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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone | Drug | topical application nightly to half the face for 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in physician-assessed inflammatory and non-inflammatory lesion counts over 8 weeks | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Kolodney, MD, PhD | Carilion Clinic | Principal Investigator |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D014212 | Tretinoin |
| D004643 | Emollients |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Tretinoin |
| Drug |
topical application nightly for 8 weeks |
|
| Emollient | Drug | topical application nightly to half the face for 4 weeks |
|
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 |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D014801 | Vitamin A |
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D003879 | Dermatologic Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |