Finasteride Treatment of Severe Nodulocystic Acne

NCT ID: NCT02502669

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-06-06

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.

Conditions

NODULOCYSTIC ACNE

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Finasteride 23.5 mg tablets group

Finasteride 23.5mg tablets and large placebo tablets once per week

Group Type: ACTIVE_COMPARATOR

Finasteride 23.5 mg tablets

Intervention Type: DRUG

Placebo tablets

Intervention Type: DRUG

Finasteride 33.5 mg tablets group

Finasteride 33.5 mg tablets and small placebo tablets once per week

Group Type: ACTIVE_COMPARATOR

Finasteride 33.5 mg tablets

Intervention Type: DRUG

Placebo tablets

Intervention Type: DRUG

Placebo group

Large and small placebo tablets once per week

Group Type: PLACEBO_COMPARATOR

Placebo tablets

Intervention Type: DRUG

Interventions

Finasteride 23.5 mg tablets

Intervention Type: DRUG

Finasteride 33.5 mg tablets

Intervention Type: DRUG

Placebo tablets

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Elorac, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott B. Phillips, MD

Role: STUDY_DIRECTOR

Elorac, Inc.

Locations

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

Countries

United States

Other Identifiers

EL-1006-01-01

Identifier Type: -

Identifier Source: org_study_id