Addition of a Topical Steroid to a Topical Retinoid: a Randomized, Split-face, Placebo-controlled, Double-blind, Single-center Clinical Study
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Change in physician-assessed peeling scores assessed by a 0-4 scale over 8 weeks.
研究概览
简要总结
A randomized, split-face, placebo-controlled, double-blind, single-center clinical trial comparing topical retinoid on half the face and retinoid plus topical steroid on the other half.
详细描述
A randomized, split-face, placebo-controlled, double-blind, single-center clinical trial wherein 20 patients received daily 0.05% tretinoin with one half of the face receiving triamcinolone 0.025% and the other half an inert emollient for 4 weeks. Subjects continued applying tretinoin 0.05% daily to the bilateral face without triamcinolone or emollient for an additional 4 weeks. Investigator's Global Assessment, lesion counts, and study subject's self-assessments of burning/stinging, itching, erythema, and dryness/scaling will be collected at 1, 2, 4, and 8 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fitzpatrick skin types I, II, or III
- •Will and ability to discontinue use of topical medicines on the face for study duration
- •Capability to understand and provide informed consent
排除标准
- •Use of oral retinoids within previous 6 months
- •Use of corticosteroids on the face or systemic corticosteroids within previous 4 weeks
- •Any additional facial skin condition (i.e., rosacea, seborrheic dermatitis, etc.)
- •Female participants who are pregnant, nursing, or planning pregnancy while participating in the study
- •Hypersensitivity to ingredients in study formulations
- •Existence of an underlying condition that an investigator feels would hinder a participant's ability to complete the study or appropriately follow directions
研究组 & 干预措施
Topical steroid
Topical retinoid plus topical steroid applied daily to half of the face for 4 weeks, followed by 4 weeks of topical tretinoin. Patients will be randomized to which side receives the topical steroid.
干预措施: Triamcinolone (Drug)
Topical steroid
Topical retinoid plus topical steroid applied daily to half of the face for 4 weeks, followed by 4 weeks of topical tretinoin. Patients will be randomized to which side receives the topical steroid.
干预措施: Tretinoin (Drug)
Topical emollient
Topical retinoid plus topical emollient applied daily to the opposite half of the face for 4 weeks, followed by 4 weeks of topical tretinoin.
干预措施: Tretinoin (Drug)
Topical emollient
Topical retinoid plus topical emollient applied daily to the opposite half of the face for 4 weeks, followed by 4 weeks of topical tretinoin.
干预措施: Emollient (Drug)
结局指标
主要结局
Change in physician-assessed peeling scores assessed by a 0-4 scale over 8 weeks.
时间窗: baseline, weeks 1,2, 4, and 8
Physicians will assess each side of subjects' face for peeling: (0) absent: no peeling; (1) slight:mild localized peeling; (2) mild: mild and diffuse peeling; (3) moderate: moderate and diffuse peeling; (4) severe:moderate to prominent, dense peeling.
Change in subject-assessed itching and burning/stinging assessed by a 0-3 score over 8 weeks
时间窗: baseline, weeks 1,2, 4, and 8
Subject will given a questionnaire to assess itching and burning/stinging on each side of the face on a 0-3 scale: (0) None- Normal, no discomfort; (1) Slight- A noticeable discomfort that causes intermittent awareness; (2) Moderate- A noticeable discomfort that causes intermittent awareness and interferes occasionally with normal daily activities; (3) Strong- A definite continuous discomfort that interferes with normal daily activities.
Change in physician-assessed erythema scores assessed by a 0-4 scale over 8 weeks.
时间窗: baseline, weeks 1,2, 4, and 8
Physicians will assess each side of subjects' face for erythema: (0) absent: no redness; (1) slight: Faint red or pink coloration, barely perceptible; (2) mild: light red or pink coloration; (3) moderate: medium red coloration; (4) severe: beet red coloration.
Change in physician-assessed dryness scores assessed by a 0-4 scale over 8 weeks.
时间窗: baseline, weeks 1,2, 4, and 8
Physicians will assess each side of subjects' face for dryness: (0) absent: none; (1) slight: barely perceptible dryness with no flakes or fissure formation; (2) mild: easily perceptible dryness with no flakes or fissure formation; (3) moderate: easily noted dryness and flakes but no fissure formation; (4) severe:easily noted dryness with flakes and fissure formation.
次要结局
- Change in physician-assessed global acne scores over 8 weeks.(baseline, weeks 1,2, 4, and 8)
- Change in physician-assessed inflammatory and non-inflammatory lesion counts over 8 weeks(baseline, weeks 1,2, 4, and 8)
研究者
Michael Kolodney
Section Chief Dermatology, Carilion Clinic Dermatology
Carilion Clinic