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

NCT02704507 | Unknown

• 1 other identifier: 1771
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acne

Keywords

tretinoin; topical steroid; irritation; retinoid induced irritation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Change in physician-assessed inflammatory and non-inflammatory lesion counts over 8 weeks

  baseline, weeks 1,2, 4, and 8

• Change in physician-assessed global acne scores over 8 weeks.

  baseline, weeks 1,2, 4, and 8

Study Arms (2)

Topical steroid

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.

Drug: Triamcinolone; Drug: Tretinoin

Topical emollient

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.

Drug: Tretinoin; Drug: Emollient

Interventions

Triamcinolone DRUG

topical application nightly to half the face for 4 weeks

Topical steroid

Tretinoin DRUG

topical application nightly for 8 weeks

Topical emollient; Topical steroid

Emollient DRUG

topical application nightly to half the face for 4 weeks

Topical emollient

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carilion Clinic: lead

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Triamcinolone; Tretinoin; Emollients

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors; Dermatologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Michael Kolodney, MD, PhD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Chief Dermatology, Carilion Clinic Dermatology

Study Record Dates

• First Submitted: February 13, 2016
• First Posted: March 10, 2016
• Study Start: June 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 10, 2016

Record last verified: 2016-03