Interest of Topical Spironolactone's Administration to Prevent Corticoid-induced Epidermal Atrophy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- histological measure of epidermal thickness
研究概览
简要总结
The purpose of this study is to determine whether spironolactone could significantly reduce cutaneous atrophy due to corticosteroids.
详细描述
skin cutaneous atrophy due to corticosteroids limits the long-term use of highly potent topical glucocorticoids which are the treatment of choice for many inflammatory skin diseases. This atrophy results in fragile skin, delay of healing, purpura, irreversible striae, telangiectasia and secondary infections. Up to now, no treatments can prevent efficiently skin atrophy.
The mineralocorticoid receptor, belonging to the superfamily of nuclear receptors, is expressed in human epidermis but its actual function is unknown. Experimental results in animals obtained in INSERM unit U772 by Dr N FARMAN suggest that spironolactone which is a mineralocorticoid receptor antagonist 1- might limit epidermal atrophy and 2- might promote healing.
Study description We propose to test clinically these hypotheses for the first time on humans, at the CIC in BICHAT's hospital on healthy volunteers: 1- by applying on the skin a highly potent cutaneous corticosteroids in association or not with spironolactone, 2- by applying or not spironolactone on wounds after 3-mm punch biopsies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers of both sex, aged between 20 and 50 years
- •Woman with effective contraception and pregnancy test negative before inclusion.
- •Subject considered healthy after a detailed review (interview, clinical examination)
- •Subject belonging to a social security scheme (beneficiary or have the right)
- •Subject having signed a free and informed consent
- •Integrity of the skin at forearms
- •Subject available the next 7 weeks and able to go to CIC once a day from Monday to Friday
- •Subject accepting four skin biopsies at D29
- •no washing forearms during 2 hours after applications
排除标准
- •Chronic Alcoholism
- •Drug-addiction (comprehensive interview with a sampling in case of doubt)
- •Woman pregnant or breast-feeding
- •Subject involved in another trial or in exclusion period of another protocol
- •Subject has already received more than 3700 Euros in compensation for damages suffered constraints in the past 12 months for his involvement in biomedical researches
- •Subject has already participated in this protocol
- •Phototypes 5 and 6
- •Clinical skin atrophy
- •History of severe chronic skin disease
- •Problems of healing
- •Treatment with oral corticosteroids, mineralocorticoids or spironolactone (Aldactone, Flumach, Practon, Spiroctan, Spironone, Aldactazine, ALDALIX, Practazin, Spiroctazine ...)
研究组 & 干预措施
Clobetasol + Spironolactone
0.05% clobetasol and 5% spironolactone
干预措施: Clobetasol + Spironolactone (Drug)
Clobetasol + Placebo
0.05% clobetasol + inert excipient
干预措施: Clobetasol + Placebo (Drug)
Placebo + Spironolactone
Inert excipient + 5% spironolactone
干预措施: Placebo + Spironolactone (Drug)
Placebo + placebo
Inert excipient
干预措施: Placebo + Placebo (Drug)
结局指标
主要结局
histological measure of epidermal thickness
时间窗: day 29
biopsies will be performed in the center of the treated sites. Epidermal thickness will be measured from the basal lamina to the lower border of the stratum corneum. This will be determined by image analysis from the average of fields per skin section.
次要结局
- Dermis thickness evaluated by ultrasound(days 1, 15, 29)
- Mineral receptors and glucoreceptors expression ratio performed by immunohistochemistry(day 29)
- delay of healing after skin biopsies performed on day 29(days 32, 36, 39, 43, 46, 50)