A Study Evaluating the Hair Regrowth Efficacy and Safety of ALRV5XR in Male Subjects With Hair Loss (NCT04450589) | Clinical Trial Compass
CompletedNot Applicable
A Study Evaluating the Hair Regrowth Efficacy and Safety of ALRV5XR in Male Subjects With Hair Loss
United States46 participantsStarted 2018-04-11
Plain-language summary
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 male 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.
Who can participate
Age range18 Years – 65 Years
SexMALE
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Inclusion criteria
✓. Men 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 and refrain from chemical treatments on the hair for the duration of the study.
✓. Have Fitzpatrick skin type I-IV.
✓. Be willing and able to cooperate with the requirements of the study.
Exclusion criteria
✕. Female
✕. Clinical diagnosis of scarring forms of alopecia or alopecia areata.
What they're measuring
1
Change in terminal hair density from baseline to Week 24.
Timeframe: 24 Weeks
2
The percentage change in the terminal hair regrowth from baseline to Week 24.
✕. 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.