorouracil; Humans; Keratosis, Actinic; Microscopy, Confocal; Salicylic Acid

2020
0.5% 5-Fluorouracil/10% Salicylic Acid for the Treatment of Distal Actinic Keratoses Under Daily Practice Conditions
    Journal of drugs in dermatology : JDD, 2019, Mar-01, Volume: 18, Issue:3

    Topics: Administration, Cutaneous; Aged; Aged, 80 and over; Dermatologic Agents; Drug Combinations; Extremit

2019
Cost-effectiveness analysis of 5-fluorouracil 0.5%/salicylic acid 10% in the treatment of actinic keratosis in Spain.
    Expert review of pharmacoeconomics & outcomes research, 2015, Volume: 15, Issue:3

    Topics: Antimetabolites, Antineoplastic; Cost-Benefit Analysis; Cryotherapy; Decision Support Techniques; Dr

2015
In vivo reflectance confocal microscopy characterization of field-directed 5-fluorouracil 0.5%/salicylic acid 10% in actinic keratosis.
    Dermatology (Basel, Switzerland), 2015, Volume: 230, Issue:3

    Topics: Administration, Topical; Aged; Aged, 80 and over; Antimetabolites, Antineoplastic; Dermatologic Agen

2015
A cost-utility analysis of ingenol mebutate gel for the treatment of actinic keratosis: a Scottish perspective.
    The European journal of health economics : HEPAC : health economics in prevention and care, 2016, Volume: 17, Issue:3

    Topics: Cost-Benefit Analysis; Cryotherapy; Diclofenac; Diterpenes; Dose-Response Relationship, Drug; Fluoro

2016
Retrospective analysis evaluating the effect of a keratolytic and physical pretreatment with salicylic acid, urea and curettage on the efficacy and safety of photodynamic therapy of actinic keratoses with methylaminolaevulinate.
    Journal of the European Academy of Dermatology and Venereology : JEADV, 2016, Volume: 30, Issue:4

    Topics: Aged; Aminolevulinic Acid; Female; Humans; Keratosis, Actinic; Male; Middle Aged; Photochemotherapy;

2016
Treatment monitoring of 0.5% 5-fluorouracil and 10% salicylic acid in clinical and subclinical actinic keratoses with the combination of optical coherence tomography and reflectance confocal microscopy.
    Journal of the European Academy of Dermatology and Venereology : JEADV, 2016, Volume: 30, Issue:2

    Topics: Administration, Topical; Dermoscopy; Drug Administration Schedule; Drug Therapy, Combination; Female

2016
Actikerall™ (5-Fluorouracil 0.5% and Salicylic Acid 10%) Topical Solution for Patient-directed Treatment of Actinic Keratoses.
    Skin therapy letter, 2016, Volume: 21, Issue:3

    Topics: Administration, Topical; Clinical Trials as Topic; Drug Combinations; Fluorouracil; Humans; Keratosi

2016
Low-dose 5-fluorouracil in combination with salicylic acid for the treatment of actinic keratoses on the hands and/or forearms - results of a non-interventional study.
    Journal of the European Academy of Dermatology and Venereology : JEADV, 2017, Volume: 31, Issue:3

    Topics: Adult; Aged; Aged, 80 and over; Antimetabolites, Antineoplastic; Drug Combinations; Female; Fluorour

2017
The cost-effectiveness of 5-FU-SA in the treatment of actinic keratoses of the face and scalp in the UK secondary care setting.
    Journal of medical economics, 2017, Volume: 20, Issue:3

    Topics: Aged; Cost-Benefit Analysis; Face; Humans; Keratolytic Agents; Keratosis, Actinic; Male; Salicylic A

2017
[Effect of sodium para-amino-salicylate on disorders of keratinization].
    Journal de medecine de Lyon, 1950, Aug-20, Volume: 31, Issue:735

    Topics: Amino Acids; Aminosalicylic Acid; Humans; Keratosis; Keratosis, Actinic; Salicylic Acid; Sodium; Sod

