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

NCT04450589 | Completed DMC

• 1 other identifier: ALL-180001-01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Androgenetic Alopecia; Androgenic Alopecia; Telogen Effluvium; Thinning Hair; Hair Loss/Baldness; Hair Thinning

Keywords

Androgenetic Alopecia; Androgenic Alopecia; Alopecia; Androgenetic; Androgenic; Telogen; Telogen Effluvium; Hair Loss; Baldness; Male Patterned Balding; Aging; Ageing; Senescence; Wnt; Wnt Beta-catenin Signaling Pathway; Stem Cell

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (12)

• Change in terminal hair density from baseline

  Week 12

• The percentage change in the terminal hair regrowth from baseline to Week 12.

  Week 12

• Change from baseline in hair width.

  Week 12 and 24

• Proportion of subjects achieving a ≥25% increase in hair number count

  Week 12 and 24

• Proportion of subjects achieving a ≥50% increase in hair number count

  Week 12 and 24

Other Outcomes (1)

• To evaluate Safety and Tolerability of ALRV5XR

  24 Weeks

Study Arms (2)

ALRV5XR

ACTIVE COMPARATOR

The ALRV5XR (active) group will receive ALRV5XR active treatment. Study agents will have randomized codes. Supplement capsules, shampoo, conditioner and scalp serum will all be similar in look and scent to the placebo products.

Dietary Supplement: ALRV5XR; Other: ALRV5XR Shampoo; Other: ALRV5XR Conditioner; Other: ALRV5XR Hair Follicle Serum (Nutriment)

Placebo

PLACEBO COMPARATOR

The Placebo group will receive a placebo (vehicle) treatment. Study agents will have randomized codes. Supplement capsules, shampoo, conditioner and scalp serum will all be similar in look and scent to the active products. The placebo shampoo, conditioner and serum will have the same base materials (vehicle) as their counterparts but will not contain active ingredients, and will therefore be similar in viscosity and color.

Dietary Supplement: Placebo; Other: Placebo Shampoo; Other: Placebo Conditioner; Other: Placebo Hair Follicle Serum (Nutriment)

Interventions

ALRV5XR DIETARY_SUPPLEMENT

ALRV5XR oral supplement. Dose/Route/Schedule: 1 capsule/oral twice daily. Take one capsule in the morning and one capsule in the evening. Take 30-60 minutes before food. If stomach upset occurs, subjects will be instructed to take the capsule at the beginning of a meal. There should be no deviation from the daily nutriment regimen (although in the event a capsule or day is missed, subject should continue with regimen the following day.)

Also known as: Replenology, Replenology Hair, 21 To Grow, Nutrient Replenishment Biology, Replenology Hair Professional, Replenology Professional, Replenology Restore

ALRV5XR

ALRV5XR Shampoo OTHER

ALRV5XR Shampoo. Dose/Route/Schedule: 3-7 ml, topical, daily. The amount of shampoo used will vary by subject, based on length of hair. Short hair will use approximately 3ml of shampoo per wash and long hair as much as 7 ml. For short hair, an amount equivalent to a quarter in the palm of a hand, and for long hair a half-dollar size. There should be no deviation from the daily nutriment regimen (although in the event a day is missed, subject should continue with regimen the following day

Also known as: Replenology, Replenology Hair, Replenology Shampoo, Nutrient Replenishment Biology, 21 To Grow, Replenology Retain

ALRV5XR

ALRV5XR Conditioner OTHER

ALRV5XR Conditioner. Dose/Route/Schedule: 3-7 ml, topical, daily. The amount of conditioner used will vary by subject based on length of hair. Short hair will use approximately 3ml of conditioner per wash and long hair as much as 7 ml. For short hair, an amount equivalent to a quarter in the palm of a hand, and for long hair a half-dollar size. There should be no deviation from the daily nutriment regimen (although in the event a day is missed, subject should continue with regimen the following day

Also known as: Replenology, Replenology Hair, Replenology Conditioner, Nutrient Replenishment Biology, 21 To Grow, Replenology Reinforce

ALRV5XR

ALRV5XR Hair Follicle Serum (Nutriment) OTHER

ALRV5XR topical Hair Follicle serum (Nutriment), sealed in an airless pump dispensing bottle, metered at 0.2ml per depression. Dose/Route/Schedule: 1ml, topical, daily, applied at night. Topical serum (referred to as the Nutriment) dosage is metered as 5 x depressions of plunger per day to cover areas of thinning scalp and adjacent scalp areas. Care should be taken to limit the Nutriment in hair. Each depression is metered at 0.2ml for a daily dose of 1.0 ml. Each container has 30ml of Nutriment. Nutriment will dry within a few minutes and any on the hair will also dry. The dried effect in the hair should not cause oiliness or dryness on scalp or hair. There should be no deviation from the daily nutriment regimen (although in the event a day is missed, subject should continue with regimen the following day.)

