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

NACompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

April 11, 2018

Primary Completion Date

October 23, 2018

Study Completion Date

October 23, 2018

Conditions
Androgenetic AlopeciaAndrogenic AlopeciaTelogen EffluviumThinning HairHair Loss/BaldnessHair Thinning
Interventions
DIETARY_SUPPLEMENT

ALRV5XR

"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.)"

OTHER

ALRV5XR Shampoo

"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"

OTHER

ALRV5XR Conditioner

"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"

OTHER

ALRV5XR Hair Follicle Serum (Nutriment)

"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.)"

DIETARY_SUPPLEMENT

Placebo

"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.)"

OTHER

Placebo Shampoo

"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"

OTHER

Placebo Conditioner

"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"

OTHER

Placebo Hair Follicle Serum (Nutriment)

"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.)"

Trial Locations (1)

94127

Biometrix, San Francisco

All Listed Sponsors
lead

Arbor Life Labs

INDUSTRY

NCT04450589 - A Study Evaluating the Hair Regrowth Efficacy and Safety of ALRV5XR in Male Subjects With Hair Loss | Biotech Hunter | Biotech Hunter