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

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.

Study Overview

• Status: Completed
• Conditions: NODULOCYSTIC ACNE
• Intervention / Treatment: Drug: Placebo tablets; Drug: Finasteride 23.5 mg tablets; Drug: Finasteride 33.5 mg tablets

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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Omni Dermatology, Inc.
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Burke Pharmaceutical Research
  • California
    • Beverly Hills, California, United States, 90210
      • Dr. Ronald Moy
    • Los Angeles, California, United States, 90036
      • Axis Clinical Trials
    • Tustin, California, United States, 92780
      • Orange County Research Center
  • Colorado
    • Denver, Colorado, United States, 80220
      • Horizons Clinical Research Center, LLC.
  • Florida
    • Brandon, Florida, United States, 33511
      • MOORE Clinical Research, Inc.
    • Miami Lakes, Florida, United States, 33174
      • Advanced Medcial Research Institiute
    • Orange Park, Florida, United States, 32073
      • Park Avenue Dermatology
    • Sanford, Florida, United States, 32771
      • International Clinical Research
    • Sweetwater, Florida, United States, 33172
      • Lenus Research & Medical Group
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Marietta Dermatology Clinical Research, Inc.
    • Newnan, Georgia, United States, 30263
      • MedaPhase, Inc.
  • Idaho
    • Boise, Idaho, United States, 83704
      • Northwest Clinical Trials
  • Illinois
    • Buffalo Grove, Illinois, United States, 60089
      • Glazer Dermatology
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Oakbrook Terrace, Illinois, United States, 60181
      • Summit Dermatology
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin Clinical Research Group. LLC
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center, PC
  • Michigan
    • Fort Gratiot, Michigan, United States, 48059
      • Hamzavi Dermatology
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • MediSearch Clinical Trials
  • New York
    • New York, New York, United States, 10012
      • Greenwich Village Dermatology
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • UHCMC Skin Study Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Co., Inc.
  • South Carolina
    • West Columbia, South Carolina, United States, 29169
      • Invocare Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Finasteride 23.5 mg tablets group; Finasteride 23.5mg tablets and large placebo tablets once per week	Drug: Placebo tablets; Drug: Finasteride 23.5 mg tablets
Active Comparator: Finasteride 33.5 mg tablets group; Finasteride 33.5 mg tablets and small placebo tablets once per week	Drug: Placebo tablets; Drug: Finasteride 33.5 mg tablets
Placebo Comparator: Placebo group; Large and small placebo tablets once per week	Drug: Placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acne Nodular Lesion Count	Change from Baseline to week 12 in the total number of nodular lesions	12 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects who achieve at least a 75% reduction in total number of nodular lesions	Change from Baseline to week 12 in the total number of nodular lesions	12 Weeks
Investigator's Global Assessment Scale of Acne Severity	Change from Baseline to week 12	12 Weeks
Non-Inferiority (NI) for non-nodulocystic inflammatory lesions	The NI bound will be larger of 10% reduction or a count of 4 lesions.	12 Weeks
Change in total number of nodular lesions.	Change from baseline to weeks 2, 4 and 8.	2, 4, and 8 weeks
Proportion of subjects with 2 category improvement on Investigator's Global Assessment Scale	Change from Baseline to week 12	12 Weeks

Collaborators and Investigators

• Sponsor: Elorac, Inc.
• Investigators: Study Director: Scott B. Phillips, MD, Elorac, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): June 6, 2017
• Study Completion (Actual): June 6, 2017

Study Registration Dates

• First Submitted: July 10, 2015
• First Submitted That Met QC Criteria: July 16, 2015
• First Posted (Estimate): July 20, 2015

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 12, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: acne; finasteride; 5 alpha reductase inhibitor; nodulocystic
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Urological Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; 5-alpha Reductase Inhibitors; Finasteride
• Other Study ID Numbers: EL-1006-01-01