Also known as: Replenology, Replenology Follicle Nutriment, Replenology Hair, Nutrient Replenishment Biology, 21 To Grow, Replenology Revitalize, Replenology Scalp Serum

ALRV5XR

Placebo DIETARY_SUPPLEMENT

Placebo oral supplement. Dose/Route/Schedule: 1 capsule/oral twice daily. Take one capsule in the morning and one capsule in the evening. Take 30-60 minutes before food. If stomach upset occurs, subjects will be instructed to take the capsule at the beginning of a meal. There should be no deviation from the daily nutriment regimen (although in the event a capsule or day is missed, subject should continue with regimen the following day.)

Placebo

Placebo Shampoo OTHER

Placebo Shampoo. Dose/Route/Schedule: 3-7 ml, topical, daily. The amount of shampoo used will vary by subject, based on length of hair. Short hair will use approximately 3ml of shampoo per wash and long hair as much as 7 ml. For short hair, an amount equivalent to a quarter in the palm of a hand, and for long hair a half-dollar size. There should be no deviation from the daily nutriment regimen (although in the event a day is missed, subject should continue with regimen the following day

Placebo

Placebo Conditioner OTHER

Placebo Conditioner. Dose/Route/Schedule: 3-7 ml, topical, daily. The amount of conditioner used will vary by subject based on length of hair. Short hair will use approximately 3ml of conditioner per wash and long hair as much as 7 ml. For short hair, an amount equivalent to a quarter in the palm of a hand, and for long hair a half-dollar size. There should be no deviation from the daily nutriment regimen (although in the event a day is missed, subject should continue with regimen the following day

Placebo

Placebo Hair Follicle Serum (Nutriment) OTHER

Placebo topical Hair Follicle serum (Nutriment), sealed in an airless pump dispensing bottle, metered at 0.2ml per depression. Dose/Route/Schedule: 1ml, topical, daily, applied at night. Topical serum (referred to as the Nutriment) dosage is metered as 5 x depressions of plunger per day to cover areas of thinning scalp and adjacent scalp areas. Care should be taken to limit the Nutriment in hair. Each depression is metered at 0.2ml for a daily dose of 1.0 ml. Each container has 30ml of Nutriment. Nutriment will dry within a few minutes and any on the hair will also dry. The dried effect in the hair should not cause oiliness or dryness on scalp or hair. There should be no deviation from the daily nutriment regimen (although in the event a day is missed, subject should continue with regimen the following day.)

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:

• Female
• 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 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.
• 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).
• 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.

Sponsors & Collaborators

• Arbor Life Labs: lead

Study Sites (1)

Biometrix

San Francisco, California, 94127, United States

Location

Related Publications (1)

• Feldman PR, Fiebig KM, Piwko C, Mints BM, Brown D, Cahan DJ, Guevara-Aguirre J. Safety and efficacy of ALRV5XR in men with androgenetic alopecia: A randomised, double-blinded, placebo-controlled clinical trial. EClinicalMedicine. 2021 Sep 11;40:101124. doi: 10.1016/j.eclinm.2021.101124. eCollection 2021 Oct.

  PMID: 34541479 DERIVED

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Luciano Marra (Medical Director), PhD

  Arbor Life Labs

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study agents will have randomized codes. Supplement capsules, shampoo, conditioner and scalp serum will all be similar in look and scent to the active products. The placebo shampoo, conditioner and serum will have the same base materials as their counterparts but will not contain active ingredients, and will therefore be similar in viscosity and color.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized into 1 of 2 parallel groups. There will be one (1) treatment group and one (1) placebo group. Subjects will receive either the ALRV5XR treatment regimen or placebo regimen.

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: June 29, 2020
• Study Start: April 11, 2018
• Primary Completion: October 23, 2018
• Study Completion: October 23, 2018
• Last Updated: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After publication
• Access Criteria: Contact Sponsor

Locations

US (1)