Scalp Psoriasis
Conditions
Keywords
Scalp psoriasis, 0.25% Desoximetasone cream
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.
Interventions
DRUG0.25% Desoximetasone cream (Topoxy®)
apply on the scalp psoriasis lesion twice a day
DRUG0.25% Desoximetasone cream (Topicorte®)
apply on the scalp psoriasis lesion twice a day
DRUGPlacebo
apply on the scalp psoriasis lesion twice a day
Sponsors
SPS MEDICAL CO.,LTD.
Siriraj clinical research center
Siriraj Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Investigator's Global Assessment score (IGA) after treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Change of total sign score (TSS) after treatment | 2, 4 and 8 weeks | The Total sign score (TSS) 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 TSS score was the sum of 5-point rating scores for erythema, induration and scaling (0 = no sign, 1 = slight signs, 2 = moderate signs, 3 = severe signs and 4 = very severe signs) |
| Number of patients with clear or absent disease after treatment | 8 weeks | Number of patients with clear or absent disease were recorded after treated 8 weeks with 0.25% Desoximetasone cream (Topoxy®), 0.25% Desoximetasone cream (Topicorte®) or placebo. |
| Side effects after treatment | 2, 4 and 8 weeks | Cutaneous side effects (e.g. skin discomfort, skin atrophy, telangiectasia) from 0.25% Desoximetasone cream were recorded after treated 2, 4 and 8 weeks. The side effects were scored as 0 = none, 1 = mild, 2 = moderate, 3 = severe for skin discomfort, skin atrophy and telangiectasia. |
Countries
Thailand
Contacts
Primary ContactPichanee Chaweekulrat, M.D.
Outcome results
None listed