salicylic acid has been researched along with Fibrosis in 86 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).
Fibrosis: Any pathological condition where fibrous connective tissue invades any organ, usually as a consequence of inflammation or other injury.
| Excerpt | Relevance | Reference |
|---|---|---|
| "Dutasteride has been proposed as an effective therapy for frontal fibrosing alopecia (FFA)." | 8.02 | Effectiveness of dutasteride in a large series of patients with frontal fibrosing alopecia in real clinical practice. ( Hermosa-Gelbard, Á; Jaén-Olasolo, P; Moreno-Arrones, ÓM; Pindado-Ortega, C; Rodrigues-Barata, AR; Saceda-Corralo, D; Vañó-Galván, S, 2021) |
| "Patterns of fibrosis highlighted by elastin staining in primary cicatricial alopecia appear to be disease specific." | 7.79 | Elastin staining patterns in primary cicatricial alopecia. ( Barr, KL; Fung, MA; Konia, TH; Mirmirani, P; Ratnarathorn, M; Sharon, VR, 2013) |
| "While consensus is that androgenic alopecia is genetic and androgen-mediated by dihydrotestosterone, questions remain regarding dihydrotestosterone's exact role in androgenic alopecia onset." | 5.48 | A hypothetical pathogenesis model for androgenic alopecia: clarifying the dihydrotestosterone paradox and rate-limiting recovery factors. ( English, RS, 2018) |
| "Dutasteride has been proposed as an effective therapy for frontal fibrosing alopecia (FFA)." | 4.02 | Effectiveness of dutasteride in a large series of patients with frontal fibrosing alopecia in real clinical practice. ( Hermosa-Gelbard, Á; Jaén-Olasolo, P; Moreno-Arrones, ÓM; Pindado-Ortega, C; Rodrigues-Barata, AR; Saceda-Corralo, D; Vañó-Galván, S, 2021) |
| "Patterns of fibrosis highlighted by elastin staining in primary cicatricial alopecia appear to be disease specific." | 3.79 | Elastin staining patterns in primary cicatricial alopecia. ( Barr, KL; Fung, MA; Konia, TH; Mirmirani, P; Ratnarathorn, M; Sharon, VR, 2013) |
| "Analyzing other scarring diseases (lichen planopilaris, fibrotic kidney disease and scleroderma) may help to clarify the mechanism of scarring in CCCA." | 2.66 | A proposed mechanism for central centrifugal cicatricial alopecia. ( Alexander, T; Beamer, V; McMichael, A; Subash, J, 2020) |
| "The result is a permanent scarring hair loss accentuated at the front hairline with backward movement towards the neck mostly accompanied by a typical loss of the eyebrows." | 2.58 | [Postmenopausal lichen planopilaris also known as fibrosing frontotemporal alopecia Kossard : An evidence-oriented practical guide to treatment from the University of the Saarland, Hair Research Center of the Dr. Rolf M. Schwiete Foundation]. ( Christmann, R; Lehr, CM; Loretz, B; Mawlood, D; Müller, C; Reichrath, J; Schäfer, U; Schilling, L; Thomas, C; Vogt, T, 2018) |
| "Folliculitis keloidalis is a cicatricial alopecia with a mixed inflammatory infiltrate." | 2.52 | Primary scarring alopecias. ( Ioannides, D; Rigopoulos, D; Stamatios, G, 2015) |
| "Frontal fibrosing alopecia is a condition of unknown origin, histologically similar to classic lichen planopilaris and generally observed in postmenopausal women with alopecia of the frontal-temporal hairline." | 1.51 | Clinical-histopathological profile of the frontal fibrosing alopecia: a retrospective study of 16 cases of a university hospital. ( Andrade, LCDS; Paula, NÁO; Quintella, DC; Secchin, P; Sodré, CT, 2019) |
| "Sixty biopsies from androgenetic alopecia served as controls." | 1.51 | Adipose Infiltration of the Dermis, Involving the Arrector Pili Muscle, and Dermal Displacement of Eccrine Sweat Coils: New Histologic Observations in Frontal Fibrosing Alopecia. ( Castillo, D; Miteva, M; Sabiq, S, 2019) |
| "While consensus is that androgenic alopecia is genetic and androgen-mediated by dihydrotestosterone, questions remain regarding dihydrotestosterone's exact role in androgenic alopecia onset." | 1.48 | A hypothetical pathogenesis model for androgenic alopecia: clarifying the dihydrotestosterone paradox and rate-limiting recovery factors. ( English, RS, 2018) |
| "Frontal fibrosing alopecia is characterized by frontotemporal hairline recession and eybrow loss." | 1.48 | Coexistence of chronic cutaneous lupus erythematosus and frontal fibrosing alopecia. ( Enokihara, MMSES; Nascimento, LLD; Vasconcellos, MRA, 2018) |
| "Frontal fibrosing alopecia is a scarring alopecia thatis characterized by recession of the frontotemporalhairline with the frequent loss of eyebrows." | 1.43 | Frontal fibrosing alopecia in a 46-year-old man. ( Callahan, S; Kim, RH; Meehan, SA; Stein, J; White, F, 2016) |
| "Alopecia is the fifth most common dermatologic diagnosis in African-American patients." | 1.39 | Prospective histologic examinations in patients who practice traumatic hairstyling. ( Mehregan, DM; Uhlenhake, EE, 2013) |
| "FFA is an increasingly common form of scarring hair loss, but the origin remains unknown." | 1.39 | Frontal fibrosing alopecia: a retrospective review of 19 patients seen at Duke University. ( Bazakas, A; Ladizinski, B; Olsen, EA; Selim, MA, 2013) |
| "Atypical fibroxanthoma (AFX) with prominent fibrosis, sclerosis and hyalinization, and near-total tumor regression is rare." | 1.36 | The histopathologic spectrum of regression in atypical fibroxanthoma. ( Calonje, JE; Robson, A; Stefanato, CM, 2010) |
| "However, eyebrow loss and hair loss in other body sites may also occur; this has been documented clinically, but rarely histopathologically." | 1.36 | Expanding the spectrum of frontal fibrosing alopecia: a unifying concept. ( Bashir, SJ; Chew, AL; Fenton, DA; Stefanato, CM; Wain, EM, 2010) |
| "All had frontotemporal recession with scarring." | 1.35 | Frontal fibrosing alopecia: clinical presentations and prognosis. ( Messenger, AG; Tan, KT, 2009) |
| "Androgenetic alopecia is a common cosmetic hair disorder, resulting from interplay of genetic, endocrine, and aging factors leading to a patterned follicular miniaturization." | 1.35 | Androgenetic alopecia in males: a histopathological and ultrastructural study. ( Abdel-Wahab, H; Attia, S; El-Domyati, M; Saleh, F, 2009) |
| "Female pattern hair loss (FPHL) is a common hair disorder of the central scalp." | 1.33 | Female pattern hair loss and its relationship to permanent/cicatricial alopecia: a new perspective. ( Olsen, EA, 2005) |
| "Buschke-Ollendorff syndrome is an association of connective tissue nevi and osteopoikilosis that usually appears in the first decades of life." | 1.28 | Buschke-Ollendorff syndrome of the scalp: histologic and ultrastructural findings. ( Ben-David, E; David, M; Rothem, A; Sandbank, M; Trattner, A, 1991) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 8 (9.30) | 18.2507 |
| 2000's | 14 (16.28) | 29.6817 |
| 2010's | 44 (51.16) | 24.3611 |
| 2020's | 20 (23.26) | 2.80 |
| Authors | Studies |
|---|---|
| Samrao, A | 1 |
| Lyon, L | 1 |
| Mirmirani, P | 7 |
| Blume-Peytavi, U | 1 |
| Hillmann, K | 1 |
| Constantinou, A | 1 |
| Vogt, A | 1 |
| Miteva, M | 5 |
| Nadji, M | 1 |
| Billero, V | 1 |
| LaSenna, C | 1 |
| Nattkemper, L | 1 |
| Romanelli, P | 2 |
| Pathoulas, JT | 3 |
| Flanagan, KE | 3 |
| Walker, CJ | 3 |
| Collins, MS | 3 |
| Ali, S | 3 |
| Pupo Wiss, IM | 3 |
| Cotsarelis, G | 3 |
| Milbar, H | 3 |
| Huang, K | 3 |
| Mostaghimi, A | 3 |
| Scott, D | 3 |
| Han, JJ | 3 |
| Lee, KJ | 3 |
| Hordinsky, MK | 5 |
| Farah, RS | 4 |
| Bellefeuille, G | 3 |
| Raymond, O | 3 |
| Bergfeld, W | 5 |
| Ranasinghe, G | 3 |
| Shapiro, J | 4 |
| Lo Sicco, KI | 3 |
| Gutierrez, D | 3 |
| Ko, J | 3 |
| Mesinkovska, N | 3 |
| Yale, KL | 3 |
| Goldberg, LJ | 3 |
| Tosti, A | 10 |
| Gwillim, EC | 3 |
| Goh, C | 3 |
| Senna, MM | 3 |
| Karim, N | 1 |
| Durbin-Johnson, BP | 1 |
| Rocke, DM | 1 |
| Salemi, M | 1 |
| Phinney, BS | 1 |
| Rice, RH | 1 |
| Valdebran, M | 1 |
| Mo, J | 1 |
| Elston, DM | 1 |
| Doan, L | 1 |
| Suchonwanit, P | 1 |
| Pakornphadungsit, K | 1 |
| Leerunyakul, K | 1 |
| Khunkhet, S | 1 |
| Sriphojanart, T | 1 |
| Rojhirunsakool, S | 1 |
| Secchin, P | 1 |
| Quintella, DC | 1 |
| Paula, NÁO | 1 |
| Andrade, LCDS | 1 |
| Sodré, CT | 1 |
| Griggs, J | 1 |
| Trüeb, RM | 2 |
| Gavazzoni Dias, MFR | 1 |
| Hordinsky, M | 1 |
| Trindade de Carvalho, L | 1 |
| Meah, N | 1 |
| Wall, D | 1 |
| Sinclair, R | 2 |
| Pindado-Ortega, C | 1 |
| Saceda-Corralo, D | 1 |
| Moreno-Arrones, ÓM | 1 |
| Rodrigues-Barata, AR | 1 |
| Hermosa-Gelbard, Á | 1 |
| Jaén-Olasolo, P | 1 |
| Vañó-Galván, S | 1 |
| Nemazee, L | 1 |
| Harries, M | 2 |
| Morandi Stumpf, MA | 1 |
| do Rocio Valenga Baroni, E | 1 |
| Schafranski, MD | 1 |
| Porriño-Bustamante, ML | 1 |
| Fernández-Pugnaire, MA | 1 |
| Castellote-Caballero, L | 1 |
| Arias-Santiago, S | 1 |
| Heymann, WR | 1 |
| Dubin, C | 1 |
| Glickman, JW | 1 |
| Del Duca, E | 1 |
| Chennareddy, S | 1 |
| Han, J | 1 |
| Dahabreh, D | 1 |
| Estrada, YD | 1 |
| Zhang, N | 1 |
| Kimmel, GW | 1 |
| Singer, G | 1 |
| Chowdhury, M | 1 |
| Zheng, AY | 1 |
| Angelov, M | 1 |
| Gay-Mimbrera, J | 1 |
| Ruano Ruiz, J | 1 |
| Krueger, JG | 1 |
| Pavel, AB | 1 |
| Guttman-Yassky, E | 1 |
| Altemir, A | 1 |
| Lobato-Berezo, A | 2 |
| Pujol, RM | 2 |
| White, F | 1 |
| Callahan, S | 1 |
| Kim, RH | 1 |
| Meehan, SA | 1 |
| Stein, J | 1 |
| Kruglikov, IL | 1 |
| Scherer, PE | 1 |
| Lis-Święty, A | 1 |
| Miziołek, B | 1 |
| Ranosz-Janicka, I | 1 |
| Bierzyńska-Macyszyn, G | 1 |
| Brzezińska-Wcisło, L | 1 |
| Liu, YS | 1 |
| Jee, SH | 1 |
| Chan, JL | 1 |
| Vazquez-Herrera, NE | 1 |
| Eber, AE | 1 |
| Martinez-Velasco, MA | 1 |
| Perper, M | 1 |
| Cervantes, J | 1 |
| Verne, SH | 1 |
| Magno, RJ | 1 |
| Nouri, K | 1 |
| Brandi, N | 1 |
| Starace, M | 1 |
| Alessandrini, A | 1 |
| Bruni, F | 1 |
| Piraccini, BM | 2 |
| Katoulis, AC | 2 |
| Diamanti, K | 2 |
| Sgouros, D | 2 |
| Liakou, AI | 2 |
| Bozi, E | 2 |
| Avgerinou, G | 1 |
| Panayiotides, I | 2 |
| Rigopoulos, D | 3 |
| Sundberg, JP | 1 |
| Lenzy, YM | 1 |
| McMichael, AJ | 1 |
| Christiano, AM | 1 |
| McGregor, T | 1 |
| Stenn, KS | 1 |
| Sivamani, RK | 1 |
| Pratt, CH | 1 |
| King, LE | 1 |
| Vogt, T | 1 |
| Thomas, C | 1 |
| Reichrath, J | 1 |
| Schilling, L | 1 |
| Mawlood, D | 1 |
| Christmann, R | 1 |
| Loretz, B | 1 |
| Schäfer, U | 1 |
| Lehr, CM | 1 |
| Müller, C | 1 |
| March-Rodríguez, A | 1 |
| Deza, G | 1 |
| Bertolín-Colilla, M | 1 |
| Flores-Terry, MÁ | 1 |
| García-Arpa, M | 1 |
| Franco-Muñóz, M | 1 |
| González-Ruiz, L | 1 |
| English, RS | 1 |
| Liszewski, W | 1 |
| Stoff, BK | 1 |
| Murad, A | 1 |
| Dina, Y | 2 |
| Okoye, GA | 1 |
| Aguh, C | 2 |
| Brunet-Possenti, F | 1 |
| Deschamps, L | 1 |
| Colboc, H | 1 |
| Somogyi, A | 1 |
| Medjoubi, K | 1 |
| Bazin, D | 1 |
| Descamps, V | 1 |
| Subash, J | 1 |
| Alexander, T | 1 |
| Beamer, V | 1 |
| McMichael, A | 2 |
| Nascimento, LLD | 1 |
| Enokihara, MMSES | 1 |
| Vasconcellos, MRA | 1 |
| Tzima, K | 1 |
| Doche, I | 1 |
| Romiti, R | 1 |
| Valente, NS | 1 |
| Kushner, CJ | 1 |
| Concha, JSS | 1 |
| Pearson, DR | 1 |
| Werth, VP | 1 |
| Thompson, CT | 1 |
| Castillo, D | 1 |
| Sabiq, S | 1 |
| Garcia-Robledo, JE | 1 |
| Aragón, CC | 1 |
| Nieto-Aristizábal, I | 1 |
| Vásquez, S | 1 |
| Montoya, C | 1 |
| Tobón, GJ | 1 |
| Ho, A | 1 |
| Nirmal, B | 1 |
| George, R | 1 |
| Uhlenhake, EE | 1 |
| Mehregan, DM | 1 |
| Fung, MA | 1 |
| Sharon, VR | 1 |
| Ratnarathorn, M | 1 |
| Konia, TH | 1 |
| Barr, KL | 1 |
| Jouanique, C | 1 |
| Reygagne, P | 1 |
| Chan, DV | 1 |
| Kartono, F | 1 |
| Ziegler, R | 1 |
| Abdulwahab, N | 1 |
| DiPaola, N | 1 |
| Flynn, J | 1 |
| Wong, HK | 1 |
| Wilk, M | 1 |
| Zelger, BG | 1 |
| Zelger, B | 1 |
| Kao, HK | 1 |
| Hsu, HH | 1 |
| Chuang, WY | 1 |
| Chang, KP | 1 |
| Chen, B | 1 |
| Guo, L | 1 |
| Stamatios, G | 1 |
| Ioannides, D | 1 |
| Tziotzios, C | 1 |
| Stefanato, CM | 3 |
| Fenton, DA | 2 |
| Simpson, MA | 1 |
| McGrath, JA | 1 |
| Jimenez, F | 2 |
| Poblet, E | 2 |
| Zimmerman, B | 1 |
| Bomar, L | 1 |
| Tan, KT | 1 |
| Messenger, AG | 1 |
| El-Domyati, M | 1 |
| Attia, S | 1 |
| Saleh, F | 1 |
| Abdel-Wahab, H | 1 |
| Robson, A | 1 |
| Calonje, JE | 1 |
| Luzar, B | 1 |
| Calonje, E | 1 |
| Camacho, I | 1 |
| Armenores, P | 1 |
| Shirato, K | 1 |
| Reid, C | 1 |
| Sidhu, S | 1 |
| Chew, AL | 1 |
| Bashir, SJ | 1 |
| Wain, EM | 1 |
| Aber, C | 1 |
| Torres, F | 1 |
| Mesinkovska, NA | 1 |
| Galiczynski, EM | 1 |
| Billings, SD | 1 |
| Khera, P | 1 |
| Ladizinski, B | 1 |
| Bazakas, A | 1 |
| Selim, MA | 1 |
| Olsen, EA | 2 |
| Stockmeier, M | 1 |
| Kunte, C | 1 |
| Sander, CA | 1 |
| Wolff, H | 1 |
| Naz, E | 1 |
| Vidaurrázaga, C | 1 |
| Hernández-Cano, N | 1 |
| Herranz, P | 1 |
| Mayor, M | 1 |
| Hervella, M | 1 |
| Casado, M | 1 |
| Dawn, G | 1 |
| Holmes, SC | 1 |
| Moffat, D | 1 |
| Munro, CS | 1 |
| Iorizzo, M | 1 |
| Misciali, C | 1 |
| Kossard, S | 3 |
| Shiell, RC | 1 |
| Jumez, N | 1 |
| Bessis, D | 1 |
| Guillot, B | 1 |
| Herrmann, A | 1 |
| Bormann, G | 1 |
| Marsch, WC | 1 |
| Wohlrab, J | 1 |
| Pascual, A | 1 |
| Piqué, E | 1 |
| Defo, D | 1 |
| Naouri, M | 1 |
| Martin, L | 1 |
| Estève, E | 1 |
| Yip, L | 1 |
| Mason, G | 1 |
| Pohl, M | 1 |
| Whiting, DA | 1 |
| Lee, MS | 1 |
| Wilkinson, B | 1 |
| Tighe, JV | 1 |
| Pui, MH | 1 |
| Du, JQ | 1 |
| Yueh, TC | 1 |
| Zeng, SQ | 1 |
| Torricelli, R | 1 |
| Guijarro, J | 1 |
| Silvestre, JF | 1 |
| Ramón, RL | 1 |
| Betlloch, MI | 1 |
| Botella, R | 1 |
| Trattner, A | 1 |
| David, M | 1 |
| Rothem, A | 1 |
| Ben-David, E | 1 |
| Sandbank, M | 1 |
| Matta, M | 1 |
| Kibbi, AG | 1 |
| Khattar, J | 1 |
| Salman, SM | 1 |
| Zaynoun, ST | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Proof of Concept Study to Evaluate the Efficacy, Safety and Tolerability of Secukinumab 300 mg Over 32 Weeks in Adult Patients With Biopsy-proven Forms of Lichen Planus Not Adequately Controlled With Topical Therapies - PRELUDE[NCT04300296] | Phase 2 | 111 participants (Actual) | Interventional | 2020-07-27 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Number of treatment responders at week 16, where response is defined as an Investigator's Global Assessment (IGA) score of 2 or lower at Week 16. IGA is measured on a scale from 0 - 4 with 0 = Clear, 1 = Minimal; 2 = Mild; 3 = Moderate; and 4 = Severe with 0 being best score and 4 being worst score. CLP=Cutaneous lichen planus, MLP=Mucosal lichen planus, LPP=Lichen planopilaris. Posterior median and 95% credible interval (instead of 95% confidence interval) were derived using Bayesian method based on beta-binomial model. (NCT04300296)
Timeframe: Baseline up to week 16
| Intervention | percentage of participants (Median) |
|---|---|
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | 44.0 |
| Placebo - TP 1 - CLP Cohort | 58.2 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | 37.5 |
| Placebo - TP 1 - MLP Cohort | 23.1 |
| AIN457 300 mg Q4W - TP 1 - LPP Cohort | 37.6 |
| Placebo - TP 1 - LPP Cohort | 30.9 |
The Physician Assessment of Surface Area of Disease (PSAD) evaluates the extent of cutaneous lesions estimated by investigator or qualified designee. Assessment scores range from 0-5, with lower scores corresponding to lower percentages of surface area with disease: 0=clear, 1=<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=>50% of total body surface (NCT04300296)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 2 0 score | Week 16 0 score | Week 16 1 score | Week 16 2 score | Week 16 3 score | Week 16 4 score | Week 16 5 score | Week 20 0 score | Week 20 1 score | Week 20 2 score | Week 20 3 score | Week 20 4 score | Week 20 5 score | Week 24 0 score | Week 24 1 score | Week 24 2 score | Week 24 3 score | Week 24 4 score | Week 24 5 score | Week 28 0 score | Week 28 1 score | Week 28 2 score | Week 28 3 score | Week 28 4 score | Week 28 5 score | Week 32 0 score | Week 32 1 score | Week 32 2 score | Week 32 3 score | Week 32 4 score | Week 32 5 score | |
| Placebo to AIN457 300 mg Q2W - TP 2 - CLP Cohort | 0 | 0 | 0 | 3 | 3 | 4 | 0 | 0 | 0 | 3 | 2 | 3 | 2 | 0 | 0 | 2 | 2 | 4 | 2 | 0 | 0 | 2 | 3 | 3 | 2 | 0 | 1 | 0 | 4 | 2 | 2 |
The Physician Assessment of Surface Area of Disease (PSAD) evaluates the extent of cutaneous lesions estimated by investigator or qualified designee. Assessment scores range from 0-5, with lower scores corresponding to lower percentages of surface area with disease: 0=clear, 1=<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=>50% of total body surface (NCT04300296)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline 0 Score | Baseline 1 score | Baseline 2 score | Baseline 3 score | Baseline 4 score | Baseline 5 score | Week 2 0 score | Week 2 1 score | Week 2 2 score | Week 2 3 score | Week 2 4 score | Week 2 5 score | Week 4 0 score | Week 4 1 score | Week 4 2 score | Week 4 3 score | Week 4 4 score | Week 4 5 score | Week 8 0 score | Week 8 1 score | Week 8 2 score | Week 8 3 score | Week 8 4 score | Week 8 5 score | Week 12 0 score | Week 12 1 score | Week 12 2 score | Week 12 3 score | Week 12 4 score | Week 12 5 score | Week 16 0 score | Week 16 1 score | Week 16 2 score | Week 16 3 score | Week 16 4 score | Week 16 5 score | |