1950
Encountering Ethylene Vinyl Alcohol in Dimethyl Sulfoxide Embolization Material During Electrodesiccation and Curettage.
    Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.], 2021, 10-01, Volume: 47, Issue:10

    Topics: Aged, 80 and over; Animals; Arteriovenous Fistula; Biopsy; Carcinoma in Situ; Curettage; Dimethyl Su

2021
No room for pain: A prospective study showing effective and nearly pain-free treatment of actinic keratosis with simulated daylight photodynamic therapy (SDL-PDT) using the IndoorLux® System in combination with BF-200 ALA (Ameluz®).
    Photodiagnosis and photodynamic therapy, 2022, Volume: 37

    Topics: Aminolevulinic Acid; Humans; Keratosis, Actinic; Pain; Photochemotherapy; Photosensitizing Agents; P

2022
Efficacy and safety of a thermal fractional skin rejuvenation system (Tixel) for the treatment of facial and/or scalp actinic keratoses.
    Lasers in medical science, 2022, Volume: 37, Issue:7

    Topics: Humans; Keratosis, Actinic; Prospective Studies; Rejuvenation; Scalp; Skin; Treatment Outcome

2022
Fully home-based methyl aminolevulinate daylight photodynamic therapy for actinic keratosis of the face or scalp: A real life open study.
    Dermatologic therapy, 2022, Volume: 35, Issue:11

    Topics: Aged; Aminolevulinic Acid; Female; Humans; Keratosis, Actinic; Male; Photochemotherapy; Photosensiti

2022
IGF1 synthesis after CO
    Lasers in surgery and medicine, 2023, Volume: 55, Issue:7

    Topics: Aged; Carbon Dioxide; Carcinoma, Squamous Cell; Humans; Insulin-Like Growth Factor I; Keratosis, Act

2023
Association between calcium channel blockers and the severity of actinic keratosis on face and scalp: a cross-sectional study.
    International journal of dermatology, 2023, Volume: 62, Issue:12

    Topics: Calcium Channel Blockers; Cross-Sectional Studies; Humans; Keratosis, Actinic; Male; Scalp; Skin Neo

2023
[Multiple cutaneous squamous cell carcinoma after treatment with ingenol mebutate].
    Annales de dermatologie et de venereologie, 2019, Volume: 146, Issue:12

    Topics: Aged, 80 and over; Antineoplastic Agents; Carcinoma, Squamous Cell; Cell Transformation, Neoplastic;

2019
Iceberg sign in actinic keratosis neglecta caused by toning shampoo for blonde and white hair.
    International journal of dermatology, 2020, Volume: 59, Issue:3

    Topics: Biopsy; Dermoscopy; Hair Preparations; Humans; Keratosis, Actinic; Scalp; Skin

2020
Combined daylight and conventional photodynamic therapy with 5-aminolaevulinic acid nanoemulsion (BF-200 ALA) for actinic keratosis of the face and scalp: a new and efficient approach.
    Archives of dermatological research, 2020, Volume: 312, Issue:9

    Topics: Aged; Aged, 80 and over; Aminolevulinic Acid; Face; Female; Humans; Keratosis, Actinic; Light; Male;

2020
Surgical approach to the management of field cancerization: Own experience.
    Dermatologic therapy, 2020, Volume: 33, Issue:4

    Topics: Carcinoma, Squamous Cell; Humans; Keratosis, Actinic; Scalp; Skin; Skin Neoplasms

2020
Clinical, histopathological and immunohistochemical evaluation of daylight photodynamic therapy in the treatment of field cancerization: a study of 30 cases.
    The Journal of dermatological treatment, 2022, Volume: 33, Issue:2

    Topics: Adult; Aminolevulinic Acid; Humans; Keratosis, Actinic; Photochemotherapy; Photosensitizing Agents;

2022
Occurrence of Acute Cerebellar Syndrome After Topical Application of Fluorouracil.
    JAMA dermatology, 2017, 08-01, Volume: 153, Issue:8

    Topics: Acute Disease; Administration, Topical; Cerebellar Diseases; Fluorouracil; Humans; Immunosuppressive

2017
A Novel Actinic Keratosis Field Assessment Scale for Grading Actinic Keratosis Disease Severity.
    Acta dermato-venereologica, 2017, Oct-02, Volume: 97, Issue:9

    Topics: Face; Humans; Keratosis; Keratosis, Actinic; Photography; Reproducibility of Results; Scalp; Severit

2017
Field treatment of actinic keratosis on the scalp.
    The British journal of dermatology, 2017, Volume: 176, Issue:6

    Topics: Humans; Keratosis; Keratosis, Actinic; Scalp; Scalp Dermatoses

2017
Ingenol mebutate for the treatment of actinic keratosis: effectiveness and safety in 246 patients treated in real-life clinical practice.
    The Journal of dermatological treatment, 2018, Volume: 29, Issue:4

    Topics: Administration, Topical; Adult; Age Factors; Aged; Aged, 80 and over; Diterpenes; Face; Female; Gels

2018
Response to 'Phase IV head-to-head randomized controlled trial comparing ingenol mebutate 0·015% gel with diclofenac sodium 3% gel for the treatment of actinic keratosis on the face or scalp'.
    The British journal of dermatology, 2018, Volume: 178, Issue:3

    Topics: Diclofenac; Diterpenes; Humans; Keratosis, Actinic; Scalp

2018
Response to 'Phase IV head-to-head randomized controlled trial comparing ingenol mebutate 0·015% gel with diclofenac sodium 3% gel for the treatment of actinic keratosis on the face or scalp': reply from the authors.
    The British journal of dermatology, 2018, Volume: 178, Issue:3

    Topics: Diclofenac; Diterpenes; Humans; Keratosis, Actinic; Scalp

2018
Treating actinic keratosis: assessment of effectiveness, discomfort, costs and follow-up.
    The British journal of dermatology, 2018, Volume: 178, Issue:2

    Topics: Diclofenac; Diterpenes; Follow-Up Studies; Humans; Keratosis, Actinic; Scalp

2018
Histological intralesional heterogeneity of actinic keratoses relates to field cancerization.
    Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG, 2018, Volume: 16, Issue:10

    Topics: Aged; Aged, 80 and over; Biopsy; Cell Proliferation; Cell Transformation, Neoplastic; Facial Neoplas

2018
Two cases of erosive pustular dermatosis of the scalp occurring after topical 3.75% imiquimod for actinic keratoses.
    Dermatologic therapy, 2019, Volume: 32, Issue:1

    Topics: Administration, Cutaneous; Aged; Aged, 80 and over; Clobetasol; Dermatologic Agents; Drug Eruptions;

2019
Non-invasive monitoring of subclinical and clinical actinic keratosis of face and scalp under topical treatment with ingenol mebutate gel 150 mcg/g by means of reflectance confocal microscopy and optical coherence tomography: New perspectives and comparis
    Journal of biophotonics, 2019, Volume: 12, Issue:7

    Topics: Administration, Topical; Aged; Aged, 80 and over; Diterpenes; Dose-Response Relationship, Drug; Face

2019
Daylight photodynamic therapy in 25 patients with actinic keratosis and evaluation of efficacy by confocal microscopy.
    Photodiagnosis and photodynamic therapy, 2019, Volume: 25

    Topics: Aged; Aged, 80 and over; Aminolevulinic Acid; Face; Female; Humans; Keratosis, Actinic; Male; Micros

2019
Efficacy of topical imiquimod 3.75% in the treatment of actinic keratosis of the scalp in immunosuppressed patients: our case series.
    The Journal of dermatological treatment, 2020, Volume: 31, Issue:3

    Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Erythema; Female; Humans; Imiquimod; Immunocompromis

2020
Taking daylight-PDT home.
    Journal of the European Academy of Dermatology and Venereology : JEADV, 2019, Volume: 33, Issue:4

    Topics: Aminolevulinic Acid; Germany; Humans; Keratosis, Actinic; Photochemotherapy; Scalp

