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Thalidomide: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects.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.
Excerpt | Relevance | Reference |
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" 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." | 5.41 | A 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." | 3.96 | Refractory 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." | 1.35 | Acute 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) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 1 (7.69) | 18.2507 |
2000's | 1 (7.69) | 29.6817 |
2010's | 2 (15.38) | 24.3611 |
2020's | 9 (69.23) | 2.80 |
Authors | Studies |
---|---|
Dorgham, N | 1 |
Crasto, D | 1 |
Skopit, S | 1 |
Megna, M | 1 |
Potestio, L | 1 |
Di Caprio, N | 1 |
Tajani, A | 1 |
Fabbrocini, G | 1 |
Annunziata, A | 1 |
Maione, V | 3 |
Bettolini, L | 3 |
Venturuzzo, A | 3 |
Tonon, F | 3 |
Battocchio, S | 3 |
Calzavara-Pinton, P | 3 |
Zhang, L | 1 |
Gebauer, K | 1 |
Carrascosa de Lome, R | 1 |
Conde Montero, E | 1 |
de la Cueva Dobao, P | 1 |
Magdaleno-Tapial, J | 1 |
Valenzuela-Oñate, C | 1 |
Alonso-Carpio, M | 1 |
García-Legaz, M | 1 |
Alegre-de Miquel, V | 1 |
Zaragoza-Ninet, MG | 1 |
Zaragoza-Ninet, V | 1 |
Wang, WM | 1 |
Shu, D | 1 |
Jiang, YY | 1 |
Jin, HZ | 1 |
Kt, S | 1 |
Thakur, V | 1 |
Narang, T | 1 |
Dogra, S | 1 |
Handa, S | 1 |
Wilsmann-Theis, D | 1 |
Kromer, C | 1 |
Gerdes, S | 1 |
Linker, C | 1 |
Magnolo, N | 1 |
Sabat, R | 1 |
Reich, K | 1 |
Mössner, R | 1 |
Mathieu, S | 1 |
Soubrier, M | 1 |
Tournadre, A | 1 |
Dubost, JJ | 1 |
Nofal, A | 1 |
Assaf, M | 1 |
Elakad, R | 1 |
Fawzy, M | 1 |
Nofal, E | 1 |
Momin, SB | 1 |
Del Rosso, JQ | 1 |
Michaels, B | 1 |
Mobini, N | 1 |
Couppié, P | 1 |
Sainte-Marie, D | 1 |
About, V | 1 |
Heid, E | 1 |
Pradinaud, R | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
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 2 | 21 participants (Actual) | Interventional | 2018-11-29 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
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)
Intervention | Percent change (Median) |
---|---|
Full Analysis Set - LOCF | -76.3 |
Per Protocol Set (PPS) | -79.82 |
"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).
Intervention | DLQI Score (Median) | ||
---|---|---|---|
Visit 2 - Baseline | Visit 4 - Week 12 | Visit 5 - End of Study - Week 20 | |
Full Analysis Set (FAS) | 8.50 | 2.50 | 2.00 |
Per Protocol Set (PPS) | 8.00 | 2.50 | 2.00 |
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).
Intervention | Participants (Count of Participants) | ||
---|---|---|---|
Visit 3 - Week 4 | Visit 4 - Week 12 | Visit 5 - End of Study - Week 20 | |
Full Analysis Set (FAS) | 7 | 12 | 13 |
Per Protocol Set (PPS) | 7 | 12 | 13 |
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).
Intervention | Participants (Count of Participants) | ||
---|---|---|---|
Visit 3 - Week 4 | Visit 4 - Week 12 | Visit 5 - End of Study - Week 20 | |
Full Analysis Set (FAS) | 2 | 6 | 3 |
Per Protocol Set (PPS) | 2 | 6 | 3 |
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).
Intervention | Participants (Count of Participants) | |||||
---|---|---|---|---|---|---|
Pustules count 50: Visit 3 - Week 4 | Pustules count 50: Visit 4 - Week 12 | Pustules count 50: Visit 5-End of Study- Week 20 | Pustules count 75: Visit 3 - Week 4 | Pustules count 75: Visit 4 - Week 12 | Pustules count 75: Visit 5-End of Study- Week 20 | |
Full Analysis Set (FAS) | 13 | 18 | 16 | 8 | 14 | 12 |
Per Protocol Set (PPS) | 14 | 17 | 16 | 9 | 14 | 12 |
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.
Intervention | PPPASI Score (Median) | |
---|---|---|
Visit 2 - Baseline | Visit 5 - End of Study - Week 20 | |
Full Analysis Set - LOCF | 16.50 | 8.10 |
Full Analysis Set (FAS) | 16.50 | 7.65 |
Per Protocol Set (PPS) | 15.85 | 7.65 |
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).
