Clinical trial NCT03457636: The Use of Oracea and Epiduo Forte in Severe Acne Patients
Official title: The Use of Oracea and Epiduo Forte in Severe Acne Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne
Lead sponsor: Derm Research, PLLC
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 22
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 -

Primary outcomes:
measure: Investigator Global Assessment (IGA) Score
timeFrame: Baseline, Week 4, Week 8, Week 12
Secondary outcomes:
measure: IGA Score
timeFrame: 12 weeks
measure: Inflammatory Lesion Count
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Non-inflammatory Lesion Count
timeFrame: Baseline, Week 4, Week 8, Week 12
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Skin Sciences, PLLC
state: Kentucky
Study officials:
affiliation: Skin Sciences, PLLC
name: Leon H. Kircik, M.D.
role: PRINCIPAL_INVESTIGATOR
References: