Addition of a Topical Steroid to a Topical Retinoid in Acne Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Addition of a Topical Steroid to a Topical Retinoid: a Randomized, Split-face, Placebo-controlled, Double-blind, Single-center Clinical Study

Conditions
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Acne

Intervention / Treatment
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* Drug: Triamcinolone
* Drug: Tretinoin
* Drug: Emollient


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical steroid<br>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. | Drug: Triamcinolone<br>* topical application nightly to half the face for 4 weeks<br>Drug: Tretinoin<br>* topical application nightly for 8 weeks<br>|
| Placebo Comparator: Topical emollient<br>Topical retinoid plus topical emollient applied daily to the opposite half of the face for 4 weeks, followed by 4 weeks of topical tretinoin. | Drug: Tretinoin<br>* topical application nightly for 8 weeks<br>Drug: Emollient<br>* topical application nightly to half the face for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in subject-assessed itching and burning/stinging assessed by a 0-3 score over 8 weeks | 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. | baseline, weeks 1,2, 4, and 8 | 
| Change in physician-assessed erythema scores assessed by a 0-4 scale over 8 weeks. | 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. | baseline, weeks 1,2, 4, and 8 | 
| Change in physician-assessed dryness scores assessed by a 0-4 scale over 8 weeks. | 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. | baseline, weeks 1,2, 4, and 8 | 
| Change in physician-assessed peeling scores assessed by a 0-4 scale over 8 weeks. | 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. | baseline, weeks 1,2, 4, and 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physician-assessed inflammatory and non-inflammatory lesion counts over 8 weeks | Physicians will count the inflammatory and non-inflammatory lesions on each side of the face over 8 weeks. | baseline, weeks 1,2, 4, and 8 | 
| Change in physician-assessed global acne scores over 8 weeks. | Physicians will grade each side of the subject's face on the Global Acne Score 0-5 over 8 weeks. | baseline, weeks 1,2, 4, and 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tretinoin, topical steroid, irritation, retinoid induced irritation