NCT03457636

The Use of Oracea and Epiduo Forte in Severe Acne Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Derm Research, PLLC · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

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.

Detailed description

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, adverse events and concomitant medications.

Conditions

• Acne

Interventions

Type	Name	Description
DRUG	Doxycycline Anhydrous 40 MG	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
DRUG	Adapalene/Benzoyl Peroxide Gel 0.3-2.5%	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

Timeline

• Start date: 2018-03-19
• Primary completion: 2018-11-01
• Completion: 2019-01-04
• First posted: 2018-03-07
• Last updated: 2019-04-03
• Results posted: 2019-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study