Overview

This trial is active, not recruiting.

Condition acne
Treatments triamcinolone, tretinoin, emollient
Sponsor Carilion Clinic
Start date June 2015
End date January 2016
Trial size 20 participants
Trial identifier NCT02704507, 1771

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
triamcinolone
topical application nightly to half the face for 4 weeks
tretinoin
topical application nightly for 8 weeks
(Placebo Comparator)
Topical retinoid plus topical emollient applied daily to the opposite half of the face for 4 weeks, followed by 4 weeks of topical tretinoin.
tretinoin
topical application nightly for 8 weeks
emollient
topical application nightly to half the face for 4 weeks

Primary Outcomes

Measure
Change in subject-assessed itching and burning/stinging assessed by a 0-3 score over 8 weeks
time frame: baseline, weeks 1,2, 4, and 8
Change in physician-assessed erythema scores assessed by a 0-4 scale over 8 weeks.
time frame: baseline, weeks 1,2, 4, and 8
Change in physician-assessed dryness scores assessed by a 0-4 scale over 8 weeks.
time frame: baseline, weeks 1,2, 4, and 8
Change in physician-assessed peeling scores assessed by a 0-4 scale over 8 weeks.
time frame: baseline, weeks 1,2, 4, and 8

Secondary Outcomes

Measure
Change in physician-assessed inflammatory and non-inflammatory lesion counts over 8 weeks
time frame: baseline, weeks 1,2, 4, and 8
Change in physician-assessed global acne scores over 8 weeks.
time frame: baseline, weeks 1,2, 4, and 8

Eligibility Criteria

Male or female participants at least 12 years old.

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

Additional Information

Official title Addition of a Topical Steroid to a Topical Retinoid: a Randomized, Split-face, Placebo-controlled, Double-blind, Single-center Clinical Study
Principal investigator Michael Kolodney, MD, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Carilion Clinic.