Conditions: Acne
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 22
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: All subjects will receive at Baseline doxycycline anhydrous 40 mg (Oracea) to be taken once daily and Adapalene-Benzoyl Peroxide Gel .3-2.5% (Epiduo) to be applied once daily for 12 weeks

Interventions: intervention 1: Doxycycline Anhydrous 40 MG intervention 2: Adapalene/Benzoyl Peroxide Gel 0.3-2.5%
Intervention descriptions: intervention 1: 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 intervention 2: 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

Protocol document:
Prot_SAP_000.pdf: