The Use of Oracea and Epiduo Forte in Severe Acne Patients

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.

• Doxycycline Anhydrous 40 MG (Drug), also known as Oracea: 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), also known as Epiduo Forte 0.3%-2.5% Topical Gel: 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

Primary outcomes

• Investigator Global Assessment (IGA) Score [Baseline, Week 4, Week 8, Week 12]: The IGA is an assessment by the Investigator to assess the severity of the subject's disease wherein 0=Clear Skin, 1=Almost Clear, 2=Mild Severity, 3=Moderate, 4=Severe, 5=Very Severe. Lower score indicate less severe disease.

Secondary outcomes

• IGA Score [12 weeks]: The percent of subjects who have at least a 2 grade improvement on IGA score
• Inflammatory Lesion Count [Baseline, Week 4, Week 8, Week 12]: Inflammatory lesions here include papules and pustules on the face from edge of hairline to mandibular line as counted by the Investigator. Lower counts indicate less severe disease.
• Non-inflammatory Lesion Count [Baseline, Week 4, Week 8, Week 12]: Non-inflammatory lesions here include open and closed comedones. These are counted on the face by the investigator from edge of hairline to mandibular line and lower count indicates less severe disease.

Sex: All, ages: 12 Years to any, accepts healthy volunteers

Inclusion Criteria:

i. Outpatient, male or female subjects of any race, and at least 12 years of age or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline (test must have a sensitivity of at least 25 milli-international units/milliliter \[mIU/ml\] for human chorionic gonadotropin) and practice a reliable method of contraception throughout the study:

A female is considered of childbearing potential unless she is:

* postmenopausal for at least 12 months prior to study drug administration;
* without a uterus and/or both ovaries; or
* has been surgically sterile for at least 6 months prior to study drug administration

Reliable methods of contraception are:

* hormonal methods or intrauterine device in use ≥90 days prior to study drug administration;
* barrier methods plus spermicide in use at least 14 days prior to study drug administration; or
* vasectomized partner (vasectomy must be performed 3 months prior to first study drug administration or in the alternative a zero sperm count will suffice) \[Exception: female subjects of childbearing potential who are not sexually active will not be required to practice a reliable method of contraception. These subjects may be enrolled at the Investigator's discretion if they are counseled to remain sexually inactive during the study and understand the possible risks in getting pregnant during the study.\] ii. Facial acne IGA score of 4 iii. Minimum of 20 or more inflammatory lesions and 20 or more non-inflammatory lesions and not more than 4 nodules iv. Able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization forms. Subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian

Exclusion Criteria:

i. Female subjects who are pregnant (positive urine pregnancy test ), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control ii. Allergy or sensitivity to any component of the test medication iii. Subjects who have not complied with the proper wash-out periods for prohibited medications (Supplement I)> iv. Medical condition that, in the opinion of the investigator, contraindicates the subject's participation in the clinical study v. Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris vi. Evidence of recent alcohol or drug abuse vii. History of poor cooperation, non-compliance with medical treatment, or unreliability viii. Exposure to an investigational drug study within 30 days of the Baseline Visit -

Participant flow

Outcome results

• Investigator Global Assessment (IGA) Score (Primary), Count of participants, Participants: Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide 0
• IGA Score (Secondary), Count of participants, Participants: Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide 19
• Inflammatory Lesion Count (Secondary), Median, count of lesions: Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide 33 +/- 7
• Non-inflammatory Lesion Count (Secondary), Median, lesion count: Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide 33 +/- 7

Adverse events

Time frame: 12 weeks

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2018-01-09)

• Leon H. Kircik, M.D., Principal investigator, Skin Sciences, PLLC