Trial | NCT02749656  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    desoximetasone ...

  • Study Participants

    105
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 Started
Jan 01
2016
Primary Completion
Jan 31
2018
Anticipated
Study Completion
Dec 31
2018
Anticipated
Last Update
May 01
2017

Drug 0.25% Desoximetasone cream (Topoxy®)

apply on the scalp psoriasis lesion twice a day

  • Other names: Topoxy®

Drug 0.25% Desoximetasone cream (Topicorte®)

apply on the scalp psoriasis lesion twice a day

  • Other names: Topicorte®

Drug Placebo

apply on the scalp psoriasis lesion twice a day

  • Other names: vehicle

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.)

Criteria 

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
No Results Posted