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
Primary Outcome
Change in mean total hair density (hair/cm2)
Secondary Outcome
Change in mean Telogen hair density
Condition
Androgenic Alopecia
Intervention
conditioned media of umbilical cord blood-derived stem cells
Study Arms / Comparison Groups
NGF-574H
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
84
Start Date
October 2, 2018
Completion Date
July 24, 2019
Primary Completion Date
July 22, 2019
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.
Gender
All
Ages
18 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
Byungcheol PARK, MD, ,
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT03676400
Organization ID
MP-CM-001
Responsible Party
Sponsor
Study Sponsor
Medipost Co Ltd.
Study Sponsor
Byungcheol PARK, MD, Principal Investigator, Dankook University
Verification Date
August 2019