Page last updated: 2024-11-05

thalidomide and Bullous Dermatoses

thalidomide has been researched along with Bullous Dermatoses in 13 studies

Thalidomide: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects. It has been reintroduced and used for a number of immunological and inflammatory disorders. Thalidomide displays immunosuppressive and anti-angiogenic activity. It inhibits release of TUMOR NECROSIS FACTOR-ALPHA from monocytes, and modulates other cytokine action.
thalidomide : A racemate comprising equimolar amounts of R- and S-thalidomide.
2-(2,6-dioxopiperidin-3-yl)-1H-isoindole-1,3(2H)-dione : A dicarboximide that is isoindole-1,3(2H)-dione in which the hydrogen attached to the nitrogen is substituted by a 2,6-dioxopiperidin-3-yl group.

Research Excerpts

ExcerptRelevanceReference
" Apremilast is a phosphodiesterase 4 inhibitor that has proven effective in the therapy of psoriasis, psoriatic arthritis and in oral ulcers associated with Behcet's disease."5.41A multicentre open-label study of apremilast in palmoplantar pustulosis (APLANTUS). ( Gerdes, S; Kromer, C; Linker, C; Magnolo, N; Mössner, R; Reich, K; Sabat, R; Wilsmann-Theis, D, 2021)
" Apremilast is an oral phosphodiesterase-4 inhibitor which is approved for the treatment of chronic plaque psoriasis and psoriatic arthritis."3.96Refractory palmoplantar pustulosis succesfully treated with apremilast. ( Carrascosa de Lome, R; Conde Montero, E; de la Cueva Dobao, P, 2020)
"Acute generalized exanthematous pustulosis (AGEP) is a diffuse pustular disorder that is primarily drug induced and characterized by acute, extensive, small, nonfollicular, sterile pustules that usually begin in intertriginous folds with widespread edema and erythema."1.35Acute generalized exanthematous pustulosis: an enigmatic drug-induced reaction. ( Del Rosso, JQ; Michaels, B; Mobini, N; Momin, SB, 2009)
"Treatment with thalidomide led to rapid regression."1.30[Bullous erythema nodosum leprosum. A case report in French Guiana]. ( About, V; Couppié, P; Heid, E; Pradinaud, R; Sainte-Marie, D, 1998)

Research

Studies (13)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's1 (7.69)18.2507
2000's1 (7.69)29.6817
2010's2 (15.38)24.3611
2020's9 (69.23)2.80

Authors

AuthorsStudies
Dorgham, N1
Crasto, D1
Skopit, S1
Megna, M1
Potestio, L1
Di Caprio, N1
Tajani, A1
Fabbrocini, G1
Annunziata, A1
Maione, V3
Bettolini, L3
Venturuzzo, A3
Tonon, F3
Battocchio, S3
Calzavara-Pinton, P3
Zhang, L1
Gebauer, K1
Carrascosa de Lome, R1
Conde Montero, E1
de la Cueva Dobao, P1
Magdaleno-Tapial, J1
Valenzuela-Oñate, C1
Alonso-Carpio, M1
García-Legaz, M1
Alegre-de Miquel, V1
Zaragoza-Ninet, MG1
Zaragoza-Ninet, V1
Wang, WM1
Shu, D1
Jiang, YY1
Jin, HZ1
Kt, S1
Thakur, V1
Narang, T1
Dogra, S1
Handa, S1
Wilsmann-Theis, D1
Kromer, C1
Gerdes, S1
Linker, C1
Magnolo, N1
Sabat, R1
Reich, K1
Mössner, R1
Mathieu, S1
Soubrier, M1
Tournadre, A1
Dubost, JJ1
Nofal, A1
Assaf, M1
Elakad, R1
Fawzy, M1
Nofal, E1
Momin, SB1
Del Rosso, JQ1
Michaels, B1
Mobini, N1
Couppié, P1
Sainte-Marie, D1
About, V1
Heid, E1
Pradinaud, R1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Multicenter, Open Label, Single-arm Pilot Study to Evaluate the Efficacy and Safety of Oral Apremilast in Patients With Moderate to Severe Palmoplantar Pustulosis (PPP) (APLANTUS)[NCT04572997]Phase 221 participants (Actual)Interventional2018-11-29Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Pustules Count Percent Change From Baseline

