Hair Growth Efficacy and Safety of NGF-574H in Adult With Androgenic Alopecia
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Chung Nam
-
Cheonan, Chung Nam, Korea, Republic of, 31116
- Dankook University Hospital
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Origin: Asian (Korean)
- Age: adult from 18 to 60 years old
- Sex: female (minimum 70) and male
- 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.
- Social cover: subjects having medical coverage
- 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.
- Subjects can be pursuit and observation during the study period.
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%
- Subject with hair length ≥3cm in the vertex region and intending to keep this minimum length during the whole study period.
- Subject accepting the constraints of the phototrichogram technique, i.e. agreeing to have 1 shaved zone of 1.5cm2 on the scalp.
- 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.
- Subject agreeing to use a neutral shampoo (subject's own shampoo)
- Subject agrees to have a tattoo on the scalp on phototrichogram evaluation area.
- Subject presenting preferably with chestnut brown, dark or black hair (in order to avoid problems of contrast)
Exclusion Criteria:
- Subject deprived from liberty by a judiciary or administrative decision, sick subject in situation of emergency.
- 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.
- Subject who cannot be contacted in case of emergency.
- Females in pregnancy (positive urine pregnancy-tests performed at screening(visit 1 and visit 9)or nursing or without effective contraception method.
- 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.
- 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.
- 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)
- 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...)
- Subject following a long period (>30 days) treatment of anti-inflammatory during the last 4 months before the start of the study (screening)
- Subject following a short period (<30 days) treatment of anti-inflammatory stopped or ongoing preceding the screening period.
- Subject having a immunosuppressive and/or corticoids treatment during the 4 weeks preceding the screening period
- Subject having dyed, bleached hair or with a permanent wave prior to study start.
- Subject who have been exposed to excessive or intensive UV light (natural or artificial) prior to the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
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. |
Hair serum with 5% conditioned media of human umbilical cord blood-derived mesenchymal stem cells
Other Names:
|
|
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.
|
Hair serum without conditioned media of human umbilical cord blood-derived mesenchymal stem cells
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in mean total hair density (hair/cm2)
Time Frame: 0, 6, 12 and 24 weeks
|
|
0, 6, 12 and 24 weeks
|
|
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)
|
0, 6, 12 and 24 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
0, 6, 12 and 24 weeks
|
|
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.
|
0, 6, 12 and 24 weeks
|
|
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.
|
0, 6, 12 and 24 weeks
|
|
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.
|
0, 6, 12 and 24 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Byungcheol PARK, MD, Dankook University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- MP-CM-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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