Clinical trial NCT02502669: Finasteride Treatment of Severe Nodulocystic Acne
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: NODULOCYSTIC ACNE
Keywords: acne
nodulocystic
finasteride
5 alpha reductase inhibitor
Lead sponsor: Elorac, Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-20
Enrollment: 106
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: There will be 180 male subjects in this study. The study is composed of a Screening Period of up to 30 days during which inclusion / exclusion criteria will be reviewed, screening laboratory results will be obtained and medication washouts will be done as required. Subjects will complete the sexual function questionnaire and depression scale. A one day Baseline Period (Day 0), during which baseline assessments of acne lesion counts, physical examination and Investigator's Global Assessment Scale will be done. The Baseline Period will be followed by a 12-week randomized double-blind Treatment Period, in which subjects will be randomized into Finasteride 23.5 mg group, 33.5 mg group, or placebo group. During the Treatment Period, subjects will visit the study site Day 14, Day 28, and Day 56 for acne lesion counts and review of diaries, concomitant medications and adverse events. On Day 84 subjects will return to clinic for acne lesion counts and review of diaries, concomitant medications, adverse events and remaining study drug will be counted and collected. A physical exam and vital signs, Investigator Global Assessment, Subject Assessment of Efficacy, depression scale and sexual function questionnaire will be completed before the subject is discharged from the study.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Female subjects will be excluded from the study.
2. Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), pyoderma faciale, sinus tracks.
3. 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).
4. 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)
5. Subjects with current or history of prostatic disease including benign prostatic hypertrophy, or surgery on prostate.
6. 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.
7. Subjects with any skin disease or other condition that might interfere with the evaluation of nodular acne.
8. Known history or suspected carcinoma.
9. Allergy to finasteride or any other ingredients in the study medications.
10. Subjects with history in past 12 months of active addiction, abuse, misuse and/or dependence on drugs or alcohol.
11. Use of investigational drug within 90 days prior to Day 1

Primary outcomes:
measure: Acne Nodular Lesion Count
timeFrame: 12 Weeks
Secondary outcomes:
measure: Proportion of Subjects who achieve at least a 75% reduction in total number of nodular lesions
timeFrame: 12 Weeks
measure: Investigator's Global Assessment Scale of Acne Severity
timeFrame: 12 Weeks
measure: Non-Inferiority (NI) for non-nodulocystic inflammatory lesions
timeFrame: 12 Weeks
measure: Change in total number of nodular lesions.
timeFrame: 2, 4, and 8 weeks
measure: Proportion of subjects with 2 category improvement on Investigator's Global Assessment Scale
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Omni Dermatology, Inc.
state: Arizona
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Beverly Hills
country: United States
facility: Dr. Ronald Moy
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Denver
country: United States
facility: Horizons Clinical Research Center, LLC.
state: Colorado
city: Brandon
country: United States
facility: MOORE Clinical Research, Inc.
state: Florida
city: Miami Lakes
country: United States
facility: Advanced Medcial Research Institiute
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology
state: Florida
city: Sanford
country: United States
facility: International Clinical Research
state: Florida
city: Sweetwater
country: United States
facility: Lenus Research & Medical Group
state: Florida
city: Marietta
country: United States
facility: Marietta Dermatology Clinical Research, Inc.
state: Georgia
city: Newnan
country: United States
facility: MedaPhase, Inc.
state: Georgia
city: Boise
country: United States
facility: Northwest Clinical Trials
state: Idaho
city: Buffalo Grove
country: United States
facility: Glazer Dermatology
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Oakbrook Terrace
country: United States
facility: Summit Dermatology
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group. LLC
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, PC
state: Indiana
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: New York
country: United States
facility: Greenwich Village Dermatology
state: New York
city: Cleveland
country: United States
facility: UHCMC Skin Study Center
state: Ohio
city: Philadelphia
country: United States
facility: Paddington Testing Co., Inc.
state: Pennsylvania
city: West Columbia
country: United States
facility: Invocare Clinical Research Center
state: South Carolina
Study officials:
affiliation: Elorac, Inc.
name: Scott B. Phillips, MD
role: STUDY_DIRECTOR
References: