Finasteride Treatment of Severe Nodulocystic Acne
A Double-Blind, Randomized, Placebo-Controlled Dose-Ranging Study Evaluating the Efficacy and Safety of Once Weekly High Dose Oral Finasteride in the Treatment of Severe Nodulocystic Acne
1 other identifier
interventional
106
1 country
25
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2015
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 10, 2015
CompletedFirst Posted
Study publicly available on registry
July 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2017
CompletedFebruary 15, 2019
February 1, 2019
1.9 years
July 10, 2015
February 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acne Nodular Lesion Count
Change from Baseline to week 12 in the total number of nodular lesions
12 Weeks
Secondary Outcomes (5)
Proportion of Subjects who achieve at least a 75% reduction in total number of nodular lesions
12 Weeks
Investigator's Global Assessment Scale of Acne Severity
12 Weeks
Non-Inferiority (NI) for non-nodulocystic inflammatory lesions
12 Weeks
Change in total number of nodular lesions.
2, 4, and 8 weeks
Proportion of subjects with 2 category improvement on Investigator's Global Assessment Scale
12 Weeks
Study Arms (3)
Finasteride 23.5 mg tablets group
ACTIVE COMPARATORFinasteride 23.5mg tablets and large placebo tablets once per week
Finasteride 33.5 mg tablets group
ACTIVE COMPARATORFinasteride 33.5 mg tablets and small placebo tablets once per week
Placebo group
PLACEBO COMPARATORLarge and small placebo tablets once per week
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elorac, Inc.lead
Study Sites (25)
Omni Dermatology, Inc.
Phoenix, Arizona, 85018, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913, United States
Dr. Ronald Moy
Beverly Hills, California, 90210, United States
Axis Clinical Trials
Los Angeles, California, 90036, United States
Orange County Research Center
Tustin, California, 92780, United States
Horizons Clinical Research Center, LLC.
Denver, Colorado, 80220, United States
MOORE Clinical Research, Inc.
Brandon, Florida, 33511, United States
Advanced Medcial Research Institiute
Miami Lakes, Florida, 33174, United States
Park Avenue Dermatology
Orange Park, Florida, 32073, United States
International Clinical Research
Sanford, Florida, 32771, United States
Lenus Research & Medical Group
Sweetwater, Florida, 33172, United States
Marietta Dermatology Clinical Research, Inc.
Marietta, Georgia, 30060, United States
MedaPhase, Inc.
Newnan, Georgia, 30263, United States
Northwest Clinical Trials
Boise, Idaho, 83704, United States
Glazer Dermatology
Buffalo Grove, Illinois, 60089, United States
Northwestern University
Chicago, Illinois, 60611, United States
Summit Dermatology
Oakbrook Terrace, Illinois, 60181, United States
Dawes Fretzin Clinical Research Group. LLC
Indianapolis, Indiana, 46256, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506, United States
Greenwich Village Dermatology
New York, New York, 10012, United States
UHCMC Skin Study Center
Cleveland, Ohio, 44106, United States
Paddington Testing Co., Inc.
Philadelphia, Pennsylvania, 19103, United States
Invocare Clinical Research Center
West Columbia, South Carolina, 29169, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Scott B. Phillips, MD
Elorac, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2015
First Posted
July 20, 2015
Study Start
July 1, 2015
Primary Completion
June 6, 2017
Study Completion
June 6, 2017
Last Updated
February 15, 2019
Record last verified: 2019-02