2019
Come in from the cold - laser fabric photodynamic therapy offers an alternative to seasonal daylight therapy.
    The British journal of dermatology, 2019, Volume: 180, Issue:4

    Topics: Aminolevulinic Acid; Forehead; Humans; Keratosis, Actinic; Photochemotherapy; Photosensitizing Agent

2019
The '5R + R' Rule: A simple and comprehensive method for diagnosis of actinic keratosis.
    Sultan Qaboos University medical journal, 2019, Volume: 19, Issue:1

    Topics: Education, Medical, Continuing; Humans; Keratosis, Actinic; Scalp

2019
Ablative Fractional Laser-assisted Daylight Photodynamic Therapy for Actinic Keratoses of the Scalp and Forehead in Organ Transplant Recipients: A Pilot Study.
    Acta dermato-venereologica, 2019, Oct-01, Volume: 99, Issue:11

    Topics: Aged; Aminolevulinic Acid; Female; Forehead; Humans; Keratosis, Actinic; Male; Middle Aged; Photoche

2019
5% fluorouracil chemowraps in the management of widespread lower leg solar keratoses and squamous cell carcinoma.
    The Australasian journal of dermatology, 2013, Volume: 54, Issue:4

    Topics: Administration, Cutaneous; Antimetabolites, Antineoplastic; Bandages; Carcinoma, Squamous Cell; Fluo

2013
Efficacy of a photolyase-based device in the treatment of cancerization field in patients with actinic keratosis and non-melanoma skin cancer.
    Giornale italiano di dermatologia e venereologia : organo ufficiale, Societa italiana di dermatologia e sifilografia, 2013, Volume: 148, Issue:6

    Topics: Aged; Anticarcinogenic Agents; Carcinoma, Squamous Cell; Cell Transformation, Neoplastic; Deoxyribod

2013
Monitoring treatment of field cancerisation with 3% diclofenac sodium 2.5% hyaluronic acid by reflectance confocal microscopy: a histologic correlation.
    Acta dermato-venereologica, 2015, Volume: 95, Issue:1

    Topics: Administration, Cutaneous; Anti-Inflammatory Agents, Non-Steroidal; Biopsy; Diclofenac; Drug Therapy

2015
Comparative study of trichloroacetic acid vs. photodynamic therapy with topical 5-aminolevulinic acid for actinic keratosis of the scalp.
    Photodermatology, photoimmunology & photomedicine, 2015, Volume: 31, Issue:5

    Topics: Administration, Topical; Aged, 80 and over; Aminolevulinic Acid; Child; Humans; Keratosis, Actinic;

2015
Ablative fractional laser intensifies treatment outcome of scalp actinic keratoses with ingenol mebutate: a case report.
    Journal of the European Academy of Dermatology and Venereology : JEADV, 2016, Volume: 30, Issue:5

    Topics: Diterpenes; Humans; Keratosis, Actinic; Laser Therapy; Male; Scalp; Treatment Outcome

2016
Effect of Field Treatment of Actinic Keratosis With Ingenol Mebutate Gel on the Identification of Lesions for Biopsy.
    Journal of drugs in dermatology : JDD, 2015, Volume: 14, Issue:8

    Topics: Aged; Antineoplastic Agents; Biopsy; Carcinoma, Squamous Cell; Combined Modality Therapy; Cryosurger

2015
Clinical experience of imiquimod 3.75% for actinic keratosis: results from a case series.
    Giornale italiano di dermatologia e venereologia : organo ufficiale, Societa italiana di dermatologia e sifilografia, 2018, Volume: 153, Issue:3

    Topics: Adjuvants, Immunologic; Aged; Aged, 80 and over; Aminoquinolines; Cohort Studies; Dermatologic Agent

2018
Sequential Curettage, 5-Fluorouracil, and Photodynamic Therapy for Field Cancerization of the Scalp and Face in Solid Organ Transplant Recipients.
    Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.], 2016, Volume: 42 Suppl 1

    Topics: Antimetabolites, Antineoplastic; Carcinoma in Situ; Carcinoma, Squamous Cell; Combined Modality Ther

2016
Scalp melanoma: Distinctive high risk clinical and histological features.
    The Australasian journal of dermatology, 2017, Volume: 58, Issue:3

    Topics: Adult; Age Factors; Aged; Aged, 80 and over; Ear Neoplasms; Facial Neoplasms; Female; Head and Neck

2017
Efficacy and Safety of Imiquimod 3.75% from Lmax in Actinic Keratosis According to Fitzpatrick Skin Type.
    Journal of drugs in dermatology : JDD, 2016, Volume: 15, Issue:3

    Topics: Adjuvants, Immunologic; Administration, Topical; Aged; Aminoquinolines; Double-Blind Method; Face; F

2016
Real-life efficacy and safety of ingenol mebutate for the treatment of actinic keratosis of the face and scalp: A single arm retrospective study.
    The Journal of dermatological treatment, 2016, Volume: 27, Issue:6

    Topics: Administration, Cutaneous; Adult; Diterpenes; Face; Female; Humans; Keratosis, Actinic; Male; Retros

2016
A network meta-analysis of the relative efficacy of treatments for actinic keratosis of the face or scalp in Europe: response to comments from Prof Dirschka.
    Journal of the European Academy of Dermatology and Venereology : JEADV, 2017, Volume: 31, Issue:4

    Topics: Europe; Face; Humans; Keratosis, Actinic; Network Meta-Analysis; Photochemotherapy; Scalp; Treatment

2017
Response to: a network meta-analysis of the relative efficacy of treatments for actinic keratosis of the face or scalp in Europe.
    Journal of the European Academy of Dermatology and Venereology : JEADV, 2017, Volume: 31, Issue:3

    Topics: Europe; Face; Humans; Keratosis, Actinic; Network Meta-Analysis; Scalp

2017
Ingenol Mebutate 500 μg for Treatment of the Scalp in Refractory Field Cancerization.
    Dermatology (Basel, Switzerland), 2016, Volume: 232 Suppl 1

    Topics: Aged; Antineoplastic Agents; Carcinogenesis; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Diterp

2016
Photodynamic Therapy Effectively Treats Actinic Keratoses Without Pre-Illumination Incubation Time.
    Journal of drugs in dermatology : JDD, 2017, Mar-01, Volume: 16, Issue:3

    Topics: Aminolevulinic Acid; Face; Humans; Keratosis, Actinic; Male; Middle Aged; Pain; Photochemotherapy; P

2017
Intensified inflammatory reaction of actinic keratoses after single application of topical 5-fluorouracil in a patient treated with nilotinib for chronic myeloid leukemia.
    Dermatology (Basel, Switzerland), 2009, Volume: 219, Issue:4

    Topics: Administration, Cutaneous; Aged; Antineoplastic Agents; Dermatologic Agents; Drug Therapy, Combinati

2009
Scalp problems.
    The Practitioner, 2010, Volume: 254, Issue:1726

    Topics: Alopecia; Carcinoma, Basal Cell; Humans; Keratosis, Actinic; Medical Illustration; Photography; Psor

2010
[Malignant skin diseases in organ transplant patients].
    Praxis, 2012, Jan-18, Volume: 101, Issue:2

    Topics: Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Diagnosis, Differential; Humans; Immunosuppressive

2012
[COMBINED THERAPY OF CORNU CUTANEUM OF THE SCALP].
    Meditsinskaia radiologiia, 1964, Volume: 9

    Topics: Cornus; Humans; Keratosis; Keratosis, Actinic; Radiotherapy; Scalp; Scalp Dermatoses; Skin Neoplasms

1964
Dermabrasion of extensive keratotic lesions of the forehead and scalp.
    Plastic and reconstructive surgery and the transplantation bulletin, 1962, Volume: 30

    Topics: Dermabrasion; Dermatologic Surgical Procedures; Disease; Face; Forehead; Humans; Keratosis; Keratosi

1962