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
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Siriraj Hospital
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- Change of Investigator's Global Assessment score (IGA) after treatment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.)
Intervention: Placebo (Drug)
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.)
Intervention: 0.25% Desoximetasone cream (Topoxy®) (Drug)
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.)
Intervention: 0.25% Desoximetasone cream (Topicorte®) (Drug)
Outcomes
Primary Outcomes
Change of Investigator's Global Assessment score (IGA) after treatment
Time Frame: 2, 4 and 8 weeks
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)
Secondary Outcomes
- Side effects after treatment(2, 4 and 8 weeks)
- Change of total sign score (TSS) after treatment(2, 4 and 8 weeks)
- Number of patients with clear or absent disease after treatment(8 weeks)
Investigators
Pichanee Chaweekulrat
M.D.
Siriraj Hospital