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Finasteride Treatment of Severe Nodulocystic Acne

Primary Purpose

NODULOCYSTIC ACNE

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Finasteride 23.5 mg tablets
Finasteride 33.5 mg tablets
Placebo tablets
Sponsored by
Elorac, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NODULOCYSTIC ACNE focused on measuring acne, nodulocystic, finasteride, 5 alpha reductase inhibitor

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Omni Dermatology, Inc.
  • Burke Pharmaceutical Research
  • Dr. Ronald Moy
  • Axis Clinical Trials
  • Orange County Research Center
  • Horizons Clinical Research Center, LLC.
  • MOORE Clinical Research, Inc.
  • Advanced Medcial Research Institiute
  • Park Avenue Dermatology
  • International Clinical Research
  • Lenus Research & Medical Group
  • Marietta Dermatology Clinical Research, Inc.
  • MedaPhase, Inc.
  • Northwest Clinical Trials
  • Glazer Dermatology
  • Northwestern University
  • Summit Dermatology
  • Dawes Fretzin Clinical Research Group. LLC
  • The Indiana Clinical Trials Center, PC
  • Hamzavi Dermatology
  • MediSearch Clinical Trials
  • Greenwich Village Dermatology
  • UHCMC Skin Study Center
  • Paddington Testing Co., Inc.
  • Invocare Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Finasteride 23.5 mg tablets group

Finasteride 33.5 mg tablets group

Placebo group

Arm Description

Finasteride 23.5mg tablets and large placebo tablets once per week

Finasteride 33.5 mg tablets and small placebo tablets once per week

Large and small placebo tablets once per week

Outcomes

Primary Outcome Measures

Acne Nodular Lesion Count
Change from Baseline to week 12 in the total number of nodular lesions

Secondary Outcome Measures

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

Full Information

First Posted
July 10, 2015
Last Updated
February 12, 2019
Sponsor
Elorac, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02502669
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
June 6, 2017 (Actual)
Study Completion Date
June 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elorac, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NODULOCYSTIC ACNE
Keywords
acne, nodulocystic, finasteride, 5 alpha reductase inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Finasteride 23.5 mg tablets group
Arm Type
Active Comparator
Arm Description
Finasteride 23.5mg tablets and large placebo tablets once per week
Arm Title
Finasteride 33.5 mg tablets group
Arm Type
Active Comparator
Arm Description
Finasteride 33.5 mg tablets and small placebo tablets once per week
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Large and small placebo tablets once per week
Intervention Type
Drug
Intervention Name(s)
Finasteride 23.5 mg tablets
Intervention Type
Drug
Intervention Name(s)
Finasteride 33.5 mg tablets
Intervention Type
Drug
Intervention Name(s)
Placebo tablets
Primary Outcome Measure Information:
Title
Acne Nodular Lesion Count
Description
Change from Baseline to week 12 in the total number of nodular lesions
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Proportion of Subjects who achieve at least a 75% reduction in total number of nodular lesions
Description
Change from Baseline to week 12 in the total number of nodular lesions
Time Frame
12 Weeks
Title
Investigator's Global Assessment Scale of Acne Severity
Description
Change from Baseline to week 12
Time Frame
12 Weeks
Title
Non-Inferiority (NI) for non-nodulocystic inflammatory lesions
Description
The NI bound will be larger of 10% reduction or a count of 4 lesions.
Time Frame
12 Weeks
Title
Change in total number of nodular lesions.
Description
Change from baseline to weeks 2, 4 and 8.
Time Frame
2, 4, and 8 weeks
Title
Proportion of subjects with 2 category improvement on Investigator's Global Assessment Scale
Description
Change from Baseline to week 12
Time Frame
12 Weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott B. Phillips, MD
Organizational Affiliation
Elorac, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Omni Dermatology, Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Dr. Ronald Moy
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Axis Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Horizons Clinical Research Center, LLC.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
MOORE Clinical Research, Inc.
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Advanced Medcial Research Institiute
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
Park Avenue Dermatology
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
International Clinical Research
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Lenus Research & Medical Group
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Marietta Dermatology Clinical Research, Inc.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
MedaPhase, Inc.
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Northwest Clinical Trials
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Glazer Dermatology
City
Buffalo Grove
State/Province
Illinois
ZIP/Postal Code
60089
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Summit Dermatology
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60181
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group. LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
The Indiana Clinical Trials Center, PC
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Hamzavi Dermatology
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
MediSearch Clinical Trials
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Greenwich Village Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10012
Country
United States
Facility Name
UHCMC Skin Study Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Paddington Testing Co., Inc.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Invocare Clinical Research Center
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Finasteride Treatment of Severe Nodulocystic Acne

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