A Study To Evaluate The Efficacy And Safety Of Clascoterone Solution In Treatment Of Male Pattern Hair Loss

Overview

About this study

The purpose of the study is to see if Clascoterone can help people with male pattern hair loss to recovery and see if the treatment is effective and safe and how well the drug is tolerated by subjects.  

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Subject can participate in this clinical study if all the following criteria are met:

1. Subject who is male ≥18 years old.

2. Subject who has provided written informed consent.

3. Subject who has mild to moderate AGA in temple and vertex region, rating III vertex to
V on the Modified Norwood-Hamilton Scale (i.e., III vertex [IIIv], IV, or V), with a
history of ongoing hair loss.

4. Subject who is willing to maintain the same hairstyle, hair length and hair color
throughout the study.

5. Subject who is willing to comply with study instructions at home and return to the
clinic for required visits.

6. Subject who agrees to continue his shampoo frequency and other general hair care
products and regimen for the entire study.

7. Subject who agrees to maintain same dietary and supplement pattern.

8. Subjects who are sexually active with a female partner and are not surgically sterile
(vasectomy performed at least 6 months prior to treatment) must agree to use an
acceptable form of birth control as described in the informed consent form. For
subjects, adequate forms of contraception include condom and spermicide in combination
with other forms of female contraception. For females, an acceptable method (Pearl
Index <1%) would be to agree to use implants, injectables, combined oral
contraceptives, some intrauterine devices, or be postmenopausal (defined as amenorrhea
greater than 12 consecutive months in women 50 years of age or older), be surgically
sterile (hysterectomy, bilateral tubal ligation [at least 6 months prior], or
bilateral oophorectomy).

Exclusion Criteria:

Subjects who meet any of the following criteria are not eligible to participate in the
study:

1. Subject who has any dermatological disorders of the scalp in the target region with
the possibility of interfering with the application of the IMP or examination method,
such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema,
folliculitis, scars, or scalp atrophy.

2. Subject who has any skin pathology or condition that, in the investigator's opinion,
could interfere with the evaluation of the IMP or requires use of interfering topical,
systemic (e.g., uncontrolled thyroid disease, certain genetic disorders that involve
hair growth or patterns), or surgical therapy.

3. Subject who has current or recent history (within 6 months) of hair weaves,
non-breathable wigs, or hair bonding.

4. Subject who had scalp hair transplants at any time.

5. Subject with a history of active hair loss due to diffuse telogen effluvium, alopecia
areata, scarring alopecia, trichotillomania, or conditions/diseases other than AGA.

6. Subject who has a current or recent history (within 6 months) of severe dietary or
weight changes or has a history of eating disorder(s), any history of bariatric
surgery (gastric bypass, gastric sleeve, stomach stapling); macro- or micro-nutrient
deficiencies within the last 6 months (i.e.: clinically significant iron deficiency,
protein deficiency confirmed by lab testing) and/or any current diagnosis of
malabsorptive disease (i.e.: Celiac, Irritable Bowel disease etc.).

7. Subject who has any condition which, in the investigator's opinion, would make it
unsafe for the subject to participate in this study, including 12-lead
electrocardiogram (ECG) findings during the screening period.

8. Subject is currently enrolled in an investigational drug or device study.

9. Subject who has used an investigational drug or investigational device treatment
within 30 days or 5 half-lives whichever is longer prior to Visit 2/Baseline.

10. Subject who is unable to communicate or cooperate with the investigator due to
language problems, poor mental development, or impaired cerebral function.

11. Subject who has used or is suspected, in the investigator's opinion, to be using
anabolic steroids.

12. Subject who may be unreliable for the study, including subjects who engage in
excessive alcohol intake or drug abuse, and/or subjects who will be unable to return
for scheduled follow-up visits.

13. Subject who has a known hypersensitivity or previous allergic reaction to any of the
active or inactive ingredients in the IMPs or tattoo ink.

14. Subject who has used any of the following topical preparations or procedures on the
scalp:

1. Topical scalp treatments for hair growth including minoxidil, Aminexil, hormone
therapy, anti-androgens, or other agents that are known to affect hair growth
within 12 weeks of Visit 2/Baseline.

2. Topical scalp over-the-counter (OTC) or cosmetic treatments known or reasonably
believed to affect hair growth (e.g., brands such as Maxilene, Nioxin, Foltene,
etc.) or hair health or hair growth products with saw palmetto, copper, etc.
within 2 weeks of Visit 2/Baseline.

3. Topical scalp treatments that may have ancillary effect on hair growth including,
but not limited to, corticosteroids, pimecrolimus, tacrolimus, and retinoids
within 4 weeks of Visit 2/Baseline.

4. Scalp procedures (surgical, laser, light, or energy treatments, micro-needling,
etc.) within 6 months of Visit 2/Baseline.

5. Platelet rich plasma (PRP) procedure on the scalp within 6 months of Visit
2/Baseline.

15. Subject who has used one or more of the following systemic medications or procedures:

1. Beta blockers, cimetidine, diazoxide, or corticosteroids (including intramuscular
and intralesional injections) within 12 weeks of Visit 2/Baseline. Inhaled,
intranasal, or ocular corticosteroids are allowed if use is stable [defined as
doses and frequency unchanged for at least 4 weeks prior to Visit 2/Baseline].

2. Retinoid, isotretinoin, vitamin A intake above 10,000 IU per day, or cyclosporine
therapy within 6 months of Visit 2/Baseline.

3. Any 5 alpha reductase medications (i.e.: Finasteride [Propecia®, etc.],
Dutasteride or similar products within 6 months of Visit 2/Baseline.

4. Chemotherapy or cytotoxic agents at any time.

5. Radiation of the scalp at any time point.

6. Other systemic therapy, which in the opinion of the investigator, may materially
affect the subject's hair or hair growth, including, but not limited to,
spironolactone, vitamin or homeopathy supplement hair growth or hair health
products or other steroid hormones (in any form), including anabolic steroids
during the 3 months prior to baseline or during the study.

16. Subject who has been previously enrolled in any study with Clascoterone (former CB 03
01).

17. Subject who is an employee or direct relative of an employee of the contract research
organization (CRO), the study site, or the Sponsor.

18. Subject who is institutionalized because of legal or regulatory order.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 6/20/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Alison Bruce, M.B., Ch.B.

Closed for enrollment

Contact information:

Alison Bruce

9049536076

bruce.alison@mayo.edu

More information

Publications

Publications are currently not available