Acne
Conditions
Keywords
tretinoin, topical steroid, irritation, retinoid induced irritation
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.
Interventions
DRUGTriamcinolone
topical application nightly to half the face for 4 weeks
DRUGTretinoin
topical application nightly for 8 weeks
DRUGEmollient
topical application nightly to half the face for 4 weeks
Sponsors
Carilion Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed