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

NCT ID: NCT02704507

Last Updated: 2016-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-06-30

Brief 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.

Detailed 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.

Conditions

Acne

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Triamcinolone

Intervention Type: DRUG

topical application nightly to half the face for 4 weeks

Tretinoin

Intervention Type: DRUG

topical application nightly for 8 weeks

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.

Group Type: PLACEBO_COMPARATOR

Tretinoin

Intervention Type: DRUG

topical application nightly for 8 weeks

Emollient

Intervention Type: DRUG

topical application nightly to half the face for 4 weeks

Interventions

Triamcinolone

topical application nightly to half the face for 4 weeks

Intervention Type: DRUG

Tretinoin

topical application nightly for 8 weeks

Intervention Type: DRUG

Emollient

topical application nightly to half the face for 4 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Carilion Clinic

OTHER

Sponsor Role: lead

Responsible Party

Michael Kolodney

Section Chief Dermatology, Carilion Clinic Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Kolodney, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Carilion Clinic

Other Identifiers

1771

Identifier Type: -

Identifier Source: org_study_id