| Placebo - TP 1 - CLP Cohort | 0 | 0 | 0 | 3 | 6 | 3 | 0 | 0 | 1 | 3 | 5 | 3 | 0 | 0 | 0 | 3 | 5 | 3 | 0 | 1 | 1 | 2 | 4 | 3 | 0 | 1 | 2 | 0 | 7 | 2 | 0 | 2 | 3 | 3 | 4 | 0 |
The Physician Assessment of Surface Area of Disease (PSAD) evaluates the extent of cutaneous lesions estimated by investigator or qualified designee. Assessment scores range from 0-5, with lower scores corresponding to lower percentages of surface area with disease: 0=clear, 1=<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=>50% of total body surface (NCT04300296)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline 0 Score | Baseline 1 score | Baseline 2 score | Baseline 3 score | Baseline 4 score | Baseline 5 score | Week 2 0 score | Week 2 1 score | Week 2 2 score | Week 2 3 score | Week 2 4 score | Week 2 5 score | Week 4 0 score | Week 4 1 score | Week 4 2 score | Week 4 3 score | Week 4 4 score | Week 4 5 score | Week 8 0 score | Week 8 1 score | Week 8 2 score | Week 8 3 score | Week 8 4 score | Week 8 5 score | Week 12 0 score | Week 12 1 score | Week 12 2 score | Week 12 3 score | Week 12 4 score | Week 12 5 score | Week 16 0 score | Week 16 1 score | Week 16 2 score | Week 16 3 score | Week 16 4 score | Week 16 5 score | Week 20 0 score | Week 20 1 score | Week 20 2 score | Week 20 3 score | Week 20 4 score | Week 20 5 score | Week 24 0 score | Week 24 1 score | Week 24 2 score | Week 24 3 score | Week 24 4 score | Week 24 5 score | Week 28 0 score | Week 28 1 score | Week 28 2 score | Week 28 3 score | Week 28 4 score | Week 28 5 score | Week 32 0 score | Week 32 1 score | Week 32 2 score | Week 32 3 score | Week 32 4 score | Week 32 5 score | |
| AIN457 300 mg Q4W - TP 1 and TP 2 - CLP Cohort | 0 | 3 | 6 | 6 | 5 | 5 | 0 | 6 | 5 | 9 | 3 | 2 | 0 | 3 | 8 | 8 | 3 | 2 | 0 | 7 | 5 | 7 | 4 | 2 | 0 | 6 | 7 | 7 | 3 | 2 | 0 | 4 | 12 | 5 | 2 | 2 | 0 | 6 | 12 | 3 | 1 | 2 | 1 | 8 | 10 | 1 | 2 | 3 | 0 | 6 | 11 | 1 | 3 | 2 | 2 | 5 | 10 | 3 | 1 | 3 |
"The Dermatology Life Quality Index (DLQI) is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment." (NCT04300296)
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| Baseline n=25,12,0 | Week 4 n=24,11,0 | Week 8 n=25,11,0 | Week 12 n=25,12,0 | Week 16 n=25,12,10 | |
| Placebo - TP 1 - CLP Cohort | 0 | 0 | 0 | 1 | 2 |
"The Dermatology Life Quality Index (DLQI) is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment." (NCT04300296)
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| Week 16 n=25,12,10 | Week 20 n=24,0,10 | Week 24 n=25,0,10 | Week 28 n=23,0,10 | Week 32 n=25,0,9 | |
| Placebo to AIN457 300 mg Q2W - TP 2 - CLP Cohort | 2 | 1 | 1 | 1 | 1 |
"The Dermatology Life Quality Index (DLQI) is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment." (NCT04300296)
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32
| Intervention | Participants (Count of Participants) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline n=25,12,0 | Week 4 n=24,11,0 | Week 8 n=25,11,0 | Week 12 n=25,12,0 | Week 16 n=25,12,10 | Week 20 n=24,0,10 | Week 24 n=25,0,10 | Week 28 n=23,0,10 | Week 32 n=25,0,9 | |
| AIN457 300 mg Q4W - TP 1 and TP 2 - CLP Cohort | 0 | 2 | 2 | 3 | 3 | 3 | 4 | 3 | 2 |
"The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts (Finlay and Khan 1994). The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment." (NCT04300296)
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| Baseline n=24,13,0 | Week 4 n=24,13,0 | Week 8 n=24,13,0 | Week 12 n=24,13,0 | Week 16 n=24,13,13 | |
| Placebo - TP 1 - LPP Cohort | 0 | 1 | 1 | 2 | 1 |
"The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts (Finlay and Khan 1994). The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment." (NCT04300296)
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| Week 16 n=24,13,13 | Week 20 n=24,0,13 | Week 24 n=23,0,13 | Week 28 n=24,0,13 | Week 32 n=24,0,11 | |
| Placebo to AIN457 300 mg Q2W TP 2 - LPP Cohort | 1 | 3 | 3 | 2 | 3 |
"The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts (Finlay and Khan 1994). The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment." (NCT04300296)
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32
| Intervention | Participants (Count of Participants) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline n=24,13,0 | Week 4 n=24,13,0 | Week 8 n=24,13,0 | Week 12 n=24,13,0 | Week 16 n=24,13,13 | Week 20 n=24,0,13 | Week 24 n=23,0,13 | Week 28 n=24,0,13 | Week 32 n=24,0,11 | |
| AIN457 300 mg Q4W - TP 1 and TP 2 - LPP Cohort | 0 | 3 | 3 | 2 | 2 | 4 | 2 | 2 | 1 |
"The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts (Finlay and Khan 1994). The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment." (NCT04300296)
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| Baseline n=24,13,0 | Week 4 n=24,13,0 | Week 8 n=24,13,0 | Week 12 n=24,13,0 | Week 16 n=24,13,11 | |
| Placebo - TP 1 - MLP Cohort | 0 | 1 | 1 | 2 | 3 |
"The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts (Finlay and Khan 1994). The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment." (NCT04300296)
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| Week 16 n=24,13,11 | Week 20 n=24,0,11 | Week 24 n=24,0,10 | Week 28 n=23,0,11 | Week 32 n=23,0,10 | |
| Placebo to AIN457 300 mg Q2W TP 2 - MLP Cohort | 2 | 2 | 3 | 2 | 2 |
"The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts (Finlay and Khan 1994). The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment." (NCT04300296)
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32
| Intervention | Participants (Count of Participants) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline n=24,13,0 | Week 4 n=24,13,0 | Week 8 n=24,13,0 | Week 12 n=24,13,0 | Week 16 n=24,13,11 | Week 20 n=24,0,11 | Week 24 n=24,0,10 | Week 28 n=23,0,11 | Week 32 n=23,0,10 | |
| AIN457 300 mg Q4W - TP 1 and TP 2- MLP Cohort | 0 | 2 | 4 | 4 | 5 | 7 | 7 | 3 | 4 |
Number of subjects with IGA of 2 or lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score. (NCT04300296)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
| Intervention | Participants (Count of Participants) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 2 IGA <=2 n=25,12,0 | Week 2 IGA improvement >=2 n=25,12,0 | Week 2 IGA 0/1 n=25,12,0 | Week 4 IGA <=2 n=24,11,0 | Week 4 IGA improvement. >=2 n=24,11,0 | Week 4 IGA 0/1 n=24,11,0 | Week 8 IGA <=2 n=25,11,0 | Week 8 IGA improvement. >=2 n=25,11,0 | Week 8 IGA 0/1 n=25,11,0 | Week 12 IGA <=2 n=25,12,0 | Week 12 IGA improvement. >=2 n=25,12,0 | Week 12 IGA 0/1 n=25,12,0 | Week16 IGA <=2 n=25,12,10 | Week 16 IGA improvement. >=2 n=25,12,10 | Week 16 IGA 0/1 n=25,12,10 | |
| Placebo - TP 1 - CLP Cohort | 1 | 0 | 0 | 2 | 0 | 0 | 3 | 1 | 1 | 4 | 2 | 1 | 7 | 3 | 2 |
Number of subjects with IGA of 2 or lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score. (NCT04300296)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
| Intervention | Participants (Count of Participants) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week16 IGA <=2 n=25,12,10 | Week 16 IGA improvement. >=2 n=25,12,10 | Week 16 IGA 0/1 n=25,12,10 | Week 20 IGA <=2 n=24,0,10 | Week 20 IGA improvement. >=2 n=24,0,10 | Week 20 IGA 0/1 n=24,0,10 | Week 24 IGA <=2 n=25,0,10 | Week 24 IGA improvement. >=2 n=25,0,10 | Week 24 IGA 0/1 n=25,0,10 | Week 28 IGA <=2 n=23,0,10 | Week 28 IGA improvement. >=2 n=23,0,10 | Week 28 IGA 0/1 n=23,0,10 | Week 32 IGA <=2 n=24,0,9 | Week 32 IGA improvement. >=2 n=24,0,9 | Week 32 IGA 0/1 n=24,0,9 | |
| Placebo to AIN457 300 mg Q2W - TP 2 - CLP Cohort | 5 | 1 | 0 | 1 | 1 | 1 | 3 | 2 | 1 | 4 | 1 | 1 | 2 | 2 | 1 |
Number of subjects with IGA of 2 or lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score. (NCT04300296)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 2 IGA <=2 n=25,12,0 | Week 2 IGA improvement >=2 n=25,12,0 | Week 2 IGA 0/1 n=25,12,0 | Week 4 IGA <=2 n=24,11,0 | Week 4 IGA improvement. >=2 n=24,11,0 | Week 4 IGA 0/1 n=24,11,0 | Week 8 IGA <=2 n=25,11,0 | Week 8 IGA improvement. >=2 n=25,11,0 | Week 8 IGA 0/1 n=25,11,0 | Week 12 IGA <=2 n=25,12,0 | Week 12 IGA improvement. >=2 n=25,12,0 | Week 12 IGA 0/1 n=25,12,0 | Week16 IGA <=2 n=25,12,10 | Week 16 IGA improvement. >=2 n=25,12,10 | Week 16 IGA 0/1 n=25,12,10 | Week 20 IGA <=2 n=24,0,10 | Week 20 IGA improvement. >=2 n=24,0,10 | Week 20 IGA 0/1 n=24,0,10 | Week 24 IGA <=2 n=25,0,10 | Week 24 IGA improvement. >=2 n=25,0,10 | Week 24 IGA 0/1 n=25,0,10 | Week 28 IGA <=2 n=23,0,10 | Week 28 IGA improvement. >=2 n=23,0,10 | Week 28 IGA 0/1 n=23,0,10 | Week 32 IGA <=2 n=24,0,9 | Week 32 IGA improvement. >=2 n=24,0,9 | Week 32 IGA 0/1 n=24,0,9 | |
| AIN457 300 mg Q4W - TP 1 and TP 2 - CLP Cohort | 5 | 2 | 2 | 9 | 3 | 2 | 10 | 4 | 3 | 10 | 3 | 4 | 11 | 4 | 4 | 11 | 5 | 5 | 14 | 10 | 10 | 12 | 7 | 6 | 9 | 7 | 6 |
Number of subjects with IGA of 2 or lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score. (NCT04300296)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
| Intervention | Participants (Count of Participants) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 2 IGA <=2 n=24,13,0 | Week 2 IGA improvement >=2 n=24,13,0 | Week 2 IGA 0/1 n=24,13,0 | Week 4 IGA <=2 n=24,13,0 | Week 4 IGA improvement. >=2 n=24,13,0 | Week 4 IGA 0/1 n=24,13,0 | Week 8 IGA <=2 n=24,13,0 | Week 8 IGA improvement. >=2 n=24,13,0 | Week 8 IGA 0/1 n=24,13,0 | Week 12 IGA <=2 n=24,13,0 | Week 12 IGA improvement. >=2 n=24,13,0 | Week 12 IGA 0/1 n=24,13,0 | Week16 IGA <=2 n=24,13,13 | Week 16 IGA improvement. >=2 n=24,13,13 | Week 16 IGA 0/1 n=24,13,13 | |
| Placebo - TP 1 - LPP Cohort | 1 | 0 | 0 | 2 | 1 | 1 | 3 | 1 | 1 | 4 | 2 | 2 | 4 | 0 | 0 |
Number of subjects with IGA of 2 or lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score. (NCT04300296)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
| Intervention | Participants (Count of Participants) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week16 IGA <=2 n=24,13,13 | Week 16 IGA improvement. >=2 n=24,13,13 | Week 16 IGA 0/1 n=24,13,13 | Week 20 IGA <=2 n=24,0,13 | Week 20 IGA improvement. >=2 n=24,0,13 | Week 20 IGA 0/1 n=24,0,13 | Week 24 IGA <=2 n=23,0,13 | Week 24 IGA improvement. >=2 n=23,0,13 | Week 24 IGA 0/1 n=23,0,13 | Week 28 IGA <=2 n=24,0,13 | Week 28 IGA improvement. >=2 n=24,0,13 | Week 28 IGA 0/1 n=24,0,13 | Week 32 IGA <=2 n==24,0,11 | Week 32 IGA improvement. >=2 n==24,0,11 | Week 32 IGA 0/1 n==24,0,11 | |
| Placebo to AIN457 300 mg Q2W - TP 2- LPP Cohort | 4 | 0 | 0 | 6 | 1 | 0 | 8 | 3 | 2 | 9 | 4 | 3 | 7 | 5 | 4 |
Number of subjects with IGA of 2 or lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score. (NCT04300296)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 2 IGA <=2 n=24,13,0 | Week 2 IGA improvement >=2 n=24,13,0 | Week 2 IGA 0/1 n=24,13,0 | Week 4 IGA <=2 n=24,13,0 | Week 4 IGA improvement. >=2 n=24,13,0 | Week 4 IGA 0/1 n=24,13,0 | Week 8 IGA <=2 n=24,13,0 | Week 8 IGA improvement. >=2 n=24,13,0 | Week 8 IGA 0/1 n=24,13,0 | Week 12 IGA <=2 n=24,13,0 | Week 12 IGA improvement. >=2 n=24,13,0 | Week 12 IGA 0/1 n=24,13,0 | Week16 IGA <=2 n=24,13,13 | Week 16 IGA improvement. >=2 n=24,13,13 | Week 16 IGA 0/1 n=24,13,13 | Week 20 IGA <=2 n=24,0,13 | Week 20 IGA improvement. >=2 n=24,0,13 | Week 20 IGA 0/1 n=24,0,13 | Week 24 IGA <=2 n=23,0,13 | Week 24 IGA improvement. >=2 n=23,0,13 | Week 24 IGA 0/1 n=23,0,13 | Week 28 IGA <=2 n=24,0,13 | Week 28 IGA improvement. >=2 n=24,0,13 | Week 28 IGA 0/1 n=24,0,13 | Week 32 IGA <=2 n==24,0,11 | Week 32 IGA improvement. >=2 n==24,0,11 | Week 32 IGA 0/1 n==24,0,11 | |
| AIN457 300 mg Q4W - TP 1 and TP 2 - LPP Cohort | 4 | 1 | 1 | 9 | 2 | 2 | 8 | 3 | 3 | 8 | 3 | 2 | 9 | 3 | 2 | 10 | 6 | 4 | 10 | 7 | 6 | 10 | 6 | 5 | 11 | 5 | 4 |
Number of subjects with IGA of 2 of lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score. (NCT04300296)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
| Intervention | Participants (Count of Participants) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 2 IGA <=2 n=24,12,0 | Week 2 IGA improvement >=2 n=24,12,0 | Week 2 IGA 0/1 n=24,12,0 | Week 4 IGA <=2 n=24,13,0 | Week 4 IGA improvement. >=2 n=24,13,0 | Week 4 IGA 0/1 n=24,13,0 | Week 8 IGA <=2 n=24,13,0 | Week 8 IGA improvement. >=2 n=24,13,0 | Week 8 IGA 0/1 n=24,13,0 | Week 12 IGA <=2 n=24,13,0 | Week 12 IGA improvement. >=2 n=24,13,0 | Week 12 IGA 0/1 n=24,13,0 | Week16 IGA <=2 n=24,13,11 | Week 16 IGA improvement. >=2 n=24,13,11 | Week 16 IGA 0/1 n=24,13,11 | |
| Placebo - TP 1 - MLP Cohort | 3 | 1 | 1 | 2 | 1 | 1 | 3 | 2 | 1 | 4 | 4 | 2 | 3 | 3 | 2 |
Number of subjects with IGA of 2 of lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score. (NCT04300296)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
| Intervention | Participants (Count of Participants) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week16 IGA <=2 n=24,13,11 | Week 16 IGA improvement. >=2 n=24,13,11 | Week 16 IGA 0/1 n=24,13,11 | Week 20 IGA <=2 n=24,0,11 | Week 20 IGA improvement. >=2 n=24,0,11 | Week 20 IGA 0/1 n=24,0,11 | Week 24 IGA <=2 n=24,0,10 | Week 24 IGA improvement. >=2 n=24,0,10 | Week 24 IGA 0/1 n=24,0,10 | Week 28 IGA <=2 n=23,0,11 | Week 28 IGA improvement. >=2 n=23,0,11 | Week 28 IGA 0/1 n=23,0,11 | Week 32 IGA <=2 n=23,0,10 | Week 32 IGA improvement. >=2 n=23,0,10 | Week 32 IGA 0/1 n=23,0,10 | |
| Placebo to AIN457 300 mg Q2W TP 2 - MLP Cohort | 1 | 1 | 0 | 3 | 2 | 1 | 4 | 2 | 0 | 4 | 3 | 0 | 2 | 1 | 0 |
Number of subjects with IGA of 2 of lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score. (NCT04300296)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 2 IGA <=2 n=24,12,0 | Week 2 IGA improvement >=2 n=24,12,0 | Week 2 IGA 0/1 n=24,12,0 | Week 4 IGA <=2 n=24,13,0 | Week 4 IGA improvement. >=2 n=24,13,0 | Week 4 IGA 0/1 n=24,13,0 | Week 8 IGA <=2 n=24,13,0 | Week 8 IGA improvement. >=2 n=24,13,0 | Week 8 IGA 0/1 n=24,13,0 | Week 12 IGA <=2 n=24,13,0 | Week 12 IGA improvement. >=2 n=24,13,0 | Week 12 IGA 0/1 n=24,13,0 | Week16 IGA <=2 n=24,13,11 | Week 16 IGA improvement. >=2 n=24,13,11 | Week 16 IGA 0/1 n=24,13,11 | Week 20 IGA <=2 n=24,0,11 | Week 20 IGA improvement. >=2 n=24,0,11 | Week 20 IGA 0/1 n=24,0,11 | Week 24 IGA <=2 n=24,0,10 | Week 24 IGA improvement. >=2 n=24,0,10 | Week 24 IGA 0/1 n=24,0,10 | Week 28 IGA <=2 n=23,0,11 | Week 28 IGA improvement. >=2 n=23,0,11 | Week 28 IGA 0/1 n=23,0,11 | Week 32 IGA <=2 n=23,0,10 | Week 32 IGA improvement. >=2 n=23,0,10 | Week 32 IGA 0/1 n=23,0,10 | |
| AIN457 300 mg Q4W - TP 1 and TP 2 - MLP Cohort | 5 | 1 | 1 | 4 | 1 | 1 | 5 | 0 | 0 | 5 | 5 | 4 | 9 | 5 | 4 | 10 | 5 | 5 | 10 | 3 | 3 | 7 | 1 | 1 | 9 | 2 | 2 |
The LPPAI assesses symptoms (pruritus, pain, burning), signs (erythema, perifollicular erythema and scale), a measure of activity (pull test) and extension of disease. These subjective and objective measures are assigned numeric values to establish a disease activity score. The total score ranges from 0 to 10, with higher scores corresponding to higher disease activity (NCT04300296)
Timeframe: Baseline, Week 16 and Week 32
| Intervention | scores on a scale (Mean) | |
|---|---|---|
| Baseline n=24,13,13 | Week 16 n=24,13,13 | |
| Placebo - TP 1 - LPP Cohort | 5.95 | -2.24 |
The LPPAI assesses symptoms (pruritus, pain, burning), signs (erythema, perifollicular erythema and scale), a measure of activity (pull test) and extension of disease. These subjective and objective measures are assigned numeric values to establish a disease activity score. The total score ranges from 0 to 10, with higher scores corresponding to higher disease activity (NCT04300296)
Timeframe: Baseline, Week 16 and Week 32
| Intervention | scores on a scale (Mean) | ||
|---|---|---|---|
| Baseline n=24,13,13 | Week 16 n=24,13,13 | Week 32 n=24,0,13 | |
| AIN457 300 mg Q4W - TP 1 and TP 2 - LPP Cohort | 5.92 | -1.44 | -2.44 |
| Placebo to AIN457 300 mg Q2W TP 2 - Lpp Cohort | 5.95 | -2.24 | -3.20 |
"Itch is assessed with the following questions: • Overall, how severe was your lichen planus-related itching during the past 24 hours? • How severe was your lichen planus-related itching at the worst moment during the past 24 hours? • Overall, how bothered were you by your lichen planus-related itching during the past 24 hours? Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning no itch and 10 meaning the worst itch imaginable." (NCT04300296)
Timeframe: Baseline, Week 16 and Week 32
| Intervention | scores on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline - Question 1 | Week 16 Severity of itch during past 24 hours n=25,12,10 | Baseline- Question 2 | Week 16 How severe was itch at worst moment during past 24 hours n=25,12,10 | Baseline- Question 3 | Week 16 How bothered by Itch during past 24 hours n=25,12,10 | |
| Placebo - TP 1 - CLP Cohort | 5.7 | -2.3 | 6.3 | -2.7 | 6.1 | -2.7 |
"Itch is assessed with the following questions: • Overall, how severe was your lichen planus-related itching during the past 24 hours? • How severe was your lichen planus-related itching at the worst moment during the past 24 hours? • Overall, how bothered were you by your lichen planus-related itching during the past 24 hours? Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning no itch and 10 meaning the worst itch imaginable." (NCT04300296)
Timeframe: Baseline, Week 16 and Week 32
| Intervention | scores on a scale (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline - Question 1 | Week 16 Severity of itch during past 24 hours n=25,12,10 | Week 32 Severity of itch during past 24 hours n=25,0,9 | Baseline- Question 2 | Week 16 How severe was itch at worst moment during past 24 hours n=25,12,10 | Week 32 How severe was itch at worst moment during past 24 hours n=25,0,9 | Baseline- Question 3 | Week 16 How bothered by Itch during past 24 hours n=25,12,10 | Week 32 How bothered by Itch during past 24 hours n=25,0,9 | |
| AIN457 300 mg Q4W - TP 1 and TP 2 - CLP Cohort | 5.1 | -0.8 | -1.5 | 5.6 | -0.9 | -1.3 | 4.8 | -1.0 | -1.1 |
| Placebo to AIN457 300 mg Q2W TP 2 - CLP Cohort | 5.8 | -2.0 | -1.1 | 5.9 | -1.9 | -1.2 | 6.1 | -2.4 | -1.2 |
"Itch is assessed with the following questions: • Overall, how severe was your lichen planus-related itching during the past 24 hours? • How severe was your lichen planus-related itching at the worst moment during the past 24 hours? • Overall, how bothered were you by your lichen planus-related itching during the past 24 hours? Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning no itch and 10 meaning the worst itch imaginable." (NCT04300296)
Timeframe: Baseline, Week 16 and Week 32
| Intervention | scores on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline - Question 1 n=24,13,13 | Week 16 Severity of itch during past 24 hours n=24,13,11 | Baseline - Question 2 n=24,13,13 | Week 16 How severe was itch at worst moment during past 24 hours n=24,13,13 | Baseline - Question 3 n=24,13,11 | Week 16 How bothered by Itch during past 24 hours n=24,13,13 | |
| Placebo - TP 1 - LPP Cohort | 3.8 | -1.1 | 4.2 | -1.3 | 3.2 | -1.2 |
"Itch is assessed with the following questions: • Overall, how severe was your lichen planus-related itching during the past 24 hours? • How severe was your lichen planus-related itching at the worst moment during the past 24 hours? • Overall, how bothered were you by your lichen planus-related itching during the past 24 hours? Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning no itch and 10 meaning the worst itch imaginable." (NCT04300296)
Timeframe: Baseline, Week 16 and Week 32
| Intervention | scores on a scale (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline - Question 1 n=24,13,13 | Week 16 Severity of itch during past 24 hours n=24,13,11 | Week 32 Severity of itch during past 24 hours n=24,0,11 | Baseline - Question 2 n=24,13,13 | Week 16 How severe was itch at worst moment during past 24 hours n=24,13,13 | Week 32 How severe was itch at worst moment during past 24 hours n=24,0,11 | Baseline - Question 3 n=24,13,11 | Week 16 How bothered by Itch during past 24 hours n=24,13,13 | Week 32 How bothered by Itch during past 24 hours n=24,0,11 | |
| AIN457 300 mg Q4W - TP 1 and TP 2 - LPP Cohort | 4.5 | -0.5 | -1.6 | 5.1 | -0.7 | -1.8 | 4.0 | -0.4 | -1.7 |
| Placebo to AIN457 300 mg Q2W - TP 2 - LPP Cohort | 3.8 | -1.1 | -2.4 | 4.1 | -1.3 | -2.6 | 3.2 | -1.2 | -2.2 |
"Itch is assessed with the following questions: • Overall, how severe was your lichen planus-related itching during the past 24 hours? • How severe was your lichen planus-related itching at the worst moment during the past 24 hours? • Overall, how bothered were you by your lichen planus-related itching during the past 24 hours? Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning no itch and 10 meaning the worst itch imaginable." (NCT04300296)
Timeframe: Baseline, Week 16 and Week 32
| Intervention | scores on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline - Question 1 n=23,13,11 | Week 16 Severity of itch during past 24 hours n=23,13,11 | Baseline - Question 2 n=23,13,11 | Week 16 How severe was itch at worst moment during past 24 hours n=23,13,11 | Baseline - Question 3 n=24,13,11 | Week 16 How bothered by Itch during past 24 hours n=23,13,11 | |
| Placebo - TP 1 - MLP Cohort | 3.8 | -0.2 | 3.6 | 0.4 | 4.0 | 0.1 |
"Itch is assessed with the following questions: • Overall, how severe was your lichen planus-related itching during the past 24 hours? • How severe was your lichen planus-related itching at the worst moment during the past 24 hours? • Overall, how bothered were you by your lichen planus-related itching during the past 24 hours? Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning no itch and 10 meaning the worst itch imaginable." (NCT04300296)
Timeframe: Baseline, Week 16 and Week 32
| Intervention | scores on a scale (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline - Question 1 n=23,13,11 | Week 16 Severity of itch during past 24 hours n=23,13,11 | Week 32 Severity of itch during past 24 hours n=22,0,10 | Baseline - Question 2 n=23,13,11 | Week 16 How severe was itch at worst moment during past 24 hours n=23,13,11 | Week 32 How severe was itch at worst moment during past 24 hours n=22,0,10 | Baseline - Question 3 n=24,13,11 | Week 16 How bothered by Itch during past 24 hours n=23,13,11 | Week 32 How bothered by Itch during past 24 hours n=22,0,10 | |
| AIN457 300 mg Q4W - TP 1 and TP 2 - MLP Cohort | 2.5 | 0.3 | 0.1 | 2.4 | 0.8 | 0.3 | 3.4 | -0.5 | -0.2 |
| Placebo to AIN457 300 mg Q2W TP 2 - MLP Cohort | 4.3 | -0.3 | -0.4 | 4.1 | 0.4 | 0.4 | 4.5 | 0.0 | -0.4 |
"Pain is assessed with the following questions: • Overall, how severe was your lichen planus-related pain during the past 24 hours? • How severe was your lichen planus-related pain at the worst moment during the past 24 hours? • Overall, how bothered were you by your lichen planus-related pain during the past 24 hours? Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning no pain and 10 meaning the worst pain imaginable." (NCT04300296)
Timeframe: Baseline, Week 16 and Week 32
| Intervention | scores on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline - Question 1 n=25,12,10 | Week 16 Severity of pain during past 24 hours n=25,12,10 | Baseline - Question 2 n=25,12,10 | Week 16 How severe was pain at worst moment during past 24 hours n=25,12,10 | Baseline - Question 3 n=25,12,10 | Week 16 How bothered by pain during past 24 hour n=25,12,10 | |
| Placebo - TP 1 - CLP Cohort | 3.4 | -0.8 | 3.9 | -1.2 | 3.7 | -0.6 |
"Pain is assessed with the following questions: • Overall, how severe was your lichen planus-related pain during the past 24 hours? • How severe was your lichen planus-related pain at the worst moment during the past 24 hours? • Overall, how bothered were you by your lichen planus-related pain during the past 24 hours? Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning no pain and 10 meaning the worst pain imaginable." (NCT04300296)
Timeframe: Baseline, Week 16 and Week 32
| Intervention | scores on a scale (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline - Question 1 n=25,12,10 | Week 16 Severity of pain during past 24 hours n=25,12,10 | Week 32 Severity of pain during past 24 hours n=25,0,9 | Baseline - Question 2 n=25,12,10 | Week 16 How severe was pain at worst moment during past 24 hours n=25,12,10 | Week 32 How severe was pain at worst moment during past 24 hours n=25,0,9 | Baseline - Question 3 n=25,12,10 | Week 16 How bothered by pain during past 24 hour n=25,12,10 | Week 32 How bothered by pain during past 24 hours n=25, 0,9 | |
| AIN457 300 mg Q4W - TP 1 and TP 2 - CLP Cohort | 1.09 | 0.2 | -0.3 | 2.2 | 0.1 | -0.4 | 2.1 | 0.1 | -0.2 |
| Placebo to AIN457 300 mg Q2W - TP 2 - CLP Cohort | 3.5 | -0.8 | -0.3 | 3.9 | -1.0 | -0.4 | 3.8 | 0.5 | -0.3 |
"Pain is assessed with the following questions: • Overall, how severe was your lichen planus-related pain during the past 24 hours? • How severe was your lichen planus-related pain at the worst moment during the past 24 hours? • Overall, how bothered were you by your lichen planus-related pain during the past 24 hours? Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning no pain and 10 meaning the worst pain imaginable." (NCT04300296)
Timeframe: Baseline, Week 16 and Week 32
| Intervention | scores on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline - Question 1 n=24,13,12 | Week 16 Severity of pain during past 24 hours n=24,13,12 | Baseline - Question 2 24,13,12 | Week 16 How severe was pain at worst moment during past 24 hours n=24,13,12 | Baseline - Question 3 n=24,13,12 | Week 16 How bothered by pain during past 24 hour n=24,13,12 | |
| Placebo - TP 1 - LPP Cohort | 2.0 | -0.5 | 2.5 | -0.9 | 2.4 | -1.1 |
"Pain is assessed with the following questions: • Overall, how severe was your lichen planus-related pain during the past 24 hours? • How severe was your lichen planus-related pain at the worst moment during the past 24 hours? • Overall, how bothered were you by your lichen planus-related pain during the past 24 hours? Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning no pain and 10 meaning the worst pain imaginable." (NCT04300296)
Timeframe: Baseline, Week 16 and Week 32
| Intervention | scores on a scale (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline - Question 1 n=24,13,12 | Week 16 Severity of pain during past 24 hours n=24,13,12 | Week 32 Severity of pain during past 24 hours n=24,0,11 | Baseline - Question 2 24,13,12 | Week 16 How severe was pain at worst moment during past 24 hours n=24,13,12 | Week 32 How severe was pain at worst moment during past 24 hours n=24,0,11 | Baseline - Question 3 n=24,13,12 | Week 16 How bothered by pain during past 24 hour n=24,13,12 | Week 32 How bothered by pain during past 24 hours n=24,0,11 | |
| AIN457 300 mg Q4W - TP 1 and TP 2 - LPP Cohort | 2.5 | 0.3 | -0.6 | 2.8 | 0.2 | -0.8 | 2.7 | 0.0 | -0.8 |
| Placebo to AIN457 300 mg Q2W - TP 2 - LPP Cohort | 2.0 | -0.5 | -1.5 | 2.5 | -0.9 | -2.0 | 2.4 | -1.1 | -1.9 |
"Pain is assessed with the following questions: • Overall, how severe was your lichen planus-related pain during the past 24 hours? • How severe was your lichen planus-related pain at the worst moment during the past 24 hours? • Overall, how bothered were you by your lichen planus-related pain during the past 24 hours? Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning no pain and 10 meaning the worst pain imaginable." (NCT04300296)
Timeframe: Baseline, Week 16 and Week 32
| Intervention | scores on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline - Question 1 n=24,13,11 | Week 16 Severity of pain during past 24 hours n=24,13,11 | Baseline - Question 2 n=24,13,11 | Week 16 How severe was pain at worst moment during past 24 hours n=24,13,11 | Baseline - Question 3 n=24,13,11 | Week 16 How bothered by pain during past 24 hour n=24,13,11 | |
| Placebo - TP 1 - MLP Cohort | 5.9 | -0.1 | 6.4 | -0.3 | 6.5 | -0.3 |
"Pain is assessed with the following questions: • Overall, how severe was your lichen planus-related pain during the past 24 hours? • How severe was your lichen planus-related pain at the worst moment during the past 24 hours? • Overall, how bothered were you by your lichen planus-related pain during the past 24 hours? Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning no pain and 10 meaning the worst pain imaginable." (NCT04300296)
Timeframe: Baseline, Week 16 and Week 32
| Intervention | scores on a scale (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline - Question 1 n=24,13,11 | Week 16 Severity of pain during past 24 hours n=24,13,11 | Week 32 Severity of pain during past 24 hours n=23,0,10 | Baseline - Question 2 n=24,13,11 | Week 16 How severe was pain at worst moment during past 24 hours n=24,13,11 | Week 32 How severe was pain at worst moment during past 24 hours n=23,0,10 | Baseline - Question 3 n=24,13,11 | Week 16 How bothered by pain during past 24 hour n=24,13,11 | Week 32 How bothered by pain during past 24 hours n=23,0,10 | |
| AIN457 300 mg Q4W - TP 1 and TP 2 - MLP Cohort | 5.1 | -0.5 | -0.3 | 5.4 | -0.5 | -0.3 | 5.5 | -0.8 | -0.5 |
| Placebo to AIN457 300 mg Q2W TP 2 - MLP Cohort | 6.3 | 0.0 | -0.6 | 6.7 | -0.2 | -0.5 | 6.8 | -0.1 | -0.9 |
Scalpdex is a self-administered, health-related quality of life instrument originally developed for scalp dermatitis. This survey includes 23 items, each item scored on a scale of 0-100, where 0=never, 25=rarely, 50=sometimes, 75=often and 100=all the time. The 23 items pertain to 3 domains: symptom, emotions and functioning. Subjects were asked to score themselves on how true each of the 23 statements has been for them over the past four weeks. the total score is the average of the scores of the 23 items. A higher total score indicated a higher impairment in quality of life. (NCT04300296)
Timeframe: Baseline, Week 16 and Week 32
| Intervention | scores on a scale (Mean) | |
|---|---|---|
| Baseline n=24,13,12 | Week 16 n=24,13,12 | |
| Placebo - TP 1 - LPP Cohort | 54.01 | -6.94 |
Scalpdex is a self-administered, health-related quality of life instrument originally developed for scalp dermatitis. This survey includes 23 items, each item scored on a scale of 0-100, where 0=never, 25=rarely, 50=sometimes, 75=often and 100=all the time. The 23 items pertain to 3 domains: symptom, emotions and functioning. Subjects were asked to score themselves on how true each of the 23 statements has been for them over the past four weeks. the total score is the average of the scores of the 23 items. A higher total score indicated a higher impairment in quality of life. (NCT04300296)
Timeframe: Baseline, Week 16 and Week 32
| Intervention | scores on a scale (Mean) | ||
|---|---|---|---|
| Baseline n=24,13,12 | Week 16 n=24,13,12 | Week 32 n=24,0,11 | |
| AIN457 300 mg Q4W - TP 1 and TP 2 -LPP Cohort | 55.75 | 1.86 | -4.26 |
| Placebo to AIN457 300 mg Q2W - TP 2 - LPP Cohort | 54.01 | -6.94 | -14.43 |
OLPSSM is a self-administered assessment of the symptom experience of subjects with oral LP in clinical studies. It includes 7 triggers contributing to soreness of oral lichen planus: Brushing teeth, eating food, drinking liquids, smiling, breathing through mouth, talking and touching. These 7 items contributed equally to a total OLP symptom severity score, ranging from 0 to 28, with higher scores indicating worse severity. (NCT04300296)
Timeframe: Baseline, Week 16 and Week 32
| Intervention | scores on a scale (Mean) | |
|---|---|---|
| Baseline n=21,12,10 | Week 16 n=21,12,10 | |
| Placebo - TP 1 - MLP Cohort | 13.4 | 0.8 |
OLPSSM is a self-administered assessment of the symptom experience of subjects with oral LP in clinical studies. It includes 7 triggers contributing to soreness of oral lichen planus: Brushing teeth, eating food, drinking liquids, smiling, breathing through mouth, talking and touching. These 7 items contributed equally to a total OLP symptom severity score, ranging from 0 to 28, with higher scores indicating worse severity. (NCT04300296)
Timeframe: Baseline, Week 16 and Week 32
| Intervention | scores on a scale (Mean) | ||
|---|---|---|---|
| Baseline n=21,12,10 | Week 16 n=21,12,10 | Week 32 n=20,0,9 | |
| AIN457 300 mg Q4W - TP 1 and TP 2 - MLP Cohort | 11.0 | -1.0 | -1.8 |
| Placebo to AIN457 300 mg Q2W TP 2 - MLP Cohort | 13.9 | -0.4 | -0.7 |
REU measured disease severity based on 3 dimensions: reticulation, erythema and ulceration for all subjects in the MLP cohort who had an oral presentation of the disease. The total score ranged from 0-115 with higher values corresponding to higher activity of the disease. (NCT04300296)
Timeframe: Baseline, Week 16 and Week 32
| Intervention | scores on a scale (Mean) | |
|---|---|---|
| Baseline n=21,12,10 | Week 16 n=21,12,10 | |
| Placebo - TP 1 - MLP Cohort | 25.29 | -5.79 |
REU measured disease severity based on 3 dimensions: reticulation, erythema and ulceration for all subjects in the MLP cohort who had an oral presentation of the disease. The total score ranged from 0-115 with higher values corresponding to higher activity of the disease. (NCT04300296)
Timeframe: Baseline, Week 16 and Week 32
| Intervention | scores on a scale (Mean) | ||
|---|---|---|---|
| Baseline n=21,12,10 | Week 16 n=21,12,10 | Week 32 n=20,0,9 | |
| AIN457 300 mg Q4W - TP 1 and TP 2 - MLP Cohort | 21.31 | -4.83 | -6.08 |
| Placebo to AIN457 300 mg Q2W TP 2 - MLP Cohort | 26.95 | -4.10 | -2.17 |
10 reviews available for salicylic acid and Fibrosis
| Article | Year |
|---|---|
[Frontal fibrosing alopecia-update].
Topics: Adolescent; Alopecia; Eyebrows; Female; Fibrosis; Humans; Inflammation; Lichen Planus; Male; Scalp | 2022 |
Fibrosing alopecia in a pattern distribution.
Topics: Alopecia; Female; Fibrosis; Hair Follicle; Humans; Lichen Planus; Male; Middle Aged; Scalp | 2021 |
[Postmenopausal lichen planopilaris also known as fibrosing frontotemporal alopecia Kossard : An evidence-oriented practical guide to treatment from the University of the Saarland, Hair Research Center of the Dr. Rolf M. Schwiete Foundation].
Topics: Adult; Aged; Algorithms; Alopecia; Diagnosis, Differential; Evidence-Based Medicine; Female; Fibrosi | 2018 |
5-alpha-reductase inhibitor treatment for frontal fibrosing alopecia: an evidence-based treatment update.
Topics: 5-alpha Reductase Inhibitors; Alopecia; Breast Neoplasms; Depression; Dutasteride; Evidence-Based Me | 2018 |
A proposed mechanism for central centrifugal cicatricial alopecia.
Topics: Alopecia; Cicatrix; Fibrosis; Humans; Kidney; Kidney Diseases; Lichen Planus; PPAR gamma; Scalp; Scl | 2020 |
Algorithmic approach to the treatment of frontal fibrosing alopecia: A systematic review.
Topics: Algorithms; Alopecia; Fibrosis; Humans; Scalp | 2021 |
Medical therapy for frontal fibrosing alopecia: A review and clinical approach.
Topics: 5-alpha Reductase Inhibitors; Adrenal Cortex Hormones; Alopecia; Anti-Inflammatory Agents; Fibrosis; | 2019 |
Primary scarring alopecias.
Topics: Acne Keloid; Alopecia; Cellulitis; Cicatrix; Fibrosis; Folliculitis; Humans; Lichen Planus; Lupus Er | 2015 |
Frontal fibrosing alopecia: reflections and hypotheses on aetiology and pathogenesis.
Topics: Alopecia; Fibrosis; Humans; Scalp | 2016 |
Post-menopausal frontal fibrosing alopecia.
Topics: Aged; Alopecia; Female; Fibrosis; Hair Follicle; Humans; Postmenopause; Scalp | 2003 |
76 other studies available for salicylic acid and Fibrosis
| Article | Year |
|---|---|
Evaluating the association of central centrifugal cicatricial alopecia (CCCA) and fibroproliferative disorders.
Topics: Adult; Aged; Aged, 80 and over; Alopecia; Black or African American; Body Mass Index; Cicatrix; Fema | 2021 |
IL-17 Expression in the Perifollicular Fibrosis in Biopsies From Lichen Planopilaris.
Topics: Alopecia; Biopsy; Cicatrix; Fibrosis; Humans; Interleukin-17; Lichen Planus; Retrospective Studies; | 2022 |
A multicenter descriptive analysis of 270 men with frontal fibrosing alopecia and lichen planopilaris in the United States.
Topics: Alopecia; Fibrosis; Humans; Lichen Planus; Male; Scalp; United States | 2023 |
A multicenter descriptive analysis of 270 men with frontal fibrosing alopecia and lichen planopilaris in the United States.
Topics: Alopecia; Fibrosis; Humans; Lichen Planus; Male; Scalp; United States | 2023 |
A multicenter descriptive analysis of 270 men with frontal fibrosing alopecia and lichen planopilaris in the United States.
Topics: Alopecia; Fibrosis; Humans; Lichen Planus; Male; Scalp; United States | 2023 |
A multicenter descriptive analysis of 270 men with frontal fibrosing alopecia and lichen planopilaris in the United States.
Topics: Alopecia; Fibrosis; Humans; Lichen Planus; Male; Scalp; United States | 2023 |
A multicenter descriptive analysis of 270 men with frontal fibrosing alopecia and lichen planopilaris in the United States.
Topics: Alopecia; Fibrosis; Humans; Lichen Planus; Male; Scalp; United States | 2023 |
A multicenter descriptive analysis of 270 men with frontal fibrosing alopecia and lichen planopilaris in the United States.
Topics: Alopecia; Fibrosis; Humans; Lichen Planus; Male; Scalp; United States | 2023 |
A multicenter descriptive analysis of 270 men with frontal fibrosing alopecia and lichen planopilaris in the United States.
Topics: Alopecia; Fibrosis; Humans; Lichen Planus; Male; Scalp; United States | 2023 |
A multicenter descriptive analysis of 270 men with frontal fibrosing alopecia and lichen planopilaris in the United States.
Topics: Alopecia; Fibrosis; Humans; Lichen Planus; Male; Scalp; United States | 2023 |
A multicenter descriptive analysis of 270 men with frontal fibrosing alopecia and lichen planopilaris in the United States.
Topics: Alopecia; Fibrosis; Humans; Lichen Planus; Male; Scalp; United States | 2023 |
Protein profiling of forehead epidermal corneocytes distinguishes frontal fibrosing from androgenetic alopecia.
Topics: Alopecia; Epidermis; Fibrosis; Forehead; Humans; Lichen Planus; Scalp; Skin | 2023 |
Pattern hair loss: Assessment of inflammation and fibrosis on histologic sections.
Topics: Adult; Aged; Alopecia; Female; Fibrosis; Humans; Inflammation; Male; Middle Aged; Scalp | 2020 |
Frontal fibrosing alopecia in Asians: a retrospective clinical study.
Topics: 5-alpha Reductase Inhibitors; Adrenal Cortex Hormones; Adult; Aged; Aged, 80 and over; Alopecia; Asi | 2020 |
Clinical-histopathological profile of the frontal fibrosing alopecia: a retrospective study of 16 cases of a university hospital.
Topics: Adult; Aged; Aged, 80 and over; Alopecia; Biopsy; Dermoscopy; Female; Fibrosis; Hair Follicle; Hospi | 2019 |
Recalcitrant lichen planopilaris and frontal fibrosing alopecia responding to tildrakizumab.
Topics: Alopecia; Antibodies, Monoclonal, Humanized; Cicatrix; Fibrosis; Humans; Lichen Planus; Scalp | 2020 |
Effectiveness of dutasteride in a large series of patients with frontal fibrosing alopecia in real clinical practice.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Alopecia; Dose-Response Relationship, Drug; Du | 2021 |
Frontal fibrosing alopecia sparing a vascular naevus: the Renbök phenomenon.
Topics: Aged; Alopecia; Female; Fibrosis; Head and Neck Neoplasms; Humans; Nevus; Scalp; Skin Neoplasms | 2021 |
Frontal Fibrosing Alopecia: Successfully Treated with Methotrexate or Just the Natural Disease Progression?
Topics: Alopecia; Dermatologic Agents; Disease Progression; Female; Fibrosis; Humans; Methotrexate; Middle A | 2020 |
Colour Doppler ultrasound study in patients with frontal fibrosing alopecia.
Topics: Alopecia; Cross-Sectional Studies; Female; Fibrosis; Humans; Lichen Planus; Scalp; Ultrasonography, | 2021 |
Confronting frontal fibrosing alopecia.
Topics: Alopecia; Fibrosis; Humans; Scalp | 2021 |
Scalp and serum profiling of frontal fibrosing alopecia reveals scalp immune and fibrosis dysregulation with no systemic involvement.
Topics: Alopecia; Alopecia Areata; Biomarkers; Cross-Sectional Studies; Female; Fibrosis; Humans; Lichen Pla | 2022 |
Scalp demodicosis developing in a patient with frontal fibrosing alopecia: a clinical and trichoscopic mimicker of active disease.
Topics: Alopecia; Fibrosis; Humans; Lichen Planus; Scalp | 2022 |
Frontal fibrosing alopecia in a 46-year-old man.
Topics: Alopecia; Fibrosis; Humans; Male; Middle Aged; Scalp; Scalp Dermatoses | 2016 |
Adipocyte-myofibroblast transition as a possible pathophysiological step in androgenetic alopecia.
Topics: Adipocytes; Alopecia; Androgens; Animals; Female; Fibrosis; Hair Follicle; Humans; Male; Mice; Model | 2017 |
Thermal imaging and dermoscopy for detecting inflammation in frontal fibrosing alopecia.
Topics: Aged; Aged, 80 and over; Alopecia; Biopsy; Dermoscopy; Female; Fibrosis; Humans; Inflammation; Middl | 2018 |
Hair transplantation for the treatment of lichen planopilaris and frontal fibrosing alopecia: A report of two cases.
Topics: Adult; Alopecia; Female; Fibrosis; Forehead; Hair; Humans; Lichen Planus; Middle Aged; Scalp | 2018 |
Optical coherence tomography for the investigation of frontal fibrosing alopecia.
Topics: Adult; Aged; Alopecia; Arm; Cicatrix; Epidermis; Eyebrows; Female; Fibrosis; Forehead; Humans; Middl | 2018 |
The doll hairline: A clue for the diagnosis of frontal fibrosing alopecia.
Topics: Alopecia; Fibrosis; Humans; Scalp | 2017 |
Is there a pathogenetic link between frontal fibrosing alopecia, androgenetic alopecia and fibrosing alopecia in a pattern distribution?
Topics: Adult; Aged; Aged, 80 and over; Alopecia; Cicatrix; Dermoscopy; Female; Fibrosis; Humans; Menopause; | 2018 |
Cicatricial Alopecia Research Foundation meeting, May 2016: Progress towards the diagnosis, treatment and cure of primary cicatricial alopecias.
Topics: Alopecia; Animals; Cicatrix; Disease Models, Animal; Dogs; Fibrosis; Humans; Lichen Planus; Mice; Sc | 2018 |
Frontal fibrosing alopecia after antiandrogen hormonal therapy in a male patient.
Topics: Adenocarcinoma; Aged, 80 and over; Alopecia; Anilides; Antineoplastic Combined Chemotherapy Protocol | 2018 |
Facial Papules in Frontal Fibrosing Alopecia: Good Response to Isotretinoin.
Topics: Adult; Alopecia; Dermatologic Agents; Facial Dermatoses; Female; Fibrosis; Humans; Isotretinoin; Mid | 2018 |
A hypothetical pathogenesis model for androgenic alopecia: clarifying the dihydrotestosterone paradox and rate-limiting recovery factors.
Topics: Alopecia; Androgens; Biomarkers; Dihydrotestosterone; Disease Progression; Estrogens; Female; Fibros | 2018 |
The ethics of medical marijuana in dermatology.
Topics: Alopecia; Dermatology; Drug Prescriptions; Female; Fibrosis; Humans; Medical Marijuana; Middle Aged; | 2018 |
The timing and distribution of nonscalp hair loss in patients with lichen planopilaris and frontal fibrosing alopecia: A survey-based study.
Topics: Alopecia; Female; Fibrosis; Humans; Lichen Planus; Middle Aged; Scalp; Self Report; Time Factors | 2021 |
Detection of titanium nanoparticles in the hair shafts of a patient with frontal fibrosing alopecia.
Topics: Aged; Alopecia; Female; Fibrosis; Hair; Humans; Microscopy, Electron, Scanning; Nanoparticles; Scalp | 2018 |
Coexistence of chronic cutaneous lupus erythematosus and frontal fibrosing alopecia.
Topics: Alopecia; Biopsy; Dermoscopy; Female; Fibrosis; Humans; Lichenoid Eruptions; Lupus Erythematosus, Di | 2018 |
Frontal fibrosing alopecia: is the melanocyte of the upper hair follicle the antigenic target?
Topics: Aged; Alopecia; Autoimmune Diseases; Female; Fibrosis; Forehead; Hair Follicle; Humans; Male; Melano | 2018 |
"Normal-appearing" scalp areas are also affected in lichen planopilaris and frontal fibrosing alopecia: An observational histopathologic study of 40 patients.
Topics: Adult; Aged; Aged, 80 and over; Alopecia; Biopsy; Dermatology; Female; Fibrosis; Humans; Inflammatio | 2020 |
Lichen Planus Pigmentosus and Frontal Fibrosing Alopecia Mimicking Discoid Lupus Erythematosus.
Topics: Aged; Alopecia; Diagnosis, Differential; Female; Fibrosis; Humans; Lichen Planus; Lupus Erythematosu | 2019 |
A method for more precise sampling of the scalp and eyebrows in frontal fibrosing alopecia.
Topics: Alopecia; Biopsy; Dermoscopy; Epidermis; Fibrosis; Hair Follicle; Humans; Lymphocytes; Microtomy; Pa | 2019 |
Adipose Infiltration of the Dermis, Involving the Arrector Pili Muscle, and Dermal Displacement of Eccrine Sweat Coils: New Histologic Observations in Frontal Fibrosing Alopecia.
Topics: Adipose Tissue; Alopecia; Biopsy; Dermis; Eccrine Glands; Fibrosis; Forehead; Hair Follicle; Humans; | 2019 |
Frontal fibrosing alopecia: A new autoimmune entity?
Topics: Adult; Aged; Alopecia; Animals; Autoimmune Diseases; Cicatrix; Female; Fibrosis; Humans; Lichen Plan | 2019 |
Blink sign in dermatoscopy of cicatricial alopecia.
Topics: Alopecia; Cicatrix; Dermoscopy; Diagnosis, Differential; Fibrosis; Humans; Scalp; Skin | 2019 |
Prospective histologic examinations in patients who practice traumatic hairstyling.
Topics: Adult; Alopecia; Beauty Culture; Biopsy; Black or African American; Cicatrix; Female; Fibrosis; Hair | 2013 |
Elastin staining patterns in primary cicatricial alopecia.
Topics: Adult; Aged; Aged, 80 and over; Alopecia; Elastic Tissue; Elastin; Female; Fibrosis; Humans; Male; M | 2013 |
[Frontal fibrosing alopecia].
Topics: Alopecia; Dermoscopy; Diagnosis, Differential; Disease Progression; Europe; Eyebrows; Female; Fibros | 2014 |
Absence of HLA-DR1 positivity in 2 familial cases of frontal fibrosing alopecia.
Topics: Alopecia; Antibodies; Female; Fibrosis; HLA-DR1 Antigen; Humans; Lichen Planus; Middle Aged; Scalp; | 2014 |
Lichen planopilaris with foreign-body granuloma.
Topics: Alopecia; Biopsy; Fibrosis; Granuloma, Foreign-Body; Hair Follicle; Humans; Lichen Planus; Male; Mid | 2015 |
Experimental study of fat grafting under negative pressure for wounds with exposed bone.
Topics: Adipose Tissue; Animals; Bone and Bones; Cell Proliferation; Fibrosis; Granulation Tissue; Models, A | 2015 |
Frontal fibrosing alopecia: a disease fascinating for the researcher, disappointing for the clinician and distressing for the patient.
Topics: Alopecia; Fibrosis; Humans; Lichen Planus; Scalp | 2016 |
Cocking the eyebrows to find the missing hairline in frontal fibrosing alopecia: A useful clinical maneuver.
Topics: Aged; Alopecia; Eyebrows; Female; Fibrosis; Forehead; Humans; Muscle Contraction; Muscle, Skeletal; | 2016 |
Frontal fibrosing alopecia.
Topics: Aged; Alopecia; Female; Fibrosis; Hair Preparations; Humans; Laser Therapy; Lichen Planus; Male; Sca | 2017 |
Frontal fibrosing alopecia: clinical presentations and prognosis.
Topics: Adult; Aged; Alopecia; Cicatrix; Disease Progression; Eyebrows; Female; Fibrosis; Forehead; Hair Fol | 2009 |
Androgenetic alopecia in males: a histopathological and ultrastructural study.
Topics: Adult; Age Factors; Aged; Alopecia; Biopsy; Case-Control Studies; Collagen; Fibrosis; Hair Follicle; | 2009 |
The histopathologic spectrum of regression in atypical fibroxanthoma.
Topics: Aged; Aged, 80 and over; Cheek; Female; Fibrosis; Head and Neck Neoplasms; Histiocytoma, Benign Fibr | 2010 |
Morphological and immunohistochemical characteristics of atypical fibroxanthoma with a special emphasis on potential diagnostic pitfalls: a review.
Topics: Aged; Aged, 80 and over; Arm; Biomarkers, Tumor; Diagnosis, Differential; Female; Fibrosis; Head and | 2010 |
Acute hair loss on the limbs in frontal fibrosing alopecia: a clinicopathological study of two cases.
Topics: Acute Disease; Adult; Alopecia; Biopsy; Eyebrows; Female; Fibrosis; Hair Follicle; Humans; Middle Ag | 2010 |
Frontal fibrosing alopecia associated with generalized hair loss.
Topics: Aged; Alopecia; Eyebrows; Female; Fibrosis; Hair; Humans; Lichen Planus; Middle Aged; Postmenopause; | 2010 |
Expanding the spectrum of frontal fibrosing alopecia: a unifying concept.
Topics: Adult; Age Distribution; Aged; Alopecia; Biopsy, Needle; Cohort Studies; Diagnosis, Differential; Di | 2010 |
Frontal fibrosing alopecia occurring on scalp vitiligo: report of four cases.
Topics: Adult; Aged; Alopecia; Female; Fibrosis; Humans; Middle Aged; Scalp; Scalp Dermatoses; Vitiligo | 2011 |
The follicular triad: a pathological clue to the diagnosis of early frontal fibrosing alopecia.
Topics: Alopecia; Early Diagnosis; Fibrosis; Forehead; Humans; Lichen Planus; Middle Aged; Scalp | 2012 |
Nonhealing ulcers on the scalp. Diagnosis: Lupus erythematosus panniculitis (LEP).
Topics: Diagnosis, Differential; Female; Fibrosis; Humans; Inflammation; Lymphocytes; Middle Aged; Panniculi | 2011 |
Frontal fibrosing alopecia: a retrospective review of 19 patients seen at Duke University.
Topics: 5-alpha Reductase Inhibitors; Adult; Aged; Alopecia; Anti-Bacterial Agents; Azasteroids; Cicatrix; D | 2013 |
[Kossard frontal fibrosing alopecia in a man].
Topics: Aged; Alopecia; Biopsy; Fibrosis; Hair Follicle; Humans; Lichen Planus; Male; Scalp; Sex Factors | 2002 |
Postmenopausal frontal fibrosing alopecia.
Topics: Adult; Aged; Alopecia; Biopsy; Female; Fibrosis; Glucocorticoids; Humans; Postmenopause; Scalp | 2003 |
Frontal fibrosing alopecia in postmenopausal women.
Topics: Aged; Alopecia; Eyebrows; Female; Fibrosis; Forehead; Humans; Middle Aged; Postmenopause; Scalp | 2005 |
Frontal fibrosing alopecia developing after hair transplantation for androgenetic alopecia.
Topics: Aged; Alopecia; Fibrosis; Hair; Humans; Male; Postoperative Complications; Scalp | 2005 |
[Frontal fibrosing alopecia is not always post-menopausal].
Topics: Adolescent; Adult; Age of Onset; Aged; Alopecia; Disease Progression; Female; Fibrosis; Humans; Midd | 2005 |
[Two cases of frontal fibrosing alopecia in postmenopausal women].
Topics: Administration, Topical; Adrenal Cortex Hormones; Aged; Alopecia; Female; Fibrosis; Forehead; Humans | 2004 |
Female pattern hair loss and its relationship to permanent/cicatricial alopecia: a new perspective.
Topics: Alopecia; Black or African American; Cicatrix; Female; Fibrosis; Hair Follicle; Humans; Scalp | 2005 |
Frontal fibrosing alopecia versus lichen planopilaris: a clinicopathological study.
Topics: Aged; Aged, 80 and over; Alopecia; Apoptosis; Biopsy; Female; Fibrosis; Fluorescent Antibody Techniq | 2006 |
[Hair darkening close to a patch of frontal fibrosing alopecia].
Topics: Aged; Alopecia; Female; Fibrosis; Hair Color; Humans; Scalp | 2006 |
Successful surgical management of lipoedematous alopecia.
Topics: Aged; Alopecia; Female; Fibrosis; Humans; Scalp; Scalp Dermatoses; Skin; Subcutaneous Fat | 2008 |
Postmenopausal frontal fibrosing alopecia. Scarring alopecia in a pattern distribution.
Topics: Aged; Alopecia; Cicatrix; Female; Fibrosis; Humans; Middle Aged; Postmenopause; Scalp | 1994 |
Diagnostic and predictive value of horizontal sections of scalp biopsy specimens in male pattern androgenetic alopecia.
Topics: Administration, Cutaneous; Adolescent; Adult; Aged; Alopecia; Biopsy; Collagen; Female; Fibrosis; Fo | 1993 |
Postmenopausal frontal fibrosing alopecia: a frontal variant of lichen planopilaris.
Topics: Administration, Oral; Aged; Aged, 80 and over; Alopecia; Antimalarials; Biopsy; Chloroquine; Dermato | 1997 |
Fibrosis in galeo pericranial flaps.
Topics: Fascia; Fibrosis; Humans; Oropharyngeal Neoplasms; Oropharynx; Scalp; Surgical Flaps | 1997 |
Imaging of nasopharyngeal carcinoma with Tc-99m MIBI.
Topics: Adult; Aged; Carcinoma; Diagnosis, Differential; Female; Fibrosis; Head; Humans; Male; Middle Aged; | 1998 |
[Lichen planopilaris simulating postmenopausal frontal fibrosing alopecia (Kossard)].
Topics: Aged; Alopecia; Diagnosis, Differential; Female; Fibrosis; Hair Follicle; Humans; Lichen Planus; Mid | 1998 |
A peculiar pattern of alopecia.
Topics: Alopecia; Female; Fibrosis; Hair Follicle; Humans; Middle Aged; Postmenopause; Scalp; Scalp Dermatos | 2001 |
Buschke-Ollendorff syndrome of the scalp: histologic and ultrastructural findings.
Topics: Collagen; Elastic Tissue; Fibrosis; Humans; Male; Middle Aged; Nevus; Osteopoikilosis; Pedigree; Sca | 1991 |
Lichen planopilaris: a clinicopathologic study.
Topics: Adult; Aged; Epidermis; Epithelium; Female; Fibrosis; Humans; Hyperplasia; Lichen Planus; Male; Midd | 1990 |