Clinical trial NCT02704507: Addition of a Topical Steroid to a Topical Retinoid in Acne Patients
Official title: Addition of a Topical Steroid to a Topical Retinoid: a Randomized, Split-face, Placebo-controlled, Double-blind, Single-center Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acne
Keywords: tretinoin
topical steroid
irritation
retinoid induced irritation
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in subject-assessed itching and burning/stinging assessed by a 0-3 score over 8 weeks
timeFrame: baseline, weeks 1,2, 4, and 8
measure: Change in physician-assessed erythema scores assessed by a 0-4 scale over 8 weeks.
timeFrame: baseline, weeks 1,2, 4, and 8
measure: Change in physician-assessed dryness scores assessed by a 0-4 scale over 8 weeks.
timeFrame: baseline, weeks 1,2, 4, and 8
measure: Change in physician-assessed peeling scores assessed by a 0-4 scale over 8 weeks.
timeFrame: baseline, weeks 1,2, 4, and 8
Secondary outcomes:
measure: Change in physician-assessed inflammatory and non-inflammatory lesion counts over 8 weeks
timeFrame: baseline, weeks 1,2, 4, and 8
measure: Change in physician-assessed global acne scores over 8 weeks.
timeFrame: baseline, weeks 1,2, 4, and 8
Other outcomes:
Locations:
Study officials:
affiliation: Carilion Clinic
name: Michael Kolodney, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: