Finasteride Treatment of Severe Nodulocystic Acne

Completed · Phase 2 · Has a placebo group

Conditions studied: NODULOCYSTIC ACNE

In brief

Double-blind, randomized, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of once weekly, high dose oral finasteride compared to placebo for the treatment of severe nodulocystic acne in male subjects.

Key facts

Study ID

NCT02502669

Run by

Elorac, Inc.

People needed

106

Starts

2015-07-01

Expected to finish

2017-06-06

Last updated by the study team

2019-02-15

Who can join

Age: 18 and older, up to 35. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the screening procedures.
• Males 18 years to 35 years of age.
• Except for severe nodulocystic acne, subject is in generally good health.
• Ten (10) or more nodular lesions (facial and/or truncal).
• Weight between 40 and 110 kg.
• No significant disease or clinically significant finding in a physical examination.
• No clinically significant abnormal laboratory value.
• No clinically significant abnormal vital sign measurement.
• Subject is able to swallow pills.
• Subject agrees to use a medically acceptable form of barrier-method contraception (e.g. condoms with spermicide or abstinence).
• Subject is willing and able to cooperate to the extent required by the protocol.

You may not qualify if…

• Female subjects will be excluded from the study.
• Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), pyoderma faciale, sinus tracks.
• Subject with a wash out period from Baseline for topical treatment on the skin less than: Corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatment (2 weeks); Cosmetic procedures (1 week); Photodynamic therapy and laser therapy for acne (3 months).
• Subject with a washout period from Baseline for systemic treatment less than: Corticosteroids, antibiotics (4 weeks), spironolactone (3 months), other systemic acne treatments (6 months), cyproterone acetate (6 months), lithium, anticonvulsants, barbiturates, androgenic and anabolic steroids, testosterone, estrogen, anti-tuberculous drugs, cyclosporine, and azathioprine (6 months), surgical treatment of acne (12 months), finasteride or other 5α-reductase inhibitors (12 months). (Table 2)
• Subjects with current or history of prostatic disease including benign prostatic hypertrophy, or surgery on prostate.
• Known history or presence of any clinically significant unstable medical condition(s) which in the opinion of the investigator could pose a risk for the safety of the subject, e.g. diabetes, cardiovascular, liver or kidney disease.
• Subjects with any skin disease or other condition that might interfere with the evaluation of nodular acne.
• Known history or suspected carcinoma.
• Allergy to finasteride or any other ingredients in the study medications.
• Subjects with history in past 12 months of active addiction, abuse, misuse and/or dependence on drugs or alcohol.
• Use of investigational drug within 90 days prior to Day 1

Where it is running

• Omni Dermatology, Inc. — Phoenix, Arizona, United States
• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
• Dr. Ronald Moy — Beverly Hills, California, United States
• Axis Clinical Trials — Los Angeles, California, United States
• Orange County Research Center — Tustin, California, United States
• Horizons Clinical Research Center, LLC. — Denver, Colorado, United States
• MOORE Clinical Research, Inc. — Brandon, Florida, United States
• Advanced Medcial Research Institiute — Miami Lakes, Florida, United States
• Park Avenue Dermatology — Orange Park, Florida, United States
• International Clinical Research — Sanford, Florida, United States
• Lenus Research & Medical Group — Sweetwater, Florida, United States
• Marietta Dermatology Clinical Research, Inc. — Marietta, Georgia, United States
• MedaPhase, Inc. — Newnan, Georgia, United States
• Northwest Clinical Trials — Boise, Idaho, United States
• Glazer Dermatology — Buffalo Grove, Illinois, United States
• Northwestern University — Chicago, Illinois, United States
• Summit Dermatology — Oakbrook Terrace, Illinois, United States
• Dawes Fretzin Clinical Research Group. LLC — Indianapolis, Indiana, United States
• The Indiana Clinical Trials Center, PC — Plainfield, Indiana, United States
• Hamzavi Dermatology — Fort Gratiot, Michigan, United States
• MediSearch Clinical Trials — Saint Joseph, Missouri, United States
• Greenwich Village Dermatology — New York, New York, United States
• UHCMC Skin Study Center — Cleveland, Ohio, United States
• Paddington Testing Co., Inc. — Philadelphia, Pennsylvania, United States
• Invocare Clinical Research Center — West Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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