Clinical trial NCT02749656: Efficacy and Safety of 0.25% Desoximetasone Cream (Topoxy®) in the Treatment of Scalp Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Scalp Psoriasis
Keywords: Scalp psoriasis
0.25% Desoximetasone cream
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
Collaborators: name: SPS MEDICAL CO.,LTD.
name: Siriraj clinical research center
First posted: 2016-04-25
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
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:

1. 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
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

Primary outcomes:
measure: Change of Investigator's Global Assessment score (IGA) after treatment
timeFrame: 2, 4 and 8 weeks
Secondary outcomes:
measure: Change of total sign score (TSS) after treatment
timeFrame: 2, 4 and 8 weeks
measure: Number of patients with clear or absent disease after treatment
timeFrame: 8 weeks
measure: Side effects after treatment
timeFrame: 2, 4 and 8 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of dermatology Faculty of Medicine Siriraj Hospital
Study officials:
affiliation: Mahidol University
name: Associated. Prof. Chanisada Wongpraparut, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mahidol University
name: Assist. Prof. Leena Chularojmontri, M.D.
role: STUDY_CHAIR
affiliation: Mahidol University
name: Assist. Prof. Narumol Silpa-archa, M.D.
role: STUDY_CHAIR
affiliation: Mahidol University
name: Pichanee Chaweekulrat, M.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.