A Study Evaluating the Hair Regrowth Efficacy and Safety of ALRV5XR in Male Subjects With Hair Loss (REBOOT-MEN)
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| ClinicalTrials.gov Identifier: NCT04450589 |
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Recruitment Status :
Completed
First Posted : June 29, 2020
Last Update Posted : June 30, 2020
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Androgenetic Alopecia Androgenic Alopecia Telogen Effluvium Thinning Hair Hair Loss/Baldness Hair Thinning | Dietary Supplement: ALRV5XR Other: ALRV5XR Shampoo Other: ALRV5XR Conditioner Other: ALRV5XR Hair Follicle Serum (Nutriment) Dietary Supplement: Placebo Other: Placebo Shampoo Other: Placebo Conditioner Other: Placebo Hair Follicle Serum (Nutriment) | Not Applicable |
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| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 46 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | 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. |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | 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. |
| Primary Purpose: | Treatment |
| Official Title: | Hair Regrowth Efficacy of Multi-Molecular Targeting Treatment (ALRV5XR), a Randomized Controlled Clinical Trial in Men With Androgenetic Alopecia, Telogen Effluvium or Self Reported Thinning Hair: THE HAIR REBOOT TRIAL - MEN |
| Actual Study Start Date : | April 11, 2018 |
| Actual Primary Completion Date : | October 23, 2018 |
| Actual Study Completion Date : | October 23, 2018 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: ALRV5XR
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.
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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 Names:
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 Names:
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 Names:
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.) Other Names:
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Placebo Comparator: Placebo
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.
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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.) |
- Change in terminal hair density from baseline to Week 24. [ Time Frame: 24 Weeks ]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.
- The percentage change in the terminal hair regrowth from baseline to Week 24. [ Time Frame: 24 Weeks ]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.
- Change in terminal hair density from baseline [ Time Frame: Week 12 ]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.
- The percentage change in the terminal hair regrowth from baseline to Week 12. [ Time Frame: Week 12 ]The percentage change in terminal hair count
- Change from baseline in hair width. [ Time Frame: Week 12 and 24 ]Change from baseline in hair width, as measured by macrophotography [Time Frame: Week 12 and 24
- Proportion of subjects achieving a ≥25% increase in hair number count [ Time Frame: Week 12 and 24 ]Proportion of subjects achieving a ≥25% increase in hair number count from baseline in the area being examined, as measured by macrophotography
- Proportion of subjects achieving a ≥50% increase in hair number count [ Time Frame: Week 12 and 24 ]Proportion of subjects achieving a ≥50% increase in hair number count from baseline in the area being examined, as measured by macrophotography
- Proportion of subjects achieving a ≥75% increase in hair number count [ Time Frame: Week 12 and 24 ]Proportion of subjects achieving a ≥75% increase in hair number count from baseline in the area being examined, as measured by macrophotography
- Proportion of subjects achieving a ≥25% increase in Severity of Alopecia Tool (SALT) scores [ Time Frame: Week 12 and 24 ]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.)
- Proportion of subjects achieving a ≥50% increase in Severity of Alopecia Tool (SALT) scores [ Time Frame: Week 12 and 24 ]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.)
- Proportion of subjects achieving a ≥75% increase in Severity of Alopecia Tool (SALT) scores [ Time Frame: Week 12 and 24 ]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.)
- Change in anagen/telogen ratio [ Time Frame: Week 12 and 24 ]Change in anagen/telogen ratio from baseline to weeks 12 and 24
- Dermatology Life Quality Index (DLQI) score [ Time Frame: Week 12 and 24 ]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)
- Proportion of subjects achieving a DLQI patient global assessment score of 3 or above [ Time Frame: Week 12 and 24 ]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)
- To evaluate Safety and Tolerability of ALRV5XR [ Time Frame: 24 Weeks ]To compare the rate of non-severe and severe adverse events in subjects treated with the ALRV5XR regimen versus placebo treatment
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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.
- 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.
Exclusion Criteria:
- 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.
- Use of anabolic steroids or 5-alpha reductase inhibitors in 6 months prior to the baseline visit (V2).
- Use of any products (prescription, OTC or natural health products) or devices reported and used to promote scalp hair growth (e.g., finasteride or minoxidil, L-Tyrosine) within 90 days prior to the Baseline Visit (V2).
- Use of any medications (including natural health products) that are known to potentially cause hair loss or affect hair growth within 30 days prior to the Baseline Visit (V2), as determined by PI.
- History of malignancy (in past 5 years) or undergoing chemotherapy or radiation treatments.
- A known history of autoimmune disease (e.g. HIV/AIDS, systemic lupus erythematosus, inflammatory bowel disease, alopecia areata, alopecia totalis, etc.), uncontrolled thyroid disease [hyperthyroidism, hypothyroidism; controlled will be permitted if no changes in dosage are required in the 6 months prior to screening (V1)], hepatitis C, or any other disorders that in the opinion of the investigator may interfere with the study treatment.
- Concurrent or within 3 months of baseline (V2) use of anti- inflammatory medication, corticosteroids, or immunosuppressive drugs taken for more than 2 consecutive weeks
- Active psychiatric disease (hospitalized within the past 12 months of Screening).
- Evidence of hepatic or renal dysfunction as evidenced by ALT or aspartate aminotransferase (AST) being ≥ 2 times the upper limit of normal or serum creatinine value ≥ 1.5X the upper limit of normal or other clinically significant abnormal clinical laboratory value, such that patient would be classified as stage 3b or greater of chronic kidney failure (eGFR below 60 ml/mjn/1.73 cm2, albumin-creatinine ratio(ACR) > 3.0 mg/mmol), under treatment for uncontrolled hypertension(HT) and other factors per PI discretion.
- History of drug or alcohol abuse in the past 12 months prior to Screening.
- Currently consuming more than 2 standard alcoholic beverages a day. A standard alcoholic beverage is defined as 12 ounces of beer, five (5) ounces of wine, or 1.5 ounces of liquor.
- Have a known sensitivity or allergy to any ingredients in the test products or placebo products.
- Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data.
- Participating in or has participated in another research study within 30 days prior to screening with any investigational medical product or natural health product
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04450589
| United States, California | |
| Biometrix | |
| San Francisco, California, United States, 94127 | |
| Study Director: | Luciano Marra (Medical Director), PhD | Arbor Life Labs |
| Responsible Party: | Arbor Life Labs |
| ClinicalTrials.gov Identifier: | NCT04450589 |
| Other Study ID Numbers: |
ALL-180001-01 |
| First Posted: | June 29, 2020 Key Record Dates |
| Last Update Posted: | June 30, 2020 |
| Last Verified: | June 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Data to support outcomes |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
| Time Frame: | After publication |
| Access Criteria: | Contact Sponsor |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 |
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Alopecia Alopecia Areata Hypotrichosis |
Hair Diseases Skin Diseases Pathological Conditions, Anatomical |