Investigation of the Topical Retinoid, Atralin Gel 0.05% for the Treatment of Erythematotelangiectatic Rosacea
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging
研究概览
简要总结
Erythematotelangiectatic rosacea is a type of rosacea that causes a red face often with frequent flushing, topical sensitivity and prominent blood vessels. We think that long term damage to skin from the sun (photodamage) may play a role in causing this type of rosacea. Tretinoin is a topical medication that is known to improve photodamage. We want to find out if Atralin (tretinoin 0.05%) Gel used for up to 46 weeks will improve erythematotelangiectatic rosacea (ETR).
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, Care Provider, Investigator)
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
- •Subjects 18 years of age and older of any race.
- •Clinical diagnosis of mild to moderate erythematotelangiectatic facial rosacea based on physician evaluation.
- •Willing and able to understand and sign informed consent.
- •Able to complete study and comply with study procedures.
排除标准
- •Severe self reported facial sensitivity
- •History of allergy to fish
- •Severe sun sensitivity
- •Severe erythematotelangiectatic rosacea requiring systemic treatment
- •Papulopustular, Ocular-only, Phymatous rosacea, Steroid rosacea, pyoderma faciale
- •Unwilling to undergo facial biopsies
- •Concomitant use of medications that are reported to exacerbate rosacea, such as topical and systemic steroids
- •Use of topical rosacea treatments in the past 2 weeks.
- •Use of systemic antibiotics in the past 4 weeks.
- •Use of systemic retinoids within the past 6 months.
- •Use of topical retinoids within the past 3 months
- •Use of laser or light based rosacea treatments within the past 2 months.
- •Cosmetic procedures (e.g., superficial chemical peels, exfoliation or microdermabrasion of the face) within the past two months
- •Use of topical anti-aging medications including alpha hydroxy acids, salicylic acid, beta-hydroxy acid, vitamin A, vitamin E, ascorbic acid
- •Other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments.
- •Clinically significant abnormal findings or conditions (other than rosacea), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
- •If female, Subjects who are either of non-child bearing potential (defined as postmenopausal -absence of menstrual bleeding for 1 year - or as having undergone bilateral tubal ligation, hysterectomy or bilateral ovariectomy) or, if of childbearing potential, Subjects who have had a negative urine pregnancy test at the beginning of the study, and have agreed to practice appropriate birth-control to prevent pregnancy during the study.(The type and dose of birth control must have been stable for at least 2 months prior to study entry and not be expected to change during the study).
- •Subjects who are lactating.
- •Use of any investigational therapy within the past 4 weeks.
- •Known hypersensitivity or previous allergic reaction to retinoids
- •Carcinoid, Pheochromocytoma or other systemic flushing causes
研究组 & 干预措施
Vehicle gel
Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
干预措施: vehicle gel (Drug)
Atralin gel
Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
干预措施: Atralin gel (Drug)
结局指标
主要结局
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging
时间窗: 24 weeks
Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the Facial Stinging feature of their rosacea.
Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia
时间窗: 24 weeks
Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product
时间窗: 24 weeks
Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to give an overall self-assessment of product tolerance.
Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin
时间窗: 24 weeks
Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin
Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema)
时间窗: 24 weeks
Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin
Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema
时间窗: 24 weeks
Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing
时间窗: 24 weeks
Flushing is defined as a temporary redness of the face, neck and chest. Subjects were asked to choose the best answer that applied to them in response to the questions "Do you have flushing?".
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning
时间窗: 24 weeks
Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the facial burning feature of their rosacea.
次要结局
- Molecular Markers of Inflammation(24 weeks)
- Severity of Erythematotelangiectatic Signs: Facial Edema(2, 6, 12, 18 weeks)
- Severity of Erythematotelangiectatic Signs: Dryness/Irritation(2, 6, 12, 18 weeks)
- Skin Irritation Assessed by Facial Stinging Upon Product Application(2, 6, 12, 18 weeks)
- Skin Irritation Assessed by Facial Burning Upon Product Application(2, 6, 12, 18 weeks)
- Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging(2, 6, 12, 18 weeks)
- Skin Irritation Assessed by Facial Itching Upon Product Application(2, 6, 12, 18 weeks)
- Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea(2, 6, 12, 18 and 24 weeks)
- Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment(2, 6, 12, 18 weeks)
- Photodamage(24 weeks)
- Signs of Other Rosacea Subtypes: Papulopustular(2, 6, 12, 18, 24 weeks)
- Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness)(2, 6, 12, 18 weeks)
- Severity of Erythematotelangiectatic Signs: Telangiectasia(2, 6, 12, 18 weeks)
- Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing(2, 6, 12, 18 weeks)
- Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning(2, 6, 12, 18 weeks)
- Quality of Life(2, 6, 12, 18, 24 weeks)
- Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea(2, 6, 12, 18 and 24 weeks)
- Molecular Evidence of Photodamage(24 weeks)
研究者
Lisa E. Maier
Assistant Professor
University of Michigan