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-GarcÃa 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
Abstract
BACKGROUND: Minocycline and lymecycline are used in the treatment of acne, but there is not enough evidence to support superior efficacy of one of them.
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.
INTRODUCTION
Currently systemic antibiotics are indicated in the treatment of mild-to-moderate
papulopustular acne, severe papulopustular /moderate nodular acne, and severe nodular /conglobate acne in combination
with retinoids and/or topical benzoyl peroxide.1
Minocycline and lymecycline have been compared in different studies for acne treatment.
In a multicentre, randomized, double-blind and double-dummy study, minocycline and lymecycline were
compared in the treatment of moderately severe acne vulgaris. 73 patients received oral minocycline,
100 mg/day for 2 weeks then 100 mg every other day for 10 weeks and 71 lymecycline, 300 mg/day for 2
weeks, then 150 mg/day for 10 weeks. Inflammatory lesions were reduced by 52.2% and 50.6% with
minocycline and lymecycline, respectively, and non-inflammatory lesions by 32.2% and 40.6%.
Both treatments were similarly well tolerated. Nineteen patients (26%) in the minocycline
group experienced 27 adverse events, the most frequent were gastrointestinal disorders (n=7)
and dermatological events (n=4); in the lymecycline group 15 (21.1%) patients
had 17 adverse events with four gastrointestinal disorders and two dermatological events.2
A randomized, double-blind study compared the effect of three treatments
in patients with moderate to severe acne. Thirty one patients had minocycline
100 mg daily for 4 weeks followed by 50 mg daily for 8 weeks, 28 minocycline 50 mg
daily for 12 weeks and 27 lymecycline 300 mg daily for 12 weeks. By the end of the
treatment, authors reported that minocycline 100/50 mg patients had significantly
less total lesions (P< 0.05) than patients in the lymecycline 300 mg group.
This group reported also significantly less papules than the other two groups.
Dual-Flow Cytometry Analysis was used to determine the number
