| Eligibility |
Inclusion Criteria:
1. Subject is capable of giving informed consent and complying with study procedures;
2. Subject is male between the ages of 18 and 70 years, inclusive;
3. Subject has a clinical diagnosis of mild to moderate androgenetic alopecia; rating
IIIv, IV and V on the Norwood Hamilton Scale, with a history of ongoing hair loss;
4. Subject is willing to maintain the same hairstyle, hair length, and hair color
throughout the study
5. Subject agrees to continue his other general hair care products and regimen for the
entire study;
6. Subject is considered healthy by the Principal Investigator, based on a detailed
medical history, full physical examination, clinical laboratory tests, 12-lead ECG and
vital signs (systolic blood pressure =90 and
=150 mmHg, diastolic blood pressure =50 and =95 mmHg and pulse rate
=45 and =100 bpm; one repeat of results is allowed to evaluate out of range values);
7. Negative COVID-19 results within 3 days prior first dosing
Exclusion Criteria:
1. Subject has any dermatological disorders of the scalp in the target region with the
possibility of interfering with the application of the investigational drug, such as
fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema,
folliculitis, scars, or scalp atrophy;
2. Subject has any skin pathology or condition that, in the investigator's opinion, could
interfere with the evaluation of the investigational drug 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 has current or recent history (within 12 months) of hair weaves,
non-breathable wigs, or hair bonding;
4. Subject had scalp hair transplants at any time
5. Subject has a history or active hair loss due to diffuse telogen effluvium, alopecia
areata, scarring alopecia, trichotillomania, or conditions/ diseases other than AGA;
6. Subject has a current or recent history (within six months) of severe dietary or
weight changes or has a history of eating disorder(s); if such has resulted in hair
loss;
7. Any disorder, including but not limited to, cardiovascular, gastrointestinal, hepatic,
renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological,
psychiatric, or major physical impairment that is not stable in the opinion of the
Investigator and could:
- Affect the safety of the subject throughout the study
- Influence the findings of the studies or their interpretations
- Impede the subject's ability to complete the entire duration of study
8. Subject is currently enrolled in an investigational drug or device study;
9. Subject has used an investigational drug or investigational device treatment within 30
days prior to randomization;
10. Subject is unable to communicate or cooperate with the investigator due to language
problems, poor mental development, or impaired cerebral function;
11. Subject may be unreliable for the study including subjects who engage in excessive
alcohol intake or drug abuse (defined as any illicit drug use), or subjects who are
unable to return for scheduled follow-up visits;
12. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface
antigen (HBsAg), or hepatitis C virus (HCV) antibody;
13. Subject has a known hypersensitivity or previous allergic reaction to any of the
active or inactive ingredients in the investigational drug or tattoo ink.
14. Subject has used any of the following topical preparations or procedures on the scalp:
- Topical scalp treatments for hair growth including minoxidil, hormone therapy,
anti-androgens, or other agents that are known to affect hair growth within 12
weeks of randomization;
- Use of hair regrowth products, including minoxidil, for >4 continuous weeks
within 6 months before randomization;
- Medical shampoos or solutions which include Ketoconazole or the like (e.g.
Terzolin) within four weeks prior to randomization;
- Topical scalp 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. within four weeks of randomization;
- Topical scalp treatments that may have ancillary effect on hair growth including,
but not limited to, corticosteroids, pimecrolimus, tacrolimus, and retinoids
within four weeks of randomization;
- Scalp procedures (surgical, laser, light, or energy treatments, microneedling,
etc.) within six months of randomization;
- Platelet rich plasma (PRP) procedure on the scalp at any time point.
15. Subject has used the following systemic medications or procedures:
- Beta blockers, cimetidine, diazoxide, or corticosteroids (including intramuscular
and intralesional injections) within 12 weeks of randomization. Inhaled,
intranasal, or ocular corticosteroids are allowed if use is stable [defined as
doses and frequency unchanged for at least four weeks prior to randomization];
- Retinoid, isotretinoin, vitamin A intake above 10,000 IU per day, or cyclosporine
therapy within six months of randomization;
- Use of immunoglobulins/immunomodulators (eg, cyclosporin) for >4 continuous weeks
within 6 months of randomization,
- Use of 5-a-reductase inhibitors (eg, finasteride or dutasteride) and/ or
antiandrogens within 12 months before randomization;
- Use of systemic cimetidine or ketoconazole for >2 continuous weeks within 3
months before randomization;
- Chemotherapy or cytotoxic agents within 12 months of randomization;
- Radiation of the scalp at any time point;
- Use of systemic corticosteroids within 2 months of randomization for >2
consecutive weeks,
- 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, vitamin
or homeopathy supplement hair growth or hair health products or other steroid
hormones (in any form), including anabolic steroids;
16. An unwillingness of male participants to use highly effective contraceptive measures
if engaging in sexual intercourse with a female partner of childbearing potential.
Highly effective measures include use of a condom and spermicide and, for female
partners, use of an intrauterine device (IUD), diaphragm with spermicide, oral
contraceptives, injectable progesterone, progesterone subdermal implants, or a tubal
ligation.
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