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

Sponsor

Carilion Clinic (Other)

Overall Status

Unknown status

CT.gov ID

NCT02704507

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne	Drug: Triamcinolone Drug: Tretinoin Drug: Emollient	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Jan 1, 2016

Anticipated Study Completion Date :

Jun 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in subject-assessed itching and burning/stinging assessed by a 0-3 score over 8 weeks [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.
Change in physician-assessed erythema scores assessed by a 0-4 scale over 8 weeks. [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.
Change in physician-assessed dryness scores assessed by a 0-4 scale over 8 weeks. [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.
Change in physician-assessed peeling scores assessed by a 0-4 scale over 8 weeks. [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.

Secondary Outcome Measures

Change in physician-assessed inflammatory and non-inflammatory lesion counts over 8 weeks [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.
Change in physician-assessed global acne scores over 8 weeks. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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