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

March 5, 2016 updated by: Michael Kolodney, Carilion Clinic

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Triamcinolone
topical application nightly to half the face for 4 weeks
Drug: Tretinoin
topical application nightly for 8 weeks
Placebo Comparator: 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.
Drug: Tretinoin
topical application nightly for 8 weeks
Drug: Emollient
topical application nightly to half the face for 4 weeks

What is the study measuring?

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
Time Frame: baseline, weeks 1,2, 4, and 8
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.
Time Frame: baseline, weeks 1,2, 4, and 8
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.
Time Frame: baseline, weeks 1,2, 4, and 8
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.
Time Frame: baseline, weeks 1,2, 4, and 8
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
Time Frame: baseline, weeks 1,2, 4, and 8
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.
Time Frame: baseline, weeks 1,2, 4, and 8
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carilion Clinic

Investigators

  • Principal Investigator: Michael Kolodney, MD, PhD, Carilion Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

February 13, 2016

First Submitted That Met QC Criteria

March 5, 2016

First Posted (Estimate)

March 10, 2016

Study Record Updates

Last Update Posted (Estimate)

March 10, 2016

Last Update Submitted That Met QC Criteria

March 5, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1771

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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