Efficacy and Safety of 0.25% Desoximetasone Cream (Topoxy®) in the Treatment of Scalp Psoriasis
NCT ID: NCT02749656
Last Updated: 2017-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
105 participants
INTERVENTIONAL
2016-01-01
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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0.25% Desoximetasone cream (Topoxy®)
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 (Topoxy®)
apply on the scalp psoriasis lesion twice a day
0.25% Desoximetasone cream (Topicorte®)
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.)
0.25% Desoximetasone cream (Topicorte®)
apply on the scalp psoriasis lesion twice a day
Placebo
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.)
Placebo
apply on the scalp psoriasis lesion twice a day
Interventions
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0.25% Desoximetasone cream (Topoxy®)
apply on the scalp psoriasis lesion twice a day
0.25% Desoximetasone cream (Topicorte®)
apply on the scalp psoriasis lesion twice a day
Placebo
apply on the scalp psoriasis lesion twice a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with scalp psoriasis by dermatologist
3. 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
4. Total severity of scalp psoriasis should be graded in mild to very severe according to Investigator's Global Assessment score (IGA)
5. Clinical signs (redness, thickness, scaliness) should be scored as "Moderate" for at least 1 sign and "slight" on each of the other two signs
6. All participants agree to participate in the study and already complete and sign consent form
Exclusion Criteria
* 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
2. Has skin infection or atrophic skin on the scalp
3. Has history of allergic reaction or hypersensitivity to 0.25% Desoximetasone
4. Female participants with pregnancy or in lactation period
5. Participants who unable to come for follow-up visits at hospital
6. Participants with other underlying disease e.g. diabetes mellitus, hypertension, thyroid disease
7. Vulnerable subject e.g. illiterate person
18 Years
ALL
No
Sponsors
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SPS MEDICAL CO.,LTD.
UNKNOWN
Siriraj clinical research center
UNKNOWN
Siriraj Hospital
OTHER
Responsible Party
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Pichanee Chaweekulrat
M.D.
Principal Investigators
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Associated. Prof. Chanisada Wongpraparut, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mahidol University
Assist. Prof. Leena Chularojmontri, M.D.
Role: STUDY_CHAIR
Mahidol University
Assist. Prof. Narumol Silpa-archa, M.D.
Role: STUDY_CHAIR
Mahidol University
Pichanee Chaweekulrat, M.D.
Role: STUDY_CHAIR
Mahidol University
Locations
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Department of dermatology Faculty of Medicine Siriraj Hospital
Bangkok, , Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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SPS01
Identifier Type: -
Identifier Source: org_study_id
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