Safety and Efficacy Comparison of Minocycline Microgranules vs Lymecycline in the Treatment of Mild to Moderate Acne: Randomized, Evaluator-blinded, Parallel, and Prospective Clinical Trial for 8 Weeks
June 2014 | Volume 13 | Issue 6 | Original Article | 671 | Copyright © June 2014
Jorge Ocampo-Candiani MD,a Luis Leobardo Velázquez-Arenas MD,a Alberto de la Fuente-García MD,a
Carlos Treviño-Gómezharper MD,b and Arturo Berber MD PhDc
aDermatology Departament, Facultad de Medicina y Hospital Universitario, Universidad Autónoma de Nuevo León,
Monterrey, Nuevo León, México
bFormely Medical Department, GlaxoSmithKline Mexico, Mexico DF, Mexico
cMedical Department, GlaxoSmithKline Mexico, Mexico DF, Mexico
METHODS: 170 participants from 14 to 34 years old with mild to moderate facial acne vulgaris were recruited. 84 had 100 mg of minocycline in a single daily dose for 8 weeks and 86 had 300 mg of lymecycline in a single daily dose for 8 weeks. Participants were evaluated at baseline, week 4 and week 8.
RESULTS: 65 minocycline and 60 lymecycline patients were evaluable. The last observation carried forward for the count of non-inflammatory lesions changed from 37.5 ± 17.8 to 37.7 ± 17.8 in the minocycline group and from 36.9 ± 15.5 to 33.4 ± 19.3 in the lymecycline group (no significant changes); corresponding changes in inflammatory lesions were from 19.4 ± 12.4 to 12.2 ± 10.0 in the minocycline group and from 20.1 ± 11.3 to 12.6 ± 8.4 in lymecycline group (P< 0.05 comparing baseline vs. final in both groups). Porphyrin counts varied from 899.5 ± 613.9 to 233.5 ± 219.5 in the minocycline group and from 956.9 ± 661.8 to 411.8 ± 411.5 in the lymecycline group (P<0.05 between the groups at study end). 36 (42.9%) patients receiving minocycline suffered 55 adverse events (22 of them gastrointestinal), while 28 (33.3%) lymecycline patients had 37 adverse events (15 of them gastrointestinal). One patient in the lymecycline group withdrew the study due to gastritis, and one more patient in the same group experienced eosinophilia.
CONCLUSIONS: There were no differences between the groups in non-inflammatory and inflammatory lesion counts, and in the safety profile. Treatment with minocycline induced statistically significant decrease in facial porphyrin counts compared to the group treated with lymecycline (ClinicalTrials.gov number, NCT00988026).
J Drugs Dermatol. 2014;13(6):671-676.