Percentage change from baseline in Pustules count after 20 weeks of treatment with Apremilast (NCT04572997)
Timeframe: At Visit 2 (Baseline) and Visit 5 (End of Study - Week 20)

InterventionPercent change (Median)
Full Analysis Set - LOCF-76.3
Per Protocol Set (PPS)-79.82

Dermatology Life Quality Index (DLQI)

"The DLQI is a dermatology-specific quality of life instrument designed to assess the impact of a disease on the patient's daily life which is also validated for PPP. It is a 10-item questionnaire and can be used to assess 6 different aspects: symptoms and feelings, leisure, daily activities, work or school performance, personal relationship and treatment. The DLQI was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life was impaired.~Meaning of DLQI scores:~0 to 1 = No effect at all on patient's life~2 to 5 = Small effect on patient's life~6 to 10 = Moderate effect on patient's life~11 to 20 = Very large effect on patient's life~21 to 30 = Extremely large effect on patient's life" (NCT04572997)
Timeframe: At Visit 2 (Baseline), Visit 4 (Week 12) and Visit 5 (Week 20).

,
InterventionDLQI Score (Median)
Visit 2 - BaselineVisit 4 - Week 12Visit 5 - End of Study - Week 20
Full Analysis Set (FAS)8.502.502.00
Per Protocol Set (PPS)8.002.502.00

Number of Participants With PPPASI 50 Response

PPPASI 50 response defined as a 50% decrease in PPPASI from baseline. (NCT04572997)
Timeframe: At Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (Week 20).

,
InterventionParticipants (Count of Participants)
Visit 3 - Week 4Visit 4 - Week 12Visit 5 - End of Study - Week 20
Full Analysis Set (FAS)71213
Per Protocol Set (PPS)71213

Number of Participants With PPPASI 75 Response

PPPASI 75 response defined as a 75% decrease in PPPASI from baseline. (NCT04572997)
Timeframe: At Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (Week 20).

,
InterventionParticipants (Count of Participants)
Visit 3 - Week 4Visit 4 - Week 12Visit 5 - End of Study - Week 20
Full Analysis Set (FAS)263
Per Protocol Set (PPS)263

Number of Participants With Pustules Count 50 and 75 Response

Patients experiencing a 50% and 75% decrease in Pustules count from baseline (NCT04572997)
Timeframe: At Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (End of Study-Week 20).

,
InterventionParticipants (Count of Participants)
Pustules count 50: Visit 3 - Week 4Pustules count 50: Visit 4 - Week 12Pustules count 50: Visit 5-End of Study- Week 20Pustules count 75: Visit 3 - Week 4Pustules count 75: Visit 4 - Week 12Pustules count 75: Visit 5-End of Study- Week 20
Full Analysis Set (FAS)13181681412
Per Protocol Set (PPS)14171691412

Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI) at Week 20 Compared With Baseline

The PPPASI assess palms of hands and soles of feet for psoriasis involvement. The PPPASI score range from 0-72, with higher scores indicating more severe disease. (NCT04572997)
Timeframe: PPPASI Score at baseline and Week 20.

,,
InterventionPPPASI Score (Median)
Visit 2 - BaselineVisit 5 - End of Study - Week 20
Full Analysis Set - LOCF16.508.10
Full Analysis Set (FAS)16.507.65
Per Protocol Set (PPS)15.857.65

Psoriasis Area and Severity Index (PASI)

The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. (NCT04572997)
Timeframe: At Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (End of Study - Week 20).

InterventionPASI Score (Median)
Visit 2 - BaselineVisit 3 - Week 4Visit 4 - Week 12Visit 5-End of Study-Week 20
Per Protocol Set (PPS)3.852.270.50.95

Visual Analogue Scale (VAS) Discomfort/Pain

VAS was used to assess discomfort/pain. The patient was asked to place a vertical stroke on a 100 mm VAS on which the left-hand boundary represented no discomfort/pain (at 0 mm), and the right-hand boundary (at 100 mm) represented discomfort/pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded, with higher values indicating more discomfort/pain (worse conditions). (NCT04572997)
Timeframe: At Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (End of Study - Week 20).

