An Investigator-Blind, Phase 4 Study Assessing the Facial Irritation Potential of Two Acne Treatment Products Using a Split-Face Model
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Assessment of Facial Irritation and Cutaneous Effects
研究概览
简要总结
A study to compare the skin irritation potential of two marketed gels for acne treatment, each applied to half of the face of healthy volunteers.
详细描述
At the Baseline Visit, following satisfaction of entry criteria and screening procedures, all subjects will be applying two products on their faces, each on half face. The side of face receiving each product is randomly assigned. One group will use tretinoin facial gel on the left side and adapalene facial gel on the right side of the face daily for two consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for two consecutive weeks after washing with the same study-supplied facial wash.
Subjects will return to the study center every weekday morning for evaluation and for the morning application of both study products. Study personnel will monitor application on the weekdays. There will be a daily clinical evaluation of skin irritation by a blinded dermatologist and by subjects. At baseline and at the end of each week subjects will be photographed and have chromometer readings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Before screening, subjects (or legally authorized representative) must read and sign the IRB approved Informed Consent Form (includes HIPPA and Photo release).
- •Subject must have Fitzpatrick Skin Type I, II or III, and judged by the Investigator to have healthy skin.
- •Subject's bilateral facial skin must be clear of any confounding irritation, rashes, acne, rosacea, etc. prior to study start.
- •Subject must be free of systemic retinoids for at least 2 months.
- •Subject must not be using any topical retinoids, systemic antibiotics, nicotinamide or systemic steroids for 1 month prior to study start.
- •All other topical medications to face (e.g., steroids, antimicrobials, salicylic acid, and benzoyl peroxide) and cosmetics containing retinols, AHA's and bleaching agents such as hydroquinone are to be discontinued at least 2 weeks prior to study initiation.
- •Subjects will not apply any emollients and cosmetics to the facial area 24 hours prior to study initiation.
- •Subject must not be planning to become pregnant or nursing before entering the study and during the study period. In addition if using birth control pills, subject must be stabilized for at least 2 months. If subject is of child bearing potential, subject must be using approved method of birth control. Approved methods are birth control pills, implants, patches or spermicide with condoms.
排除标准
- •Subjects who are pregnant or nursing.
- •Subjects who have a grade 1 or more for facial erythema.
- •Subjects who exhibit any skin condition (i.e., atopic dermatitis, seborrheic dermatitis, and psoriasis) or disease that may require concurrent therapy or may confound the evaluation of drug safety or efficacy.
- •Subjects who have a history of hypersensitivity to any of the formulation components listed in Appendix
- •Subjects who have received any experimental drug or used any experimental device 30 days prior to initiation of study therapy.
- •Subjects who have excessive facial hair that may obstruct or hinder the evaluation of any reactions.
- •Subjects who use any known photosensitizing agents.
- •Subjects who presently have skin cancer or actinic keratosis on the face.
研究组 & 干预措施
Tretinoin and Adapalene gels
Adapalene facial gel and tretinoin facial gel applied daily for two weeks on opposite sides of the face (in a split-face model)
干预措施: Adapalene Gel (Drug)
Tretinoin and Adapalene gels
Adapalene facial gel and tretinoin facial gel applied daily for two weeks on opposite sides of the face (in a split-face model)
干预措施: Tretinoin Gel (Drug)
结局指标
主要结局
Assessment of Facial Irritation and Cutaneous Effects
时间窗: cumulative daily weekday scores for two weeks
Cumulative daily weekday scores for two weeks on Expert Grader Assessments: Dryness (0-8, none-deep)and Erythema (0-8, none-severe) and Self-Assessments: Burning/Stinging (0-3, none-severe) and Itching (0-3, none-severe)
次要结局
未报告次要终点