A Study Evaluating the Hair Regrowth Efficacy and Safety of ALRV5XR in Male Subjects With Hair Loss

Launched by ARBOR LIFE LABS · Jun 26, 2020

Keywords

ClinConnect Summary

This is a prospective, randomized, double-blind, placebo-controlled, 2-arm parallel study to evaluate the efficacy and safety of a multi-molecular targeting botanical treatment regimen on parameters of hair growth, compared to placebo, in healthy male adults with androgenetic alopecia, diffuse hair loss or self-reported thinning hair.

Each study group will include 23 subjects. Subjects will be randomly assigned using computer generated randomization scheme to one of the two groups in a 1:1 ratio.

Subjects will be asked to use the study products on a daily basis for the duration of the 24-...

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Men 18 - 65 years of age at time of screening (V1) (inclusive).
• • 2. Have androgenetic alopecia, diffuse hair loss or self-reported thinning or hair loss for more than 3 months prior to screening (V1).
• • 3. Clinically confirmed to have hair loss or thinning by the investigator via physical exam.
• • 4. In good general health, as determined by the Investigator.
• • 5. Willing and able to attend all study visits.
• • 6. Willing to maintain the same hair style as at the Screening Visit and refrain from chemical treatments on the hair for the duration of the study.
• • 7. Have Fitzpatrick skin type I-IV.
• • 8. Be willing and able to cooperate with the requirements of the study.
• • 9. Willingness to be photographed and provide consent for photographic release.
• • 10. Voluntarily sign and date an informed consent approved by the Institutional Review Board.
• • 11. Be able to complete and understand the various rating instruments in English.
• • 12. Sponsor approved global image assessment of degree of thinning / hair loss.
• Exclusion Criteria:
• • 1. Female
• • 2. Clinical diagnosis of scarring forms of alopecia or alopecia areata.
• • 3. Clinical diagnosis on the scalp of psoriasis, scaling, fungal or bacterial infection, lesions, follicular dermatitis, lice, flees or chemical burns, unusual thinning patches, traction alopecia or trichokryptomania, trichothiodystrophy, pili annulati, monilethrix or clear signs of trichodysmorphia, poor nutrition or hygiene.
• • 4. Damage to the skin in or around the assessment areas.
• • 5. Scalp hair loss on the treatment area, due to disease, injury, or medical therapy.
• • 6. History of surgical correction of hair loss on the scalp - hair transplants or hair weave.
• • 7. Are using or have used depilatories, razors, or wax on the scalp to an extent which, in the opinion of the investigator, may interfere with the performance of the study assessments
• • 8. In the opinion of the investigator have very little contrast between hair color and scalp that would make trichometric analyses difficult.
• • 9. Subjects who are planning a family and becoming pregnant with their partners during the course of the study or subjects who are unwilling to use appropriate contraceptives for the duration of the study.
• • 10. Current skin disease or conditions on the treatment area that, in the opinion of the Investigator, might put the subject at risk or interfere with the study conduct or evaluations.
• • 11. Presence of major diseases such as diabetes, endocrine, cardiovascular, renal, or liver disease.
• • 12. History of neurological disease (e.g. Parkinson's disease, stroke, traumatic brain injury, etc.).
• • 13. History of blood clotting disorders or current use of coagulation-inhibiting medications including natural health products (e.g. warfarin, St. John's wort).
• • 14. Hypertension defined as a seated resting systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg or current use of blood pressure lowering medications.
• • 15. Recently started (\<6 months) using hormone replacement therapy.
• • 16. Use of anabolic steroids or 5-alpha reductase inhibitors in 6 months prior to the baseline visit (V2).
• • 17. Use of any products (prescription, OTC or natural health products) or devices reported and used to promote scalp hair growth (e.g., finasteride or minoxidil, L-Tyrosine) within 90 days prior to the Baseline Visit (V2).
• • 18. Use of any medications (including natural health products) that are known to potentially cause hair loss or affect hair growth within 30 days prior to the Baseline Visit (V2), as determined by PI.
• • 19. History of malignancy (in past 5 years) or undergoing chemotherapy or radiation treatments.
• • 20. A known history of autoimmune disease (e.g. HIV/AIDS, systemic lupus erythematosus, inflammatory bowel disease, alopecia areata, alopecia totalis, etc.), uncontrolled thyroid disease \[hyperthyroidism, hypothyroidism; controlled will be permitted if no changes in dosage are required in the 6 months prior to screening (V1)\], hepatitis C, or any other disorders that in the opinion of the investigator may interfere with the study treatment.
• • 21. Concurrent or within 3 months of baseline (V2) use of anti- inflammatory medication, corticosteroids, or immunosuppressive drugs taken for more than 2 consecutive weeks
• • 22. Active psychiatric disease (hospitalized within the past 12 months of Screening).
• • 23. Evidence of hepatic or renal dysfunction as evidenced by ALT or aspartate aminotransferase (AST) being ≥ 2 times the upper limit of normal or serum creatinine value ≥ 1.5X the upper limit of normal or other clinically significant abnormal clinical laboratory value, such that patient would be classified as stage 3b or greater of chronic kidney failure (eGFR below 60 ml/mjn/1.73 cm2, albumin-creatinine ratio(ACR) \> 3.0 mg/mmol), under treatment for uncontrolled hypertension(HT) and other factors per PI discretion.
• • 24. History of drug or alcohol abuse in the past 12 months prior to Screening.
• • 25. Currently consuming more than 2 standard alcoholic beverages a day. A standard alcoholic beverage is defined as 12 ounces of beer, five (5) ounces of wine, or 1.5 ounces of liquor.
• • 26. Have a known sensitivity or allergy to any ingredients in the test products or placebo products.
• • 27. Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data.
• • 28. Participating in or has participated in another research study within 30 days prior to screening with any investigational medical product or natural health product