Intervention | PASI Score (Median) | |||
---|---|---|---|---|
Visit 2 - Baseline | Visit 3 - Week 4 | Visit 4 - Week 12 | Visit 5-End of Study-Week 20 | |
Per Protocol Set (PPS) | 3.85 | 2.27 | 0.5 | 0.95 |
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).
Intervention | Units on a scale (Median) | |||
---|---|---|---|---|
Visit 2 - Baseline | Visit 3 - Week 4 | Visit 4 - Week 12 | Visit 5 - End of Study - Week 20 | |
Full Analysis Set (FAS) | 44.0 | 4.0 | 2.0 | 9.0 |
Per Protocol Set (PPS) | 37.5 | 3.0 | 1.5 | 7.5 |
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).
Intervention | Units on a scale (Median) | |||
---|---|---|---|---|
Visit 2 - Baseline | Visit 3 - Week 4 | Visit 4 - Week 12 | Visit 5 - End of Study - Week 20 | |
Full Analysis Set (FAS) | 31.0 | 2.0 | 25.0 | 12.0 |
Per Protocol Set (PPS) | 29.5 | 11.0 | 24.0 | 11.5 |
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).
Intervention | Participants (Count of Participants) | ||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Visit 3 - Week 472520894 | Visit 4 - Week 1272520894 | Visit 5 - End of Study - Week 2072520894 | |||||||||||||||||||
5 fair | 6 worse | 1 excellent | 2 good | 3 slight | 4 unchanged | 0 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 |
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).
Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Visit 2 - Baseline72520890 | Visit 2 - Baseline72520891 | Visit 3 - Week 472520890 | Visit 3 - Week 472520891 | Visit 4 - Week 1272520890 | Visit 4 - Week 1272520891 | Visit 5 - End of Study - Week 2072520890 | Visit 5 - End of Study - Week 2072520891 | |||||||||||||||||||||||||||||||||
0 clear | 1 almost clear | 2 mild | 3 moderate | 4 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 |
1 trial available for thalidomide and Bullous Dermatoses
Article | Year |
---|---|
A multicentre open-label study of apremilast in palmoplantar pustulosis (APLANTUS).
Topics: Humans; Phosphodiesterase 4 Inhibitors; Psoriasis; Severity of Illness Index; Skin Diseases, Vesicul | 2021 |
12 other studies available for thalidomide and Bullous Dermatoses
Article | Year |
---|---|
Successful Treatment of Palmoplantar Pustulosis With Apremilast.
Topics: Acute Disease; Humans; Psoriasis; Skin Diseases, Vesiculobullous; Thalidomide | 2021 |
Acrodermatitis continua of Hallopeau: Is apremilast an efficacious treatment option?
Topics: Acrodermatitis; Exanthema; Humans; Psoriasis; Skin Diseases, Vesiculobullous; Thalidomide | 2022 |
Efficacy of apremilast in a case of resistant linear IgA bullous disease.
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.
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.
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.
Topics: Humans; Immunoglobulin A; Linear IgA Bullous Dermatosis; Skin Diseases, Vesiculobullous; Thalidomide | 2023 |
Subcorneal pustular dermatosis treated successfully with apremilast.
Topics: Humans; Skin; Skin Diseases, Vesiculobullous; Thalidomide | 2023 |
Refractory palmoplantar pustulosis succesfully treated with apremilast.
Topics: Arthritis, Psoriatic; Humans; Psoriasis; Skin Diseases, Vesiculobullous; Thalidomide | 2020 |
Improvement of recalcitrant Sneddon-Wilkinson disease with apremilast.
Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Female; Humans; Skin Diseases, Vesiculobullous; Thali | 2020 |
Recurrent generalized pustular psoriasis possibly triggered by apremilast.
Topics: Acute Disease; Humans; Psoriasis; Skin Diseases, Vesiculobullous; Thalidomide | 2020 |
Apremilast in treatment of palmoplantar pustulosis - a case series.
Topics: Exanthema; Humans; Psoriasis; Skin Diseases, Vesiculobullous; Thalidomide | 2021 |
Neutrophilic dermatosis of the dorsal hands during thalidomide treatment.
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?
Topics: Antineoplastic Agents; Hand Dermatoses; Humans; Male; Neutrophils; Skin Diseases, Vesiculobullous; T | 2015 |
Acute generalized exanthematous pustulosis: an enigmatic drug-induced reaction.
Topics: Acute Disease; Aged; Dexamethasone; Diagnosis, Differential; Drug Eruptions; Exanthema; Humans; Male | 2009 |
[Bullous erythema nodosum leprosum. A case report in French Guiana].
Topics: Adult; Diagnosis, Differential; Erythema Nodosum; French Guiana; Humans; Leprostatic Agents; Leprosy | 1998 |