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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04450589
Other study ID # ALL-180001-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 11, 2018
Est. completion date October 23, 2018

Study information

Verified date June 2020
Source Arbor Life Labs
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

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Locations

Country Name City State
United States Biometrix San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Arbor Life Labs

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other To evaluate Safety and Tolerability of ALRV5XR To compare the rate of non-severe and severe adverse events in subjects treated with the ALRV5XR regimen versus placebo treatment 24 Weeks
Primary Change in terminal hair density from baseline to Week 24. The primary outcome will determine if the increase in terminal hair count per square centimeter from baseline to Week 24 in subjects on ALRV5XR therapy is superior to placebo, at a significance level of 5% (one tail). A two-sample t test will be used to compare differences in the mean increase in terminal hair count from baseline to Week 24 between study arms. 24 Weeks
Primary The percentage change in the terminal hair regrowth from baseline to Week 24. The primary outcome will determine if the percentage change in terminal hair count from baseline to Week 24 in subjects on ALRV5XR therapy is superior to placebo, at a significance level of 5% (one tail). A two-sample t test will be used to compare differences in the mean percentage increase in total terminal hair count from baseline to Week 24 between study arms. 24 Weeks
Secondary Change in terminal hair density from baseline The increase in terminal hair count per square centimeter from baseline to Week 24 in subjects on ALRV5XR therapy is superior to placebo, at a significance level of 5% (one tail). A two-sample t test will be used to compare differences in the mean increase in terminal hair count from baseline to Week 12 between study arms. Week 12
Secondary The percentage change in the terminal hair regrowth from baseline to Week 12. The percentage change in terminal hair count Week 12
Secondary Change from baseline in hair width. Change from baseline in hair width, as measured by macrophotography [Time Frame: Week 12 and 24 Week 12 and 24
Secondary Proportion of subjects achieving a =25% increase in hair number count Proportion of subjects achieving a =25% increase in hair number count from baseline in the area being examined, as measured by macrophotography Week 12 and 24
Secondary Proportion of subjects achieving a =50% increase in hair number count Proportion of subjects achieving a =50% increase in hair number count from baseline in the area being examined, as measured by macrophotography Week 12 and 24
Secondary Proportion of subjects achieving a =75% increase in hair number count Proportion of subjects achieving a =75% increase in hair number count from baseline in the area being examined, as measured by macrophotography Week 12 and 24
Secondary Proportion of subjects achieving a =25% increase in Severity of Alopecia Tool (SALT) scores Proportion of subjects achieving a =25% increase in Severity of Alopecia Tool (SALT) scores from baseline. (SALT scores measure scalp hair loss for terminal hair only: 0: no hair loss; 1: 1-24% hair loss; 2: 25-49% hair loss; 3: 50-74% hair loss; 4: 75-99% hair loss, (4A: 75-90% hair loss, 4B: 91-99% hair loss); 5: 100% hair loss.) Week 12 and 24
Secondary Proportion of subjects achieving a =50% increase in Severity of Alopecia Tool (SALT) scores Proportion of subjects achieving a =50% increase in Severity of Alopecia Tool (SALT) scores from baseline. (SALT scores measure scalp hair loss for terminal hair only: 0: no hair loss; 1: 1-24% hair loss; 2: 25-49% hair loss; 3: 50-74% hair loss; 4: 75-99% hair loss, (4A: 75-90% hair loss, 4B: 91-99% hair loss); 5: 100% hair loss.) Week 12 and 24
Secondary Proportion of subjects achieving a =75% increase in Severity of Alopecia Tool (SALT) scores Proportion of subjects achieving a =75% increase in Severity of Alopecia Tool (SALT) scores from baseline. (SALT scores measure scalp hair loss for terminal hair only: 0: no hair loss; 1: 1-24% hair loss; 2: 25-49% hair loss; 3: 50-74% hair loss; 4: 75-99% hair loss, (4A: 75-90% hair loss, 4B: 91-99% hair loss); 5: 100% hair loss.) Week 12 and 24
Secondary Change in anagen/telogen ratio Change in anagen/telogen ratio from baseline to weeks 12 and 24 Week 12 and 24
Secondary Dermatology Life Quality Index (DLQI) score Dermatology Life Quality Index (DLQI) score. (0, no regrowth; 1, <25% of regrowth; 2, 25%-49% of regrowth; 3, 50%-74% of regrowth; 4, 75%-99% of re- growth; 5, 100% of regrowth) Week 12 and 24
Secondary Proportion of subjects achieving a DLQI patient global assessment score of 3 or above Proportion of subjects achieving a DLQI patient global assessment score of 3 or above at week 24 (0, no regrowth; 1, <25% of regrowth; 2, 25%-49% of regrowth; 3, 50%-74% of regrowth; 4, 75%-99% of re- growth; 5, 100% of regrowth) Week 12 and 24
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