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
试验速览
- 阶段
- 3 期
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Change of Investigator's Global Assessment score (IGA) after treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.)
干预措施: 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.)
干预措施: 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.)
干预措施: 0.25% Desoximetasone cream (Topicorte®) (Drug)
结局指标
主要结局
Change of Investigator's Global Assessment score (IGA) after treatment
时间窗: 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)
次要结局
- 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)
研究者
Pichanee Chaweekulrat
M.D.
Siriraj Hospital