Androgenetic AlopeciaPhase 2NCT02279823
A Phase 2 Study to Evaluate the Safety and Efficacy of CB-03-01 Solution, a Comparator Solution and Vehicle Solution in Males With Androgenetic Alopecia
A Phase 2 study testing CB-03-01 solution and Minoxidil Solution 5% in people with Androgenetic Alopecia, run by Intrepid Therapeutics, Inc. at 3 sites in United States.
Trial summary
In this proof-of-concept study, the safety and efficacy of a solution formulation will be investigated in male subjects with androgenetic alopecia (AGA) after twice daily application for up to 26 weeks. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- CB-03-01 solution and Minoxidil Solution 5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2014to May 2016
- 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 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Subject has mild to moderate androgenetic alopecia (AGA) in temple and vertex region
- Subject is willing to maintain the same hairstyle, hair length, and hair color throughout the study
- Subject agrees to continue his other general hair care products and regimen for the entire study
- Subjects who are sexually active with a female partner must be surgically sterile or agree to use an effective method of birth control from the first administration of the test article until 30 days after the last administration
Who cannot join
- Subject has any dermatological disorders of the scalp in the target region with the possibility of interfering with the application of the test article or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp atrophy
- Subject has any condition in the opinion of the investigator that could interfere with the evaluation of the test articles or requires the use of interfering topical or systemic therapy (e.g., uncontrolled thyroid disease, certain genetic disorders that involve hair growth or patterns)
- Subject has a current or recent history (within 3 months) of hair transplants, hair weaves or non-breathable wigs and hair bonding
- Subject has a current or recent history (within 3 months) of active hair loss due to diffuse telogen effluvium, alopecia areata, scarring alopecia, trichotillomania or conditions/diseases other than AGA
- Subject has a current or recent history (within 3 months) of severe dietary changes or presenting a history of eating disorder(s)
- Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study
Show all 21Show fewer
- Subject is currently enrolled in an investigational drug or device study
- Subject has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment
- Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function
- Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits
- The subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles or tattoo ink
- Subject has used any of the following topical preparations or procedures on the scalp:
- Topical treatments including corticosteroids, pimecrolimus, tacrolimus, minoxidil, hormone therapy, anti-androgens or other agents that are known to affect hair growth in the opinion of the investigator within 12 weeks of the initiation of treatment
- Topical over-the-counter (OTC) or cosmetic treatments known or reasonably believed to affect hair growth (e.g., brands such as Aminexil, Maxilene, Nioxin, Foltene, etc. or hair health or hair growth products with saw palmetto, copper, etc.) in the opinion of the investigator within 4 weeks of the initiation of treatment.
- Scalp procedures (surgical, laser, light or energy treatments, etc.) within 6 months of the initiation of treatment
- Subject has used the following systemic medications or procedures:
- Beta blockers, cimetidine, diazoxide, isotretinoin, vitamin A intake above 10000 IU per day or corticosteroids (including intramuscular and intralesional injections) within 12 weeks of the initiation of treatment. Inhaled, intranasal or ocular corticosteroids are allowed if use is stable (stable use is defined as dose and frequency unchanged for at least 4 weeks prior to the initiation of treatment)
- Retinoid, cyclosporine therapy within 6 months of the initiation of treatment
- Finasteride (Propecia®, etc.), dutasteride or a similar product(s) within 12 months of the initiation of treatment
- Chemotherapy, cytotoxic agents or radiation (of the scalp) within 12 months of the initiation of treatment
- Other systemic therapy which may materially affect the subject's hair or hair growth in the opinion of the investigator
Trial locations and contacts
3 sites in 1 country.
United States3 sites
DermResearch, Inc.
Austin, Texas, 78759
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Therapeutics Clinical Research
San Diego, California, 92123
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Safety and Efficacy of Cortexolone 17α-Propionate (CB-03-01) Solution 5%, Minoxidil Solution 5%, and Vehicle Solution, Applied Twice-daily for 26 Weeks in Males With Androgenetic Alopecia (AGA)
In this proof-of-concept study, the safety and efficacy of a solution formulation will be investigated in male subjects with androgenetic alopecia (AGA) after twice daily application for up to 26 weeks.
- Conditions
- Androgenetic Alopecia
- Being tested
- CB-03-01 solution, Minoxidil Solution 5%, Placebo solution
- Keywords
- androgen, alopecia, CB-03-01, solution, topical
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CB-03-01 solutionDrug
Also called cortexolone 17α-propionate
Investigational drug solution
Minoxidil Solution 5%Drug
FDA approved marketed product
Placebo solutionDrug
Vehicle solution
| Study group | Role | What they receive |
|---|---|---|
| CB-03-01 solution | Experimental | Topical solution applied twice daily for 26 weeks Receives: Drug: CB-03-01 solution |
| Minoxidil Solution 5% | Active comparator | Topical solution applied twice daily for 26 weeks Receives: Drug: Minoxidil Solution 5% |
| Placebo solution | Placebo comparator | Topical solution applied twice daily for 26 weeks Receives: Drug: Placebo solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Target Area Hair Count (TAHC)
Changes from Baseline in TAHC [in number of non-vellus hairs] using digital image analysis at Month 6.
Measured: Baseline and Month 6
Subject Self Assessment (Hair Growth Assessment [HGA])
The subject's evaluation of treatment benefit via the HGA questionnaires at Month 6. Scalp hair growth is compared from baseline using the following 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3).
Measured: Month 6
Secondary outcomes (4)
Change in Target Area Hair Width (TAHW)
Changes from Baseline in TAHW [in μm/cm2] using digital image analysis at Month 6.
Measured: Baseline and Month 6
Change in Target Area Hair Density (TAHD)
Changes from Baseline in TAHD [in intensity units] using digital image analysis at Month 6.
Measured: Baseline and Month 6
Subject evaluation of treatment benefit via the Hair Growth Index (HGI) and Hair Growth Satisfaction Scale (HGSS) questionnaires
The subject's evaluation of treatment benefit via the HGI and HGSS questionnaires at Month 6.
HGI: Hair growth is compared from baseline by three questions on a health outcome questionnaire, which are scored using the following 7-point scale: much less (-3), moderately less (-2), slightly less (-1), the same amount (0), slightly more (1), moderately more (2), much more (3).
HGSS: Hair appearance/growth is compared from baseline by five questions, which are scored using the following 7-point scale: very dissatisfied (-3), dissatisfied (-2), somewhat dissatisfied (-1), neutral/neither satisfied nor dissatisfied (0), somewhat satisfied (1), satisfied (2), very satisfied (3).
Measured: Month 6
Investigator's Global Assessment (IGA)
Compared to Baseline, the investigator will assess the subject's scalp hair growth using the following 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3).
Measured: Baseline, Month 2, 4 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies 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, Care provider, Investigator
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intrepid Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony Andrasfay, Study director, Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279823
- Sponsor's protocol ID
- 171-7152-201
- Status last verified
- Mar 2017
- First submitted
- 7 Oct 2014
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Safety and Efficacy of Cortexolone 17α-Propionate (CB-03-01) Solution 5%, Minoxidil Solution 5%, and Vehicle Solution, Applied Twice-daily for 26 Weeks in Males With Androgenetic Alopecia (AGA)
- ClinicalTrials.gov ID
- NCT02279823
- Acronym / sponsor ID
- 171-7152-201
- Conditions
- Androgenetic Alopecia
- Keywords
- androgen, alopecia, CB-03-01, solution, topical
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Intrepid Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 31 Oct 2014 (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.
In this proof-of-concept study, the safety and efficacy of a solution formulation will be investigated in male subjects with androgenetic alopecia (AGA) after twice daily application for up to 26 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CB-03-01 solution | Experimental | Drug: CB-03-01 solutionTopical solution applied twice daily for 26 weeks |
| Minoxidil Solution 5% | Active comparator | Drug: Minoxidil Solution 5%Topical solution applied twice daily for 26 weeks |
| Placebo solution | Placebo comparator | Drug: Placebo solutionTopical solution applied twice daily for 26 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject has mild to moderate androgenetic alopecia (AGA) in temple and vertex region
- Subject is willing to maintain the same hairstyle, hair length, and hair color throughout the study
- Subject agrees to continue his other general hair care products and regimen for the entire study
- Subjects who are sexually active with a female partner must be surgically sterile or agree to use an effective method of birth control from the first administration of the test article until 30 days after the last administration
Key exclusion criteria (21 listed)
- Subject has any dermatological disorders of the scalp in the target region with the possibility of interfering with the application of the test article or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp atrophy
- Subject has any condition in the opinion of the investigator that could interfere with the evaluation of the test articles or requires the use of interfering topical or systemic therapy (e.g., uncontrolled thyroid disease, certain genetic disorders that involve hair growth or patterns)
- Subject has a current or recent history (within 3 months) of hair transplants, hair weaves or non-breathable wigs and hair bonding
- Subject has a current or recent history (within 3 months) of active hair loss due to diffuse telogen effluvium, alopecia areata, scarring alopecia, trichotillomania or conditions/diseases other than AGA
- Subject has a current or recent history (within 3 months) of severe dietary changes or presenting a history of eating disorder(s)
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 |
|---|---|---|
| CB-03-01 solutionAlso: cortexolone 17α-propionateInvestigational drug solution | Drug | CB-03-01 solution |
| Minoxidil Solution 5%FDA approved marketed product | Drug | Minoxidil Solution 5% |
| Placebo solutionVehicle solution | Drug | Placebo solution |
Primary outcome
Change in Target Area Hair Count (TAHC)
Time frame: Baseline and Month 6
Changes from Baseline in TAHC [in number of non-vellus hairs] using digital image analysis at Month 6.
Subject Self Assessment (Hair Growth Assessment [HGA])
Time frame: Month 6
The subject's evaluation of treatment benefit via the HGA questionnaires at Month 6. Scalp hair growth is compared from baseline using the following 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3).
4 secondary outcomes
Change in Target Area Hair Width (TAHW)
Time frame: Baseline and Month 6
Change in Target Area Hair Density (TAHD)
Time frame: Baseline and Month 6
Subject evaluation of treatment benefit via the Hair Growth Index (HGI) and Hair Growth Satisfaction Scale (HGSS) questionnaires
Time frame: Month 6
Investigator's Global Assessment (IGA)
Time frame: Baseline, Month 2, 4 and 6
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 13 Mar 2017.
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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.
Anthony Andrasfay study director
Therapeutics, Inc.
3 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 CB-03-01 solution and Minoxidil Solution 5% in people with Androgenetic Alopecia, run by Intrepid Therapeutics, Inc. at 3 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 4 inclusion and 21 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 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Change in Target Area Hair Count (TAHC) (time frame: Baseline and Month 6). The study lists 2 primary outcomes in all. 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 13 Mar 2017.