Status:
COMPLETED
The Use of Oracea and Epiduo Forte in Severe Acne Patients
Lead Sponsor:
Derm Research, PLLC
Conditions:
Acne
Eligibility:
All Genders
12+ years
Phase:
PHASE4
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 Fort...
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...
Eligibility Criteria
Inclusion
- 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
- 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 -
Key Trial Info
Start Date :
March 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2019
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03457636
Start Date
March 19 2018
End Date
January 4 2019
Last Update
April 3 2019
Active Locations (1)
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1
Skin Sciences, PLLC
Louisville, Kentucky, United States, 40014