Androgenetic AlopeciaNCT07898566
Efficacy and Safety of CosmeRNA-ARI Anti Hair Loss Tonic in Adults With Androgenetic Alopecia
A study testing Low-Concentration CosmeRNA-ARI Anti Hair Loss Tonic and High-Concentration CosmeRNA-ARI Anti Hair Loss Tonic in people with Androgenetic Alopecia, run by BIONEER Corporation at 1 site in South Korea.
Trial summary
This study evaluated the efficacy and safety of two concentrations of CosmeRNA-ARI Anti Hair Loss Tonic in adults with androgenetic alopecia. Participants were randomly assigned to receive the low-concentration investigational product, the high-concentration investigational product, or a vehicle control product… Read more about this study
- Who is it for?
- Ages 18 to 54 years
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Low-Concentration CosmeRNA-ARI Anti Hair Loss Tonic and High-Concentration CosmeRNA-ARI Anti Hair Loss Tonic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Dec 2024to 22 Jan 2026
- 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 54 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female adults aged 18 to 54 years with androgenetic alopecia diagnosed according to at least one of the following applicable classification systems:
- Basic and Specific classification: basic type M1 or higher, C1 or higher, or U1 or higher, together with specific type V1 or higher or F1 or higher
- Norwood-Hamilton classification: stage II or higher for male participants
- Ludwig classification: stage I or higher for female participants
- Participants willing to avoid special hair products, hair treatments, and other manipulation of the hair during the study period
- Participants willing to maintain the same hairstyle and hair color as at the first study visit throughout the study period
- Participants who understood the purpose of the study and voluntarily provided written informed consent
Who cannot join
- Serious acute renal or cardiac disease, or another chronic disease such as hypertension or diabetes, within the previous 6 months that could affect the study results
- Pregnancy, breastfeeding, or plans to become pregnant within 6 months
- Psychiatric disease
- Infectious skin disease
- Previous surgical treatment for hair loss, including hair transplantation or scalp reduction surgery
- Use of oral dutasteride or finasteride within the previous 6 months
Show all 13Show fewer
- Use of topical hair growth products, hair tonics, or other products intended to promote hair growth within the previous month
- Use within the previous month of steroids, cytotoxic agents, vasodilators, antihypertensive agents, anticonvulsants, beta-blockers, bronchodilators, diuretics, spironolactone, cimetidine, diazoxide, cyclosporine, or ketoconazole
- Use of a topical corticosteroid on the scalp within the previous month
- Severe seborrheic dermatitis, scalp psoriasis, scalp infection, or another scalp condition considered likely to interfere with application of the study product
- A hair loss disorder other than androgenetic alopecia, including alopecia areata, telogen effluvium, or scarring alopecia
- Nutritional deficiency caused by excessive dietary restriction, gastrectomy, or another condition, or use of nutritional supplements that could affect hair loss
- Any other condition considered by the principal investigator to make the individual unsuitable for study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 24-Week, Double-Blind, Placebo-Controlled, Randomized Human Application Study to Evaluate the Efficacy and Safety of CosmeRNA-ARI Anti Hair Loss Tonic in Adults With Androgenetic Alopecia
This study evaluated the efficacy and safety of two concentrations of CosmeRNA-ARI Anti Hair Loss Tonic in adults with androgenetic alopecia. Participants were randomly assigned to receive the low-concentration investigational product, the high-concentration investigational product, or a vehicle control product without the active ingredient. Each assigned product was applied to the scalp once every 2 weeks for 24 weeks. Hair density, hair thickness, hair growth rate, expert-assessed changes in hair density, participant-reported outcomes, and scalp safety were evaluated. The study was designed to determine whether the investigational products improved hair growth-related outcomes compared with the vehicle control product.
Read the detailed description
This was a 24-week, randomized, double-blind, vehicle-controlled, parallel-group human application study conducted in Korean adults aged 18 to 54 years with androgenetic alopecia. Eligible participants were diagnosed according to the Basic and Specific classification, the Norwood-Hamilton classification, or the Ludwig classification, as applicable.
After a 2-week washout period, participants were randomly assigned in a 1:1:1 ratio to one of three groups: a low-concentration CosmeRNA-ARI Anti Hair Loss Tonic group, a high-concentration CosmeRNA-ARI Anti Hair Loss Tonic group, or a vehicle control group formulated without the active ingredient. The assigned product was applied to the scalp by study personnel once every 2 weeks for 24 weeks, for a total of 12 applications. Participants and investigators remained masked to product assignment until completion of the study.
