Finasteride Treatment of Severe Nodulocystic Acne
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 18 - 35 |
Updated: | 2/17/2019 |
Start Date: | July 2015 |
End Date: | June 6, 2017 |
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.
safety of once weekly, high dose oral finasteride compared to placebo for the treatment of
severe nodulocystic acne in male subjects.
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.
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.
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
We found this trial at
25
sites
Boise, Idaho 83704
Principal Investigator: Diane McConnehey, DO
Phone: 208-685-0600
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4495 Hale Parkway
Denver, Colorado 80220
Denver, Colorado 80220
303-399-4067
Principal Investigator: Nancy Krywonis, MD
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819 E 1st St # 6
Sanford, Florida 32771
Sanford, Florida 32771
Principal Investigator: Rion Forconi, MD
Phone: 407-878-5830
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Beverly HIlls, California 90210
Principal Investigator: Ronald Moy, MD
Phone: 714-743-7432
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Brandon, Florida 33511
Principal Investigator: Susan Barker, MD
Phone: 813-948-7550
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Buffalo Grove, Illinois 60089
Principal Investigator: Scott Glazer, MD
Phone: 847-459-6611
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303 East Superior Street
Chicago, Illinois 60611
Chicago, Illinois 60611
Principal Investigator: Bethanee J. Schlosser, MD
Phone: 312-695-3613
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Cleveland, Ohio 44106
Principal Investigator: Elma Baron, MD
Phone: 216-844-7546
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Fort Gratiot, Michigan 48059
Principal Investigator: Fasahat Hamzavi, MD
Phone: 810-455-1612
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Hot Springs, Arkansas 71913
Principal Investigator: Dow Stough, MD
Phone: 501-620-4449
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Indianapolis, Indiana 46256
Principal Investigator: Kenneth Dawes, M.D.
Phone: 317-621-7731
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Los Angeles, California 90036
Principal Investigator: Lydie Hazan, MD
Phone: 310-289-8242
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Marietta, Georgia 30060
Principal Investigator: Mark Knautz, MD
Phone: 770-422-1013
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Miami Lakes, Florida 33174
Principal Investigator: Enrique Pelayo, M.D.
Phone: 208-346-8900
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New York, New York 10012
Principal Investigator: Robert Buka, MD
Phone: 212-385-3700
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Oakbrook Terrace, Illinois 60181
Principal Investigator: Rania Agha, MD
Phone: 630-474-4362
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Orange Park, Florida 32073
Principal Investigator: George Schmieder, DO
Phone: 904-458-0411
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Philadelphia, Pennsylvania 19103
Principal Investigator: Lawrence Parish, MD
Phone: 215-563-7330
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Phoenix, Arizona 85108
Principal Investigator: Andrew Racette`, DO
Phone: 480-889-1211
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Plainfield, Indiana 46168
Principal Investigator: Scott Guenthner, M.D.
Phone: 317-837-6082
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Sweetwater, Florida 33172
Principal Investigator: Felipe Gascon-Rodon, MD
Phone: 305-592-4692
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Tustin, California
Principal Investigator: Joel Neutel, MD
Phone: 208-552-8861
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West Columbia, South Carolina 29169
Principal Investigator: Patricia McClerklin, MD
Phone: 803-569-6166
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