Hair Growth Efficacy and Safety of NGF-574H in Adult With Androgenic Alopecia

• ClinicalTrials.gov Identifier: NCT03676400
• Recruitment Status: Completed
• First Posted: September 18, 2018
• Last Update Posted: August 12, 2019
• Sponsor: Medipost Co Ltd.
• Information provided by (Responsible Party): Medipost Co Ltd.

Tracking Information

• First Submitted Date: September 12, 2018
• First Posted Date: September 18, 2018
• Last Update Posted Date: August 12, 2019
• Actual Study Start Date: October 2, 2018
• Actual Primary Completion Date: July 22, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 16, 2018)

• Change in mean total hair density (hair/cm2) [ Time Frame: 0, 6, 12 and 24 weeks ]
  • The hair density by phototrichogram for 24 weeks application, in comparison to initial value (baseline) and/or placebo product.
  • Measurement of hair density by phototrichogram (Canfield): change in mean total hair density (hair/cm^2)
  • Statistical analysis: Time and product effects (p<0.05)
• Compare visual assessment before and after cosmetic treatment [ Time Frame: 0, 6, 12 and 24 weeks ]
  Visual Assessment using the clinical picture by an investigator: 7 point score (-3 to 3) Visual assessment by a subject (Self-Assessment): 7 point score (-3 to 3)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 16, 2018)

• Change in mean Telogen hair density [ Time Frame: 0, 6, 12 and 24 weeks ]
  Measurement of telogen hair density, in comparison to initial value (baseline) and/or placebo product.
• Change in mean Anagen hair density [ Time Frame: 0, 6, 12 and 24 weeks ]
  Measurement of anagen hair density, in comparison to initial value (baseline) and/or placebo product.
• Change in hair growth speed [ Time Frame: 0, 6, 12 and 24 weeks ]
  Measurement of hair growth speed, in comparison to initial value (baseline) and/or placebo product.
• Change in hair diameter [ Time Frame: 0, 6, 12 and 24 weeks ]
  Measurement of hair diameter, in comparison to initial value (baseline) and/or placebo product. Measure hair diameter using electronic outside micrometer.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Hair Growth Efficacy and Safety of NGF-574H in Adult With Androgenic Alopecia
• Official Title: Clinical Study for the Assessment of the Hair Growth Efficacy and Safety of a Cosmetic Investigational Product, After Repeated Applications for 24 Weeks, Under Normal Conditions of Use, in the Asian Adult Subjects With Androgenic Alopecia
• Brief Summary: The purpose of this study is to assess whether cosmetic investigational product containing NGF-574H is safe and effective in the treatment of androgenic alopecia in asian adults.
• Detailed Description: NGF-574H is a obtained by collection of paracrine factors secreted by human umbilical cord blood-derived mesenchymal stem cell that was exposed in vitro to an artificially designed environment mimicking alopecia state in hair follicles to prime the composition of the paracrine factors optimized for hair growth. This study is to assess and confirm whether NGF-574H is safe and effective in the treatment of androgenic alopecia in asian adults.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Product group / Control(placebo) group

Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care

• Condition: Androgenic Alopecia

Intervention

• Other: conditioned media of umbilical cord blood-derived stem cells
  Hair serum with 5% conditioned media of human umbilical cord blood-derived mesenchymal stem cells
  Other Name: NGF-574H
• Other: Placebo
  Hair serum without conditioned media of human umbilical cord blood-derived mesenchymal stem cells

Study Arms

• Experimental: NGF-574H

  NGF-574H is hair serum with 5% conditioned media of umbilical cord blood-derived stem cells containing various trophic factors that help alleviate hair loss.

  NGF-574H will be directed to use on hair and scalp by subject her/himself at home twice a day (in the morning and evening) for 24 weeks.

  Intervention: Other: conditioned media of umbilical cord blood-derived stem cells
• Placebo Comparator: placebo
  Hair serum without conditioned media of umbilical cord blood-derived stem cells will be directed to use on hair and scalp by subject her/himself at home twice a day (in the morning and evening) for 24 weeks.
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 9, 2019): 84
• Original Estimated Enrollment (submitted: September 16, 2018): 90
• Actual Study Completion Date: July 24, 2019
• Actual Primary Completion Date: July 22, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Origin: Asian (Korean)
2. Age: adult from 18 to 60 years old
3. Sex: female (minimum 70) and male
4. Understanding of the language spoken in the research center: subjects able to read the documents they are presented with and to hold to what they are explained.
5. Social cover: subjects having medical coverage
6. Subjects whose state of health, at the moment of inclusion, (auto-questionnaires and medical examinations for the recruitment, selection and inclusion), are compatible with this type of study.
7. Subjects can be pursuit and observation during the study period.

8. Subjects have a "hair loss grade" as below criteria:

   • BASP grade: Basic type (M2 to M3, or C2 to C3, or U1 to U3) or Specific type (V1 to V3, or F1 to F3)
   • For female: Ludwig grade: Ⅰ to Ⅱ
   • For male: Norwood-Hamilton grade: III to IV
   • Hair density by phototrichogram: 60 to 190 hair/cm2
   • Telogen hair ≥ 5%
9. Subject with hair length ≥3cm in the vertex region and intending to keep this minimum length during the whole study period.
10. Subject accepting the constraints of the phototrichogram technique, i.e. agreeing to have 1 shaved zone of 1.5cm2 on the scalp.
11. Subject agreeing not to apply any topical treatment (other than the investigational product) or take any oral product or nutritional supplementation, or have any diet known to improve scalp and/or hair qualities or reduce hair loss during the whole study period.
12. Subject agreeing to use a neutral shampoo (subject's own shampoo)
13. Subject agrees to have a tattoo on the scalp on phototrichogram evaluation area.
14. Subject presenting preferably with chestnut brown, dark or black hair (in order to avoid problems of contrast)

Exclusion Criteria:

1. Subject deprived from liberty by a judiciary or administrative decision, sick subject in situation of emergency.
2. Under age or off age subject protected by law, as well as those admitted to sanitary or social facilities, ever since the research can be performed in another manner.
3. Subject who cannot be contacted in case of emergency.
4. Females in pregnancy (positive urine pregnancy-tests performed at screening(visit 1 and visit 9)or nursing or without effective contraception method.
5. Subject with any systemic disorder or skin disease (e.g. scalp disorders such as seborrheic dermatitis or scalp psoriasis) or presenting genetic or hormonal alopecia.
6. Subject with a condition or receiving a medication which, in the opinion of the investigator, could compromise the safety of the subject or affect the outcome of the study.
7. Subject using topic cosmetic treatment or oral nutritional supplement likely to interfere on hair loss parameters during the last 3 months prior to the start of the study (screening)
8. Subject having a medical treatment likely to induce an alopecia or hypertrichosia, or having stopped it from than 3 months (including prostaglandins, rubefacients agents, all vasodilators, anti-androgens, all local hormonal treatment, etc...)
9. Subject following a long period (>30 days) treatment of anti-inflammatory during the last 4 months before the start of the study (screening)
10. Subject following a short period (<30 days) treatment of anti-inflammatory stopped or ongoing preceding the screening period.
11. Subject having a immunosuppressive and/or corticoids treatment during the 4 weeks preceding the screening period
12. Subject having dyed, bleached hair or with a permanent wave prior to study start.
13. Subject who have been exposed to excessive or intensive UV light (natural or artificial) prior to the study.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT03676400
• Other Study ID Numbers: MP-CM-001
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Medipost Co Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Medipost Co Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Byungcheol PARK, MD; Dankook University

• PRS Account: Medipost Co Ltd.
• Verification Date: August 2019