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| Name | Class |
|---|---|
| SPS MEDICAL CO.,LTD. | UNKNOWN |
| Siriraj clinical research center | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.25% Desoximetasone cream (Topoxy®) | Experimental | 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.) |
|
| 0.25% Desoximetasone cream (Topicorte®) | Active Comparator | 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.) |
|
| Placebo | Placebo Comparator | 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.) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.25% Desoximetasone cream (Topoxy®) | Drug | apply on the scalp psoriasis lesion twice a day |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Treated with these medications before including in the study
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pichanee Chaweekulrat, M.D. | Contact | +6686-886-5277 | pizzu43087@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Associated. Prof. Chanisada Wongpraparut, M.D. | Mahidol University | Principal Investigator |
| Assist. Prof. Leena Chularojmontri, M.D. | Mahidol University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of dermatology Faculty of Medicine Siriraj Hospital | Recruiting | Bangkok | 10900 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24301242 | Background | Kircik L, Lebwohl MG, Del Rosso JQ, Bagel J, Stein Gold L, Weiss JS. Clinical study results of desoximetasone spray, 0.25% in moderate to severe plaque psoriasis. J Drugs Dermatol. 2013 Dec;12(12):1404-10. | |
| 800971 | Background | Kuokkanen K. Comparison of 0.25% desoxymethasone ointment with 0.05% fluocinonide ointment in psoriasis. Curr Med Res Opin. 1976-1977;4(10):703-5. doi: 10.1185/03007997609112005. |
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| ID | Term |
|---|---|
| D003899 | Desoximetasone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| 0.25% Desoximetasone cream (Topicorte®) | Drug | apply on the scalp psoriasis lesion twice a day |
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| Placebo | Drug | apply on the scalp psoriasis lesion twice a day |
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| 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 |
| Assist. Prof. Narumol Silpa-archa, M.D. |
| Mahidol University |
| Study Chair |
| Pichanee Chaweekulrat, M.D. | Mahidol University | Study Chair |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003907 | Dexamethasone |
| D013259 | Steroids, Fluorinated |