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

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Siriraj Hospital
• Collaborators: Siriraj clinical research center; SPS MEDICAL CO.,LTD.
• Treatments: Desoximetasone

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