Efficacy and Safety of 0.25% Desoximetasone Cream (Topoxy®) in the Treatment of Scalp Psoriasis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate efficacy and safety of 0.25% Desoximetasone cream (Topoxy®) compare with 0.25% Desoximetasone cream (Topicorte®) in the treatment of scalp psoriasis.

Official Title
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A Randomized Control Trial of Efficacy and Safety of 0.25% Desoximetasone Cream (Topoxy®) Compared With 0.25% Desoximetasone Cream (Topicorte®) in the Treatment of Scalp Psoriasis

Conditions
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Scalp Psoriasis

Intervention / Treatment
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* Drug: 0.25% Desoximetasone cream (Topoxy®)
* Drug: 0.25% Desoximetasone cream (Topicorte®)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Diagnosed with scalp psoriasis by dermatologist Has scalp psoriasis Involve ≥ 10% of total scalp area and also has clinical signs, or a previous diagnosis, of psoriasis on the trunk and/or limbs Total severity of scalp psoriasis should be graded in mild to very severe according to Investigator's Global Assessment score (IGA) Clinical signs (redness, thickness, scaliness) should be scored as Moderate for at least 1 sign and slight on each of the other two signs All participants agree to participate in the study and already complete and sign consent form Exclusion Criteria: Treated with these medications before including in the study Topical corticosteroid for scalp psoriasis (except emollients and shampoo) within 2 weeks Very potent topical corticosteroids for psoriasis on other area or Narrow band Ultraviolet B (NB-UVB) within 2 weeks Oral psoralen plus Ultraviolet A (PUVA) or oral medication (Methotrexate, Acitretin, Cyclosporine) within 4 weeks Biologic agents or concomitant medication that could affect scalp psoriasis (Beta- blockers, Antimalarial drugs, Lithium ) within 6 months Has skin infection or atrophic skin on the scalp Has history of allergic reaction or hypersensitivity to 0.25% Desoximetasone Female participants with pregnancy or in lactation period Participants who unable to come for follow-up visits at hospital Participants with other underlying disease e.g. diabetes mellitus, hypertension, thyroid disease Vulnerable subject e.g. illiterate person

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.25% Desoximetasone cream (Topoxy®)<br>0.25% Desoximetasone cream (Topoxy®): apply on scalp psoriasis lesion twice a day for 8 weeks. (Tar shampoo will be given to all participants. The Shampoo should be applied on wet scalp every other day, then massage and allow shampoo to remain on the scalp for 5 minutes, after that rinse off by water.) | Drug: 0.25% Desoximetasone cream (Topoxy®)<br>* apply on the scalp psoriasis lesion twice a day<br>* Other names: Topoxy®;|
| Active Comparator: 0.25% Desoximetasone cream (Topicorte®)<br>0.25% Desoximetasone cream (Topicorte®): apply on scalp psoriasis lesion twice a day for 8 weeks. (Tar shampoo will be given to all participants. The Shampoo should be applied on wet scalp every other day, then massage and allow shampoo to remain on the scalp for 5 minutes, after that rinse off by water.) | Drug: 0.25% Desoximetasone cream (Topicorte®)<br>* apply on the scalp psoriasis lesion twice a day<br>* Other names: Topicorte®;|
| Placebo Comparator: Placebo<br>Placebo: apply on scalp psoriasis lesion twice a day for 8 weeks. (Tar shampoo will be given to all participants. The Shampoo should be applied on wet scalp every other day, then massage and allow shampoo to remain on the scalp for 5 minutes, after that rinse off by water.) | Drug: Placebo<br>* apply on the scalp psoriasis lesion twice a day<br>* Other names: vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Investigator's Global Assessment score (IGA) after treatment | The Investigator's Global Assessment score (IGA) was recorded at the first visit and after treated 2,4 and 8 weeks with 0.25% Desoximetasone cream (Topoxy®), 0.25% Desoximetasone cream (Topicorte®) or placebo. The IGA score consisted of 6 points score (0 = absent disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease) | 2, 4 and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of total sign score (TSS) after treatment | The Total sign score (TSS) was recorded at the first visit and after treated 2,4 and 8 weeks with 0.25% Desoximetasone cream (Topoxy®), 0.25% Desoximetasone cream (Topicorte®) or placebo. The TSS score was the sum of 5-point rating scores for erythema, induration and scaling (0 = no sign, 1 = slight signs, 2 = moderate signs, 3 = severe signs and 4 = very severe signs) | 2, 4 and 8 weeks | 
| Number of patients with clear or absent disease after treatment | Number of patients with clear or absent disease were recorded after treated 8 weeks with 0.25% Desoximetasone cream (Topoxy®), 0.25% Desoximetasone cream (Topicorte®) or placebo. | 8 weeks | 
| Side effects after treatment | Cutaneous side effects (e.g. skin discomfort, skin atrophy, telangiectasia) from 0.25% Desoximetasone cream were recorded after treated 2, 4 and 8 weeks. The side effects were scored as 0 = none, 1 = mild, 2 = moderate, 3 = severe for skin discomfort, skin atrophy and telangiectasia. | 2, 4 and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scalp psoriasis, 0.25% Desoximetasone cream