NODULOCYSTIC ACNEPhase 2NCT02502669
Finasteride Treatment of Severe Nodulocystic Acne
A Phase 2 study testing Finasteride 23.5 mg tablets and Finasteride 33.5 mg tablets in people with NODULOCYSTIC ACNE, run by Elorac, Inc. at 25 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- NODULOCYSTIC ACNE
- What is being tested?
- Finasteride 23.5 mg tablets and Finasteride 33.5 mg tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 25 sitesUnited States
- Study dates
- Jul 2015to 6 Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Dr. Ronald Moy
Beverly Hills, California, 90210
Northwest Clinical Trials
Boise, Idaho, 83704
MOORE Clinical Research, Inc.
Brandon, Florida, 33511
Glazer Dermatology
Buffalo Grove, Illinois, 60089
Northwestern University
Chicago, Illinois, 60611
UHCMC Skin Study Center
Cleveland, Ohio, 44106
Horizons Clinical Research Center, LLC.
Denver, Colorado, 80220
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Dawes Fretzin Clinical Research Group. LLC
Indianapolis, Indiana, 46256
Axis Clinical Trials
Los Angeles, California, 90036
Marietta Dermatology Clinical Research, Inc.
Marietta, Georgia, 30060
Advanced Medcial Research Institiute
Miami Lakes, Florida, 33174
Greenwich Village Dermatology
New York, New York, 10012
MedaPhase, Inc.
Newnan, Georgia, 30263
Summit Dermatology
Oakbrook Terrace, Illinois, 60181
Park Avenue Dermatology
Orange Park, Florida, 32073
Paddington Testing Co., Inc.
Philadelphia, Pennsylvania, 19103
Omni Dermatology, Inc.
Phoenix, Arizona, 85018
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506
International Clinical Research
Sanford, Florida, 32771
Lenus Research & Medical Group
Sweetwater, Florida, 33172
Orange County Research Center
Tustin, California, 92780
Invocare Clinical Research Center
West Columbia, South Carolina, 29169
About this study
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
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.
Read the 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
- Being tested
- Finasteride 23.5 mg tablets, Finasteride 33.5 mg tablets, Placebo tablets
- Keywords
- acne, nodulocystic, finasteride, 5 alpha reductase inhibitor
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finasteride 23.5 mg tabletsDrug
Finasteride 33.5 mg tabletsDrug
Placebo tabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| Finasteride 23.5 mg tablets group | Active comparator | Finasteride 23.5mg tablets and large placebo tablets once per week Receives: Drug: Finasteride 23.5 mg tablets; Drug: Placebo tablets |
| Finasteride 33.5 mg tablets group | Active comparator | Finasteride 33.5 mg tablets and small placebo tablets once per week Receives: Drug: Finasteride 33.5 mg tablets; Drug: Placebo tablets |
| Placebo group | Placebo comparator | Large and small placebo tablets once per week Receives: Drug: Placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acne Nodular Lesion Count
Change from Baseline to week 12 in the total number of nodular lesions
Measured: 12 Weeks
Secondary outcomes (5)
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
Measured: 12 Weeks
Investigator's Global Assessment Scale of Acne Severity
Change from Baseline to week 12
Measured: 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.
Measured: 12 Weeks
Change in total number of nodular lesions.
Change from baseline to weeks 2, 4 and 8.
Measured: 2, 4, and 8 weeks
Proportion of subjects with 2 category improvement on Investigator's Global Assessment Scale
Change from Baseline to week 12
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startJul 2015
- Primary completion6 Jun 2017
- Study completion6 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NODULOCYSTIC ACNEStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elorac, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott B. Phillips, MD, Study director, Elorac, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502669
- Sponsor's protocol ID
- EL-1006-01-01
- Status last verified
- Feb 2019
- First submitted
- 10 Jul 2015
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02502669
- Acronym / sponsor ID
- EL-1006-01-01
- Conditions
- NODULOCYSTIC ACNE
- Keywords
- acne, nodulocystic, finasteride, 5 alpha reductase inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Elorac, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- 6 Jun 2017 (actual)
- Study completion
- 6 Jun 2017 (actual)
- First posted
- 20 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Finasteride 23.5 mg tablets group | Active comparator | Drug: Finasteride 23.5 mg tablets, Drug: Placebo tabletsFinasteride 23.5mg tablets and large placebo tablets once per week |
| Finasteride 33.5 mg tablets group | Active comparator | Drug: Finasteride 33.5 mg tablets, Drug: Placebo tabletsFinasteride 33.5 mg tablets and small placebo tablets once per week |
| Placebo group | Placebo comparator | Drug: Placebo tabletsLarge and small placebo tablets once per week |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finasteride 23.5 mg tablets | Drug | Finasteride 23.5 mg tablets group |
| Finasteride 33.5 mg tablets | Drug | Finasteride 33.5 mg tablets group |
| Placebo tablets | Drug | Finasteride 23.5 mg tablets group, Finasteride 33.5 mg tablets group, Placebo group |
Primary outcome
Acne Nodular Lesion Count
Time frame: 12 Weeks
Change from Baseline to week 12 in the total number of nodular lesions
5 secondary outcomes
Proportion of Subjects who achieve at least a 75% reduction in total number of nodular lesions
Time frame: 12 Weeks
Investigator's Global Assessment Scale of Acne Severity
Time frame: 12 Weeks
Non-Inferiority (NI) for non-nodulocystic inflammatory lesions
Time frame: 12 Weeks
Change in total number of nodular lesions.
Time frame: 2, 4, and 8 weeks
Proportion of subjects with 2 category improvement on Investigator's Global Assessment Scale
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott B. Phillips, MD study director
Elorac, Inc.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Finasteride 23.5 mg tablets and Finasteride 33.5 mg tablets in people with NODULOCYSTIC ACNE, run by Elorac, Inc. at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acne Nodular Lesion Count (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.