NCT02899000

A Treatment for Severe Inflammatory Acne Subjects

Efficacy and Safety of Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel Plus Doxycycline in Severe Inflammatory Acne (Non-Nodulocystic) Subjects

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Demonstrate that a daily treatment regimen of adapalene 0.3%/benzoyl peroxide 2.5% gel + oral Doxycycline 200 mg is effective and safe in severe inflammatory acne with 3 or fewer nodules or cysts (non-nodulocystic) during a 12-week treatment period.

Detailed description

This Phase 4, 12-week, single-arm, open-label, multi-center investigational efficacy and safety study was conducted in subjects with severe inflammatory acne. Subjects who met the inclusion criteria and none of the exclusion criteria at the Screening visit returned to the clinic for baseline measures (Week 0) and to start treatment, which continued for up to 12 weeks. Treatment consisted of 2 investigational study drugs: * A/BPO 0.3%/2.5% gel applied to dry skin as directed by study staff once daily for 12 weeks, at night after washing. * Doxycycline hyclate 200 mg: each subject was to take 2 50-mg tablets of doxycycline hyclate in the morning and 2 at night, for a total of 4 tablets (a total of 200 mg) daily for 12 weeks.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel	Topical acne therapy
DRUG	Oral doxycycline hyclate	Tetracycline-class oral antibacterial 200 mg daily (2 tablets \[50 mg\], twice daily)

Timeline

• Start date: 2016-07-29
• Primary completion: 2017-03-28
• Completion: 2017-06-27
• First posted: 2016-09-13
• Last updated: 2022-12-09
• Results posted: 2022-12-09

Locations

1 site across 1 country: United States