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

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ClinicalTrials.gov Identifier: NCT03676400
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Medipost Co Ltd.

Tracking Information
First Submitted Date  ICMJE September 12, 2018
First Posted Date  ICMJE September 18, 2018
Last Update Posted Date November 19, 2018
Actual Study Start Date  ICMJE October 2, 2018
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History Complete list of historical versions of study NCT03676400 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hair Growth Efficacy and Safety of NGF-574H in Adult With Androgenic Alopecia
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Product group / Control(placebo) group
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Androgenic Alopecia
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 16, 2018)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jangyoung(Jay) Lee, PhD 82-2-3465-6771 JAYLEE@medi-post.co.kr
Contact: Eun Su Jeon, PhD 82-2-3465-6771 esjeon@medi-post.co.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03676400
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Medipost Co Ltd.
Study Sponsor  ICMJE Medipost Co Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Byungcheol PARK, MD Dankook University
PRS Account Medipost Co Ltd.
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP