Tretinoin microsphere gel pump 0.04% versus tazarotene cream 0.05% in the treatment of mild-to-moderate facial acne vulgaris.
This 12-week, single-center, investigator-blinded, randomized, parallel-design study assessed the safety and efficacy of tretinoin microsphere gel 0.04% delivered by pump (TMG PUMP) to tazarotene cream 0.05% (TAZ) in mild-to-moderate facial acne vulgaris. Efficacy measurements included investigator global assessment (IGA), lesion counts, and subject self-assessment of acne signs and symptoms. Efficacy was generally comparable between treatment groups, although TMG PUMP provided more rapid results in several parameters. IGA showed a more rapid mean change from baseline at week 4 in the TMG PUMP group (-0.18 versus -0.05 in the TAZ subjects). TMG PUMP yielded more rapid improvement in papules. At week 4, the mean percentage change from baseline in open comedones was statistically significant at -64% in the TMG PUMP group (P=0.0039, within group) versus -19% in the TAZ group (not statistically significant within the group; P=0.1875). Skin dryness, peeling and pruritus were significantly less in the TMG PUMP group as early as week 4. Adverse events related to study treatment were rare in both groups and all resolved upon discontinuation of study medication.
Kircik
Leon H
LH
Mount Sinai School of Medicine, New York, NY, USA. wedoderm@bellsouth.net
D000152:Acne Vulgaris / Q000188:drug therapy* / Q000503:physiopathology; D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D002648:Child; D005260:Female; D005782:Gels; D006801:Humans; D007641:Keratolytic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008863:Microspheres; D009539:Nicotinic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010865:Pilot Projects; D012720:Severity of Illness Index; D016037:Single-Blind Method; D016896:Treatment Outcome; D014212:Tretinoin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult; D012176:Retinoids
D005782:Gels; D007641:Keratolytic Agents; D009539:Nicotinic Acids; D014212:Tretinoin; C086827:tazarotene; D012176:Retinoids