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

Androgenetic Alopecia Clinical Trial

Official title: Hair Regrowth Efficacy of Multi-Molecular Targeting Treatment (ALRV5XR), a Randomized Controlled Clinical Trial in Women With Androgenetic Alopecia, Telogen Effluvium or Self Reported Thinning Hair: THE HAIR REBOOT TRIAL - WOMEN

Status Completed

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 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.

Clinical Trial Description

This is a prospective, randomized, double-blind, placebo-controlled, 2-arm parallel study to evaluate the efficacy and safety of a multi-molecular targeting botanical treatment regimen on parameters of hair growth, compared to placebo, in healthy female adults with androgenetic alopecia, diffuse hair loss or self-reported thinning hair.

Each study group will include 23 subjects. Subjects will be randomly assigned using computer generated randomization scheme to one of the two groups in a 1:1 ratio.

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 instructed to use 3-7mL of the shampoo, 3-7mL of the conditioner, and 1mL of the topical nutriment serum daily. Subjects will receive detailed instructions regarding the order, and duration of application of each product.

This trial will be conducted at one (1) American (USA) clinical research site. The duration of the study will be approximately 28 weeks (7 months), including the screening period. There will be a screening period of up to 28 days for eligibility assessment, followed by a baseline visit followed by a 24-week experimentation period for assessment of supplement effects. There will be a total of seven visits, including a screening visit, over this 28-week period.

The study will be conducted as outlined in this protocol and in compliance with the principles of the International Conference on Harmonization (ICH) Guidelines on Good Clinical Practice (GCP) (E.6), and the Declaration of Helsinki.

Prior to initiating any study-related procedures, each subject must provide written informed consent in accordance with Institutional Research Board (IRB) requirements and applicable regulations. Any potential subject will be contacted by a designated member of the research team at the study site. Potential subjects may complete a web-based pre-screening questionnaire or may be interviewed. During the interview (or web-based questionnaire), subjects will answer specific questions, in order to assess their eligibility. If they meet pre-screening requirements, they will be invited to schedule a screening visit (Visit 1) with a Study Coordinator no more than 30 days prior to the anticipated baseline visit (Visit 2). In the event that subjects' screening period exceeds 30 days, the Investigator may repeat blood work, biometrics and/or vital signs (as appropriate) to ensure that subjects remain eligible.

Visit 1 (Screening Visit):

At the screening visit (Visit 1), up to 30 days prior to the Baseline Visit (Visit 2), the overall details of the study and the procedures to be undertaken will be explained to the subject. The following information will be recorded and procedures carried out:

• Subject registration

• Informed Consent (copy to subject)

• Subject education/comprehension questionnaire

• Review inclusion & exclusion criteria

• Assess Fitzpatrick phototype skin classification

• Demographic data (dietary habits, race, ethnicity, age, etc.)

• Medical history

• Concomitant medications recorded

• Measure screening anthropometrics and vital signs: height (cm), weight (kg), temperature (°C) respiratory rate (breaths/min), blood pressure (mmHg) and heart rate (bpm).

• Calculate BMI (kg/m2)

• Scalp examination (including photographs) for each subject will include a screen for immediately observable medical issues and any scalp alopecia/scalp disorders; photography of hair (top, right side, left side, back) - photographs will be shared with the Sponsor for determination of eligibility to participate in the study.

• Physical examination (excluding breast, genital and anorectal exam)

• Collect fasting (>6h, nothing to eat or drink except water) blood for screening laboratory tests

• Provide the subject with an instruction handout explaining visit preparation and overall study requirements (provide written and verbal instructions).

Remind subjects to follow inclusion/exclusion criteria of restrictions for both OTC and prescription medications, maintain current dietary habits, sleep habits, exercise and sexual intercourse habits.

If the subject is eligible for the study, they will be given a date to attend the Site no more than 30 days after the screening visit.

Visit 2 (Baseline Visit) - Day 0 Inclusion/Exclusion Criteria will be re-assessed to ensure eligibility. Concomitant medications and adverse events will be reviewed. Eligible subjects will be randomized to one of the two treatment arms.

The following procedures will be completed prior to dosing:

• Monitor adverse events (since the previous visit)

• Review concomitant medications

• Measure anthropometrics and vital signs: weight (kg), temperature (°C) respiratory rate (breaths/min), blood pressure (mmHg) and heart rate (bpm)

• Calculate BMI (kg/m2)

• Review inclusion & exclusion criteria

• Scalp examination (including photographs) for each subject will include a screen for observable medical issues and any skin/scalp disorders; photography of hair (top, right side, left side, back) - photographs will be reviewed and SALT score determined by a dermatologist. General photographic instructions are described in APPENDIX III.

• Subjects will be asked to complete the Dermatology Quality of Life Index (DQLI)

• Use Trichology device to capture images of scalp target area for efficacy assessments

• Randomize eligible subjects

• Provide subject with the first dose of the oral supplement in clinic

The following procedures will be completed after dosing:

• Monitor subject for any immediate reactions (minimum 15-minute observation post- administration)

• Dispense 3-month supply of investigational product

• Provide subjects with instruction for using kit contents

• Remind subjects to follow inclusion/exclusion criteria for restrictions for both OTC and prescription medications, maintain current dietary habits, sleep habits, exercise and sexual intercourse habits.

• Provide subjects with a diary to record product use and any changes to health status or medication use

Visit 3 (Return for anagen/telogen ratio assessment) - day 3 Subjects will return to the clinic on day 3 to have the baseline anagen/telogen ratio assessed.

Visit 4 (Interim Visit) - Day 84 Study subjects will return to the Clinic on Day 84.

The following procedures will be completed:

• Collect daily diaries and review

• Collected investigational product containers (used and unused) and assess compliance

• Monitor adverse events (since the previous visit)

• Review concomitant medications (including changes to medications, changes to dose and frequency)

• Measure anthropometrics and vital signs: weight (kg), temperature (°C) respiratory rate (breaths/min), blood pressure (mmHg) and heart rate (bpm)

• Calculate BMI (kg/m2)

• Scalp examination (including photographs) for each subject will include a screen for observable medical issues and any skin/scalp disorders; photography of hair (top, right side, left side, back) - photographs will be reviewed and SALT score determined by a dermatologist.

• Subjects will be asked to complete the Dermatology Quality of Life Index (DQLI)

• Use Trichology device to capture images of scalp target area for efficacy assessments

• Collect blood for safety laboratory tests

• Dispense 3-month supply of investigational product

• Provide subjects with instruction for using kit contents

• Remind subjects to follow inclusion/exclusion criteria for restrictions for both OTC and prescription medications, maintain current dietary habits, sleep habits, exercise and sexual intercourse habits

• Provide subjects with a diary to record product use and any changes to health status or medication use

• Subjects will be booked for their next appointment

Visit 5 (Return for anagen/telogen ratio assessment) - day 87 Subjects will return to the clinic to have the anagen/telogen ratio assessed.

Visit 6 - Day 168 Study subjects will return to the Clinic on Day 168.

The following procedures will be completed:

• Collect daily diaries and review

• Collected investigational product containers (used and unused) and assess compliance

• Monitor adverse events (since the previous visit)

• Review concomitant medications (including changes to medications, changes to dose and frequency)

• Measure anthropometrics and vital signs: weight (kg), temperature (°C) respiratory rate (breaths/min), blood pressure (mmHg) and heart rate (bpm)

• Calculate BMI (kg/m2)

• Scalp examination (including photographs) for each subject will include a screen for observable medical issues and any skin/scalp disorders; photography of hair (top, right side, left side, back) - photographs will be reviewed and SALT score determined by a dermatologist.

• Subjects will be asked to complete the Dermatology Quality of Life Index (DQLI)

• Use Trichology device to capture images of scalp target area for efficacy assessments

• Collect blood for safety laboratory tests

Visit 7 (Return for anagen/telogen ratio assessment and end of study assessment) - day 171 Subjects will return to the clinic on day 3 to have the baseline anagen/telogen ratio assessed.

Early Termination/Discontinuation Visit

Subjects may elect to independently withdraw from participation in the study at any time. At a termination visit, subjects will be encouraged to undergo the procedures specified in the final study visit. Reasons for early termination/ discontinuation may include the subject developing any condition which contravenes the original criteria, or, at the discretion of the Principal Investigator (PI), the subject is considered to be unsuitable to continue the study. Individual subjects may have administration temporarily interrupted at the discretion of the PI, e.g. for adverse events (AE's) that are subsequently resolved. Subjects MUST have permanent discontinuation in the following situations:

• The subject had a Grade 3 (severe) or an investigational product-related SAE as determined by the PI

• Subject withdraws consent or refuses further assessment during the study

• Participation in another clinical trial

• Subject lost to follow-up

• Death

• Protocol violation

Unscheduled Visits Any study participant who contacts the investigation site about possible adverse events that are more than minor and/or that persist will be asked to visit the research centre for an assessment as appropriate.

Safety Tests Blood will be collected at V1, V4 and V6 for analysis of safety parameters. Anthropometrics and vital signs are being recorded at study visits number 1, 4, and 6 as measures of safety. Additionally, safety will be assessed by means of reported AEs.

Stopping Rules/Discontinuation The Investigator may withdraw any subject from this research if circumstances arise that warrant doing so. If a subject is withdrawn from the study for any reason, they will be asked to complete an early termination visit.

Permitted/Concomitant Medication(s) Subjects will be questioned about their medication history. The details of any medication taken will be recorded in the case notes and electronic Case Report Form (eCRF). Prescription and over-the-counter (OTC) medications (including supplements) not known to affect study endpoints are permitted.

Thyroid medications will be permitted where dosage has been stable for 6 months prior to the screening visit (V1) and subjects are not expected to have a dosage change during the study period.

Prohibited Medication(s)

Medications that are prohibited include:

• Anabolic steroids in prior 6 months and during the clinical study period

• 5-alpha reductase inhibitors in prior 6 months and during the clinical study period

• Products (including natural health products) and/or devices to promote scalp hair growth (e.g. finasteride, minoxidil, etc.) in 30 days prior to baseline (V2) and during the clinical study period

• Medications that are known to potentially cause hair loss or affect growth as determined by PI in 30 days prior to baseline (V2) and during the clinical study period

• Use of coagulation inhibiting medications (including natural health products) during the clinical study period

• Use of blood pressure lowering medications during the clinical study period

• Use of anti-inflammatory medications, corticosteroids or immunosuppressive drugs taken for more than 2 consecutive weeks in the 3 months prior to baseline (V2) and during the clinical study period

Rescue Medication(s) As this study is investigating the effects of a product in a healthy population, there are no rescue medications in this study.

SELECTION AND WITHDRAWAL OF SUBJECTS NUMBER OF STUDY PARTICIPANTS It is estimated that up to 70 subjects will be screened, in order to identify 46 suitable subjects.

WITHDRAWAL CRITERIA Subjects may withdraw from participation in a study at any time without consequence. If a subject withdraws from the study, the PI will make a reasonable effort to determine the reason for withdrawal from the study, which will be recorded on the eCRF, as will any AEs experienced by the subject.

Personal reasons (Subject-initiated): Participation in the study is optional, and a subject can withdraw from the study at any time, without consequence or prejudice.

Clinical judgment of PI: A subject could also be withdrawn from the study if, in the opinion of the PI, it is not in the subject's best interest to continue (e.g. AEs, need for prohibited medication, illness, etc.). All serious AEs (SAEs) will result in withdrawal from the trial.

Protocol violation: If a subject fails to comply with the protocol they may be removed at the discretion of the PI.

Reasons for withdrawal will be documented as one of the following:

W.1 Subject requests withdrawal from the study. W.2 Subject withdraws consent. W.3 AE makes the continuation of the subject in the study impossible or inadvisable.

W.4 Subject was incorrectly included in the study (discovered after enrollment not to have met the protocol entrance criteria). W.5 Subject is not complying with required study procedures. ;

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia
• Androgenic Alopecia
• Hair Loss/Baldness
• Hair Thinning
• Telogen Effluvium
• Thinning Hair

• NCT number: NCT04450602
• Study type: Interventional
• Source: Arbor Life Labs
• Status: Completed
• Phase: N/A
• Start date: April 3, 2018
• Completion date: October 23, 2018