,
InterventionUnits on a scale (Median)
Visit 2 - BaselineVisit 3 - Week 4Visit 4 - Week 12Visit 5 - End of Study - Week 20
Full Analysis Set (FAS)44.04.02.09.0
Per Protocol Set (PPS)37.53.01.57.5

Visual Analogue Scale (VAS) Pruritus/Itch

VAS was used to assess pruritus/itch. The patient was asked to place a vertical stroke on a 100 mm VAS on which the left-hand boundary (at 0 mm) represented no pruritus/itch, and the right-hand boundary (at 100 mm) represented pruritus/itch as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded, with higher values indicating more pruritus/itch (worse outcomes). (NCT04572997)
Timeframe: At Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (End of Study - Week 20).

,
InterventionUnits on a scale (Median)
Visit 2 - BaselineVisit 3 - Week 4Visit 4 - Week 12Visit 5 - End of Study - Week 20
Full Analysis Set (FAS)31.02.025.012.0
Per Protocol Set (PPS)29.511.024.011.5

Dynamic H&F PGA

The dynamic H&F PGA describes the global improvement compared with baseline. It relies on the physician's memory of the baseline severity to evaluate the level of alteration. The categories vary between 0 (cleared) and 6 (worse). (NCT04572997)
Timeframe: At Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (End of Study - Week 20).

InterventionParticipants (Count of Participants)
Visit 3 - Week 472520894Visit 4 - Week 1272520894Visit 5 - End of Study - Week 2072520894
5 fair6 worse1 excellent2 good3 slight4 unchanged0 cleared
Per Protocol Set (PPS)3
Per Protocol Set (PPS)4
Per Protocol Set (PPS)7
Per Protocol Set (PPS)0
Per Protocol Set (PPS)5
Per Protocol Set (PPS)2
Per Protocol Set (PPS)6

Hand and Feet Physician Global Assessment (H&F PGA)

The H&F PGA describes the severity of psoriasis on the hands and/or feet using five categories ranging from 0 (clear) to 4 (severe). (NCT04572997)
Timeframe: At Visit 2 (Baseline), Visit 3 (Week 4) , Visit 4 (Week 12) and Visit 5 (Week 20).

InterventionParticipants (Count of Participants)
Visit 2 - Baseline72520890Visit 2 - Baseline72520891Visit 3 - Week 472520890Visit 3 - Week 472520891Visit 4 - Week 1272520890Visit 4 - Week 1272520891Visit 5 - End of Study - Week 2072520890Visit 5 - End of Study - Week 2072520891
0 clear1 almost clear2 mild3 moderate4 severe
Full Analysis Set (FAS)0
Per Protocol Set (PPS)0
Full Analysis Set (FAS)2
Per Protocol Set (PPS)2
Full Analysis Set (FAS)19
Per Protocol Set (PPS)18
Full Analysis Set (FAS)1
Full Analysis Set (FAS)10
Full Analysis Set (FAS)9
Full Analysis Set (FAS)3
Per Protocol Set (PPS)3
Per Protocol Set (PPS)9
Full Analysis Set (FAS)8
Per Protocol Set (PPS)1
Per Protocol Set (PPS)10
Per Protocol Set (PPS)8

Trials

1 trial available for thalidomide and Bullous Dermatoses

ArticleYear
A multicentre open-label study of apremilast in palmoplantar pustulosis (APLANTUS).
    Journal of the European Academy of Dermatology and Venereology : JEADV, 2021, Volume: 35, Issue:10

    Topics: Humans; Phosphodiesterase 4 Inhibitors; Psoriasis; Severity of Illness Index; Skin Diseases, Vesicul

2021

Other Studies

12 other studies available for thalidomide and Bullous Dermatoses

ArticleYear
Successful Treatment of Palmoplantar Pustulosis With Apremilast.
    Journal of drugs in dermatology : JDD, 2021, Nov-01, Volume: 20, Issue:11

