Phase 3 Completed N=378 Randomized Double-blind Treatment

Comparison of Epiduo Associated With Lymecycline Versus Epiduo Vehicle Associated With Lymecycline in Acne Vulgaris

Acne vulgaris

Source: ClinicalTrials.gov NCT01014689 ↗

Enrolled (actual)

378

Serious AEs

0.0%

Results posted

Apr 2012

Primary outcomePrimary: Percent Change From Baseline in Total Lesion Count — -74.1; -56.8 percent of change

Summary

Randomized, controlled, multi-center, double-blind, parallel-group comparison study in Subjects with moderate to severe acne vulgaris on the face. The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (BPO) 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules, in the treatment of moderate to severe acne vulgaris. The safety of the two treatment regimens will also be evaluated.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in Total Lesion Count	-74.1; -56.8	—
SECONDARY Success Rate on the Investigator's Global Assessment (IGA) at Week 12	47.6; 33.7	—

Eligibility Criteria

Inclusion Criteria

Male or female Subjects of any race, aged 12 to 35 years inclusive,
Subjects with moderate to severe facial acne vulgaris (Investigator's Global Assessment score of 3 or 4),

Exclusion Criteria

Subjects with more than 3 nodules or cysts on the face
Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.),
Subjects with a wash-out period for topical treatment on the face less than: Corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatments (2 weeks), Zinc containing drugs (1 week), Phototherapy devices for acne and cosmetic procedures (1 week)
Subjects with a wash-out period for systemic treatment less than:Acne therapy containing zinc (4 weeks), Corticosteroids, antibiotics (4 weeks), Other acne treatments (6 months), Ciproterone acetate / Chlormadinone acetate (6 months), Spironolactone / Drospirenone (3 months)
Subjects with impaired hepatic (ALT/AST > 3xULN and bilirubin > 1.5xULN) or renal (creatinine clearance greater than 60 ml/min) functions based on a blood sample,
Subjects with known intolerance to lactose,

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Data sourced from ClinicalTrials.gov (NCT01014689). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.