CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 22 enrolled
Drug / intervention
Doxycycline Anhydrous 40 MG +1 moredrug
Likely dose
Doxycycline Anhydrous 40 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT03457636
NCT03457636Phase 4Completed

The Use of Oracea and Epiduo Forte in Severe Acne Patients

Derm Research, PLLC·interventional·Posted Mar 7, 2018·Updated Apr 3, 2019

In Brief

A Phase 4 clinical trial evaluating Doxycycline Anhydrous 40 MG and Adapalene/Benzoyl Peroxide Gel 0.3-2.5% for Acne. Completed, enrolled 22 participants across 1 site.

Detailed Summary

This is a single-center, open label pilot study. The study is comprised of 5 study visits; Screening, Baseline, and weeks 4, 8, and 12. All subjects will receive Oracea once daily (QD) and Epiduo Forte at Baseline. We will evaluate Investigator Global Assessment (IGA), total lesion count, inflammatory lesion count, non-inflammatory lesion count, adverse events and concomitant medications.

Study Details

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

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedMar 7, 2018
Enrollment StartMar 19, 2018
Primary CompletionNov 1, 2018
Study CompletionJan 4, 2019
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 8.3 years ago

Interventions

Doxycycline Anhydrous 40 MGdrug

One Oracea Capsule (40 mg) should be taken once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals

Adapalene/Benzoyl Peroxide Gel 0.3-2.5%drug

Epiduo Forte should be applied in a thin layer to affected areas of the face and/or trunk once daily after washing, with care taken to avoid the eyes, lips, and mucous membranes