Androgenic AlopeciaNCT03676400
Hair Growth Efficacy and Safety of NGF-574H in Adult With Androgenic Alopecia
A study testing conditioned media of umbilical cord blood-derived stem cells in people with Androgenic Alopecia, run by Medipost Co Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Androgenic Alopecia
- What is being tested?
- conditioned media of umbilical cord blood-derived stem cells
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Oct 2018to 24 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Androgenic Alopecia
- Being tested
- conditioned media of umbilical cord blood-derived stem cells, Placebo
- Keywords
- mesenchymal stem cells, conditioned media, NGF-574H, hair growth, androgenic alopecia, paracrine factors, umbilical cord blood
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conditioned media of umbilical cord blood-derived stem cellsOther
Also called NGF-574H
Hair serum with 5% conditioned media of human umbilical cord blood-derived mesenchymal stem cells
PlaceboOther
Hair serum without conditioned media of human umbilical cord blood-derived mesenchymal stem cells
| Study group | Role | What they receive |
|---|---|---|
| NGF-574H | Experimental | 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. Receives: Other: conditioned media of umbilical cord blood-derived stem cells |
| placebo | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 0, 6, 12 and 24 weeks
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)
Measured: 0, 6, 12 and 24 weeks
Secondary outcomes (4)
Change in mean Telogen hair density
Measurement of telogen hair density, in comparison to initial value (baseline) and/or placebo product.
Measured: 0, 6, 12 and 24 weeks
Change in mean Anagen hair density
Measurement of anagen hair density, in comparison to initial value (baseline) and/or placebo product.
Measured: 0, 6, 12 and 24 weeks
Change in hair growth speed
Measurement of hair growth speed, in comparison to initial value (baseline) and/or placebo product.
Measured: 0, 6, 12 and 24 weeks
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.
Measured: 0, 6, 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start2 Oct 2018
- Primary completion22 Jul 2019
- Study completion24 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Product group / Control(placebo) group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipost Co Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Byungcheol PARK, MD, Principal investigator, Dankook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676400
- Sponsor's protocol ID
- MP-CM-001
- Status last verified
- Aug 2019
- First submitted
- 12 Sep 2018
- Last updated
- 12 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03676400
- Acronym / sponsor ID
- MP-CM-001
- Conditions
- Androgenic Alopecia
- Keywords
- mesenchymal stem cells, conditioned media, NGF-574H, hair growth, androgenic alopecia, paracrine factors, umbilical cord blood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Medipost Co Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 22 Jul 2019 (actual)
- Study completion
- 24 Jul 2019 (actual)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Product group / Control(placebo) group
| Arm | Type | Receives |
|---|---|---|
| NGF-574H | Experimental | Other: conditioned media of umbilical cord blood-derived stem cellsNGF-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. |
| placebo | Placebo comparator | Other: PlaceboHair 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conditioned media of umbilical cord blood-derived stem cellsAlso: NGF-574HHair serum with 5% conditioned media of human umbilical cord blood-derived mesenchymal stem cells | Other | NGF-574H |
| PlaceboHair serum without conditioned media of human umbilical cord blood-derived mesenchymal stem cells | Other | placebo |
Primary outcome
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)
4 secondary outcomes
Change in mean Telogen hair density
Time frame: 0, 6, 12 and 24 weeks
Change in mean Anagen hair density
Time frame: 0, 6, 12 and 24 weeks
Change in hair growth speed
Time frame: 0, 6, 12 and 24 weeks
Change in hair diameter
Time frame: 0, 6, 12 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
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Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Byungcheol PARK, MD principal investigator
Dankook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conditioned media of umbilical cord blood-derived stem cells in people with Androgenic Alopecia, run by Medipost Co Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean total hair density (hair/cm2) (time frame: 0, 6, 12 and 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019.