Androgenic Alopecia Clinical Trial
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
NCT number | NCT03676400 |
Other study ID # | MP-CM-001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2, 2018 |
Est. completion date | July 24, 2019 |
Verified date | August 2019 |
Source | Medipost Co Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | July 24, 2019 |
Est. primary completion date | July 22, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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: ? to ? - 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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Dankook University Hospital | Cheonan | Chung Nam |
Lead Sponsor | Collaborator |
---|---|
Medipost Co Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in mean total hair density (hair/cm2) | 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) |
0, 6, 12 and 24 weeks | |
Primary | Compare visual assessment before and after cosmetic treatment | 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 | Change in mean Telogen hair density | Measurement of telogen hair density, in comparison to initial value (baseline) and/or placebo product. | 0, 6, 12 and 24 weeks | |
Secondary | Change in mean Anagen hair density | Measurement of anagen hair density, in comparison to initial value (baseline) and/or placebo product. | 0, 6, 12 and 24 weeks | |
Secondary | Change in hair growth speed | Measurement of hair growth speed, in comparison to initial value (baseline) and/or placebo product. | 0, 6, 12 and 24 weeks | |
Secondary | Change in hair diameter | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06110377 -
MALE HAIR LOSS - Treatment With Dutasteride Mesotherapy x Dutasteride MMP Technique (Injections With Tattoo Machine)
|
Phase 4 | |
Recruiting |
NCT05611593 -
Study to Evaluate Safety & Usability of a New Formulation for Male Androgenetic Alopecia
|
Phase 1 | |
Recruiting |
NCT05938569 -
Computer-Assisted Hair Restoration Study Using ARTAS System
|
N/A | |
Not yet recruiting |
NCT06326359 -
Autologous Stromal Vascular Fraction in Treatment of Male Androgenic Alopecia
|
N/A | |
Recruiting |
NCT05426629 -
Hydraderm for Androgenic Alopecia
|
Phase 4 | |
Recruiting |
NCT05369481 -
Comparison Between Efficacy of Topical Sildenafil 2% and Topical Minoxidil 5% in Treatment of Androgenic Alopecia
|
N/A | |
Recruiting |
NCT05827991 -
A Clinical Observation of 1565nm Non-ablative Fractional Laser in the Treatment of Androgenic Alopecia
|
N/A | |
Not yet recruiting |
NCT06292533 -
Effectiveness of Ultrapulse for the Treatment of Androgenic Alopecia Among Malaysian: A Quasi-experimental Study
|
N/A | |
Completed |
NCT02824380 -
Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects With Androgenic Alopecia
|
Phase 1 | |
Completed |
NCT06112782 -
Keravive by Hydrafacial for Scalp Health and Enhanced Hair Quality
|
N/A | |
Completed |
NCT02594046 -
The Effect of Allogeneic Human Adipose Derived Stem Cell Component Extract on Androgenic Alopecia
|
N/A | |
Recruiting |
NCT05435625 -
Fractional Laser Versus Radiofrequency in Androgenetic Alopecia
|
N/A | |
Completed |
NCT05450861 -
Effect of the Composition From Fish on Promoting Hair Growth
|
N/A | |
Completed |
NCT03506503 -
Condensed Nanofat Grafting for Treatment of Androgenetic Alopecia
|
N/A | |
Completed |
NCT03467412 -
To Investigate Efficacy of FOL-005 on Hair Growth on Scalp Skin
|
Phase 2 | |
Completed |
NCT01852487 -
Effect of Pumpkin Seed Oil on Hair Growth in Men With Androgenetic Alopecia
|
N/A | |
Not yet recruiting |
NCT03474718 -
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
|
Early Phase 1 | |
Active, not recruiting |
NCT02914587 -
Computer-Assisted Hair Implantation Using ARTAS System VS Manual Implantation Technique Hair Restoration Study
|
N/A | |
Completed |
NCT04341363 -
Follicular Revival in Androgenic Alopecia: Evaluating Use of Micro-needling
|
N/A | |
Completed |
NCT04450602 -
A Study Evaluating the Hair Regrowth Efficacy and Safety of ALRV5XR in Female Subjects With Hair Loss
|
N/A |