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

Siriraj Hospital

Status and phase: Unknown; Phase 3

Conditions: Scalp Psoriasis

Treatments: Drug: 0.25% Desoximetasone cream (Topicorte®); Drug: Placebo; Drug: 0.25% Desoximetasone cream (Topoxy®)

Study type: Interventional

Funder types: Other

Identifiers

NCT02749656

SPS01

Details and patient eligibility

About

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.

Enrollment: 105 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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105 participants in 3 patient groups, including a placebo group

0.25% Desoximetasone cream (Topoxy®)

Experimental group

Description:

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.)

Treatment:

Drug: 0.25% Desoximetasone cream (Topoxy®)

0.25% Desoximetasone cream (Topicorte®)

Active Comparator group

Description:

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.)

Treatment:

Drug: 0.25% Desoximetasone cream (Topicorte®)

Placebo

Placebo Comparator group

Description:

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.)

Treatment:

Drug: Placebo