Trial intelligence / Profile preview

Sarecycline in facial acne vulgaris

NCT01628549Phase 2

Key facts

Status: Completed
Start: Jun 2012
Primary completion: Nov 2012
Countries: 1
Sponsor: Almirall
Modality: Small Molecules

Drugs: sarecycline
Conditions: acne vulgaris

Overview

Phase 2, randomised, double-blind trial of sarecycline in acne vulgaris (4 arms), sponsored by Almirall. Primary endpoints: Absolute Change From Baseline in the Inflammatory Lesion Count at 12 weeks and Dichotomized Investigator Global Assessment Score at 12 weeks. Started Jun 2012; status: completed.

Design

4 arms

Study design: RandomizedDouble-blind

0.75 mg/kg
Sarecycline 50 mg daily
1.5 mg/kg
Sarecycline 100 mg daily
3.0 mg/kg
Sarecycline 200 mg daily
Placebo
Placebo daily

Who it enrols

Patients 12-45 years old with moderate to severe facial acne vulgaris (IGA score 3-4), 20-50 inflammatory lesions, 30-100 noninflammatory lesions, no more than 2 nodules, and body weight between 52 and 88 kg.

Endpoints

Primary

Absolute Change From Baseline in the Inflammatory Lesion Count12 weeks
Dichotomized Investigator Global Assessment Score12 weeks

Secondary

Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 1212 weeks
Absolute Change From Baseline in the Noninflammatory Lesion Count12 weeks
Percent Change From Baseline in the Inflammatory Lesion Count12 weeks
Percent Change From Baseline in the Noninflammatory Lesion Count12 weeks
Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 1212 weeks

Results

Primary endpoints met

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