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

Carilion Clinic

Status: Unknown

Conditions: Acne

Treatments: Drug: Tretinoin; Drug: Triamcinolone; Drug: Emollient

Study type: Interventional

Funder types: Other

Identifiers

NCT02704507

1771

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Topical steroid

Experimental group

Description:

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.

Treatment:

Drug: Tretinoin

Drug: Triamcinolone

Topical emollient

Placebo Comparator group

Description:

Topical retinoid plus topical emollient applied daily to the opposite half of the face for 4 weeks, followed by 4 weeks of topical tretinoin.

Treatment:

Drug: Emollient

Drug: Tretinoin