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Finasteride Treatment of Severe Nodulocystic Acne

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ClinicalTrials.gov Identifier: NCT02502669
Recruitment Status : Completed
First Posted : July 20, 2015
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Elorac, Inc.

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.

Condition or disease Intervention/treatment Phase
NODULOCYSTIC ACNE Drug: Finasteride 23.5 mg tablets Drug: Finasteride 33.5 mg tablets Drug: Placebo tablets Phase 2

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  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2015
Actual Primary Completion Date : June 6, 2017
Actual Study Completion Date : June 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Finasteride

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



Primary Outcome Measures :
  1. Acne Nodular Lesion Count [ Time Frame: 12 Weeks ]
    Change from Baseline to week 12 in the total number of nodular lesions


Secondary Outcome Measures :
  1. Proportion of Subjects who achieve at least a 75% reduction in total number of nodular lesions [ Time Frame: 12 Weeks ]
    Change from Baseline to week 12 in the total number of nodular lesions

  2. Investigator's Global Assessment Scale of Acne Severity [ Time Frame: 12 Weeks ]
    Change from Baseline to week 12

  3. Non-Inferiority (NI) for non-nodulocystic inflammatory lesions [ Time Frame: 12 Weeks ]
    The NI bound will be larger of 10% reduction or a count of 4 lesions.

  4. Change in total number of nodular lesions. [ Time Frame: 2, 4, and 8 weeks ]
    Change from baseline to weeks 2, 4 and 8.

  5. Proportion of subjects with 2 category improvement on Investigator's Global Assessment Scale [ Time Frame: 12 Weeks ]
    Change from Baseline to week 12



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502669


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Sponsors and Collaborators
Elorac, Inc.
Investigators
Study Director: Scott B. Phillips, MD Elorac, Inc.

Responsible Party: Elorac, Inc.
ClinicalTrials.gov Identifier: NCT02502669     History of Changes
Other Study ID Numbers: EL-1006-01-01
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

Keywords provided by Elorac, Inc.:
acne
nodulocystic
finasteride
5 alpha reductase inhibitor

Additional relevant MeSH terms:
Finasteride
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Urological Agents