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

Completed · Not applicable · Has a placebo group

Conditions studied: Androgenetic Alopecia, Androgenic Alopecia, Telogen Effluvium, Thinning Hair, Hair Loss/Baldness, Hair Thinning

In brief

To demonstrate that the ALRV5XR multi-molecular targeting treatment regimen of a daily shampoo, conditioner, topical serum and oral supplement is superior to placebo in promoting hair growth as assessed by change in hair density and percentage of terminal hair regrowth after ALRV5XR therapy. This will be a single-centre, double-blind, randomized, placebo-controlled study in female subjects randomized to a 1:1 ratio of test article to placebo. Subjects will be asked to use the study products on a daily basis for the duration of the 24-week study. Subjects will take one capsule twice daily (one in the morning and one in the evening) and will be asked to use 3-7mL of the shampoo, 3-7mL of the conditioner, and 1mL of the topical nutriment daily. Subjects will receive detailed instructions regarding the order and duration of application of each product. Subjects in the active arm will receive active capsules, shampoo, conditioner and topical nutriment. Subjects on placebo will receive placebo capsules, shampoo, conditioner and topical nutriment. All subjects will be instructed to take the capsules orally, one in the morning and one in the evening, prior to consuming food. Shampoo and conditioner are to be used once per day when washing the hair and nutriment applied at the end of the day prior to bedtime. To facilitate this, subjects will receive a 3-month supply of each product (supplement, shampoo, conditioner, and scalp nutriment). Subjects will continue the daily regimen for 24 weeks, visiting the clinic at week 12 for an interim assessment.

Key facts

Study ID

NCT04450602

Run by

Arbor Life Labs

People needed

46

Starts

2018-04-03

Expected to finish

2018-10-23

Last updated by the study team

2020-06-30

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women 18 - 65 years of age at time of screening (V1) (inclusive).
• Have androgenetic alopecia, diffuse hair loss or self-reported thinning or hair loss for more than 3 months prior to screening (V1).
• Clinically confirmed to have hair loss or thinning by the investigator via physical exam.
• In good general health, as determined by the Investigator.
• Willing and able to attend all study visits.
• Willing to maintain the same hair style as at the Screening Visit for the duration of the study.
• Have a negative urine pregnancy test at screening and be using, and continue to use for the duration of the study, an effective contraception method.
• Have Fitzpatrick skin type I-IV.
• Be willing and able to cooperate with the requirements of the study.
• Willingness to be photographed and provide consent for photographic release.
• Voluntarily sign and date an informed consent approved by the Institutional Review Board.
• Be able to complete and understand the various rating instruments in English.
• Sponsor approved global image assessment of degree of thinning / hair loss.

You may not qualify if…

• Male
• Clinical diagnosis of scarring forms of alopecia or alopecia areata.
• 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.
• Damage to the skin in or around the assessment areas.
• Scalp hair loss on the treatment area, due to disease, injury, or medical therapy.
• History of surgical correction of hair loss on the scalp - hair transplants or hair weave.
• 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
• In the opinion of the investigator have very little contrast between hair color and scalp that would make trichometric analyses difficult.
• Subjects who are pregnant or planning to become pregnant or are breastfeeding during the course of the study or subjects who are unwilling to use appropriate contraceptives for the duration of the study.
• 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.
• Presence of major diseases such as diabetes, endocrine, cardiovascular, renal, or liver disease.
• History of neurological disease (e.g. Parkinson's disease, stroke, traumatic brain injury, etc.).
• History of blood clotting disorders or current use of coagulation-inhibiting medications including natural health products (e.g. warfarin, St. John's wort).
• Recently started (<6 months) using hormone replacement therapy, including hormonal birth control. Stable dose >6 months will be permitted in the study.
• 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.
• Recently started (<6 months) using hormone replacement therapy.
• Use of anabolic steroids or 5-alpha reductase inhibitors in 6 months prior to the baseline visit (V2).
• 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 30 days prior to the Baseline Visit (V2).
• 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.
• History of malignancy (in past 5 years) or undergoing chemotherapy or radiation treatments.
• 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.
• Concurrent or within 3 months of baseline (V2) use of anti- inflammatory medication, corticosteroids, or immunosuppressive drugs taken for more than 2 consecutive weeks
• Active psychiatric disease (hospitalized within the past 12 months of Screening).
• 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.
• History of drug or alcohol abuse in the past 12 months prior to Screening.

Where it is running

• Biometrix — San Francisco, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.