CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 186 enrolled
Drug / intervention
Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel +1 moredrug
Likely dose
Adapalene 0.3%/benzoyl peroxide 2.5% gel applied topically once daily plus doxycycline hyclate 200 mg orally daily (100 mg twice daily)AI-extracted
Key inclusion· 3
  • ✓Age 12 years or older at screening
  • ✓Clinical diagnosis of severe inflammatory acne with IGA score of 4
  • ✓No more than 4 nodules or cysts >1 cm in diameter on the face
Key exclusion· 5
  • ✕Nodulocystic, conglobate acne, acne fulminans, or secondary acne (chloracne, drug-induced)
  • ✕5 or more acne nodules or cysts >1 cm in diameter on the face at screening or baseline
  • ✕Pregnant, nursing, or planning pregnancy during the study
  • ✕Any systemic acne therapy (including antibiotics) within 30 days prior to baseline

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02899000
NCT02899000Phase 4Completed
CompareCT.gov

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

Galderma R&D·interventional·Posted Sep 13, 2016·Updated Dec 9, 2022

In Brief

A Phase 4 clinical trial evaluating Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel and Oral doxycycline hyclate for Acne Vulgaris. Completed, enrolled 186 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 13, 2016
Enrollment StartJul 29, 2016
Primary CompletionMar 28, 2017
Study CompletionJun 27, 2017
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.8 years ago

Interventions

Adapalene 0.3% / benzoyl peroxide 2.5% emulsion geldrug

Topical acne therapy

Oral doxycycline hyclatedrug

Tetracycline-class oral antibacterial 200 mg daily (2 tablets \[50 mg\], twice daily)