    Topics: Acute Disease; Humans; Psoriasis; Skin Diseases, Vesiculobullous; Thalidomide

2021
Acrodermatitis continua of Hallopeau: Is apremilast an efficacious treatment option?
    Dermatologic therapy, 2022, Volume: 35, Issue:5

    Topics: Acrodermatitis; Exanthema; Humans; Psoriasis; Skin Diseases, Vesiculobullous; Thalidomide

2022
Efficacy of apremilast in a case of resistant linear IgA bullous disease.
    International journal of dermatology, 2023, Volume: 62, Issue:5

    Topics: Humans; Immunoglobulin A; Linear IgA Bullous Dermatosis; Skin Diseases, Vesiculobullous; Thalidomide

2023
Efficacy of apremilast in a case of resistant linear IgA bullous disease.
    International journal of dermatology, 2023, Volume: 62, Issue:5

    Topics: Humans; Immunoglobulin A; Linear IgA Bullous Dermatosis; Skin Diseases, Vesiculobullous; Thalidomide

2023
Efficacy of apremilast in a case of resistant linear IgA bullous disease.
    International journal of dermatology, 2023, Volume: 62, Issue:5

    Topics: Humans; Immunoglobulin A; Linear IgA Bullous Dermatosis; Skin Diseases, Vesiculobullous; Thalidomide

2023
Efficacy of apremilast in a case of resistant linear IgA bullous disease.
    International journal of dermatology, 2023, Volume: 62, Issue:5

    Topics: Humans; Immunoglobulin A; Linear IgA Bullous Dermatosis; Skin Diseases, Vesiculobullous; Thalidomide

2023
Subcorneal pustular dermatosis treated successfully with apremilast.
    The Australasian journal of dermatology, 2023, Volume: 64, Issue:3

    Topics: Humans; Skin; Skin Diseases, Vesiculobullous; Thalidomide

2023
Refractory palmoplantar pustulosis succesfully treated with apremilast.
    Dermatologic therapy, 2020, Volume: 33, Issue:2

    Topics: Arthritis, Psoriatic; Humans; Psoriasis; Skin Diseases, Vesiculobullous; Thalidomide

2020
Improvement of recalcitrant Sneddon-Wilkinson disease with apremilast.
    The Australasian journal of dermatology, 2020, Volume: 61, Issue:2

    Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Female; Humans; Skin Diseases, Vesiculobullous; Thali

2020
Recurrent generalized pustular psoriasis possibly triggered by apremilast.
    Chinese medical journal, 2020, May-20, Volume: 133, Issue:10

    Topics: Acute Disease; Humans; Psoriasis; Skin Diseases, Vesiculobullous; Thalidomide

2020
Apremilast in treatment of palmoplantar pustulosis - a case series.
    International journal of dermatology, 2021, Volume: 60, Issue:6

    Topics: Exanthema; Humans; Psoriasis; Skin Diseases, Vesiculobullous; Thalidomide

2021
Neutrophilic dermatosis of the dorsal hands during thalidomide treatment.
    International journal of dermatology, 2014, Volume: 53, Issue:9

    Topics: Aged; Antineoplastic Agents; Hand Dermatoses; Humans; Male; Multiple Myeloma; Neutrophils; Skin Dise

2014
Neutrophilic dermatosis of the dorsal hands: a localized variant of Sweet's syndrome or a distinct entity?
    International journal of dermatology, 2015, Volume: 54, Issue:2

    Topics: Antineoplastic Agents; Hand Dermatoses; Humans; Male; Neutrophils; Skin Diseases, Vesiculobullous; T

2015
Acute generalized exanthematous pustulosis: an enigmatic drug-induced reaction.
    Cutis, 2009, Volume: 83, Issue:6

    Topics: Acute Disease; Aged; Dexamethasone; Diagnosis, Differential; Drug Eruptions; Exanthema; Humans; Male

2009
[Bullous erythema nodosum leprosum. A case report in French Guiana].
    Annales de dermatologie et de venereologie, 1998, Volume: 125, Issue:3

    Topics: Adult; Diagnosis, Differential; Erythema Nodosum; French Guiana; Humans; Leprostatic Agents; Leprosy

1998