Instrumental assessments were performed using Folliscope 5.0. Hair density was determined as the number of hairs per square centimeter in a designated scalp area. Hair thickness and hair growth rate were measured from selected hairs within the same assessment area. Measurements were performed at baseline and after 8, 16, and 24 weeks of product use. Hair growth rate was determined using images obtained 2 days after each scheduled measurement.
Standardized photographs of the vertex and frontal hairline were obtained at baseline and after 8, 16, and 24 weeks. Two experts independently evaluated changes in hair appearance using a 7-point scale ranging from -3, indicating markedly worse, to +3, indicating markedly improved. Inter-rater reliability was assessed using the intraclass correlation coefficient.
Participants also evaluated perceived changes in hair loss symptoms, hair fullness at the vertex, the amount of shed hair, and the frontal hairline. Scalp safety was monitored throughout the study based on participant-reported symptoms, investigator examination, and adverse events observed or reported during product use.
- Conditions
- Androgenetic Alopecia
- Being tested
- Low-Concentration CosmeRNA-ARI Anti Hair Loss Tonic, High-Concentration CosmeRNA-ARI Anti Hair Loss Tonic, Vehicle Control Tonic Without CosmeRNA-AR
- Keywords
- Hair Density, Hair Thickness, Hair Growth Rate, Hair Growth, Pattern Hair Loss, Scalp Tonic, Cosmetic Product, Human Application Study
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Concentration CosmeRNA-ARI Anti Hair Loss TonicOther
A transparent liquid cosmetic scalp formulation containing CosmeRNA-AR at the lower concentration evaluated in this study. The product was applied topically to the scalp by study personnel once every 2 weeks for 24 weeks, for a total of 12 applications.
High-Concentration CosmeRNA-ARI Anti Hair Loss TonicOther
A transparent liquid cosmetic scalp formulation containing CosmeRNA-AR at the higher concentration evaluated in this study. The product was applied topically to the scalp by study personnel once every 2 weeks for 24 weeks, for a total of 12 applications.
Vehicle Control Tonic Without CosmeRNA-AROther
A transparent liquid cosmetic scalp formulation without CosmeRNA-AR. The control product was applied using the same method and schedule as the investigational products: once every 2 weeks for 24 weeks, for a total of 12 applications.
| Study group | Role | What they receive |
|---|---|---|
| Low-Concentration CosmeRNA-ARI Anti Hair Loss Tonic | Experimental | Participants assigned to this arm received the low-concentration CosmeRNA-ARI Anti Hair Loss Tonic applied topically to the scalp by study personnel once every 2 weeks for 24 weeks, for a total of 12 applications. Receives: Other: Low-Concentration CosmeRNA-ARI Anti Hair Loss Tonic |
| High-Concentration CosmeRNA-ARI Anti Hair Loss Tonic | Experimental | Participants assigned to this arm received the high-concentration CosmeRNA-ARI Anti Hair Loss Tonic applied topically to the scalp by study personnel once every 2 weeks for 24 weeks, for a total of 12 applications. Receives: Other: High-Concentration CosmeRNA-ARI Anti Hair Loss Tonic |
| Vehicle Control | Placebo comparator | Participants assigned to this arm received the vehicle control product formulated without CosmeRNA-AR. The control product was applied topically to the scalp by study personnel once every 2 weeks for 24 weeks, for a total of 12 applications. Receives: Other: Vehicle Control Tonic Without CosmeRNA-AR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Hair Density
Hair density was measured as the number of hairs per square centimeter in a designated scalp area using Folliscope 5.0. The same marked scalp area was assessed at baseline and after 8, 16, and 24 weeks of product use. Changes from baseline were compared among the low-concentration investigational product, high-concentration investigational product, and vehicle control groups.
Measured: Baseline to Week 8, Baseline to Week 16, and Baseline to Week 24
Change From Baseline in Hair Thickness
Hair thickness was measured in millimeters using Folliscope 5.0. Three hairs within the designated scalp assessment area were selected for analysis. The same marked scalp area was assessed at baseline and after 8, 16, and 24 weeks of product use. Higher values indicated thicker hair. Changes from baseline were compared among the three study groups.
Measured: Baseline to Week 8, Baseline to Week 16, and Baseline to Week 24
Change From Baseline in Hair Growth Rate
Hair growth rate was measured in millimeters per day using Folliscope 5.0. Three hairs within the designated scalp assessment area were selected for analysis. At baseline and after 8, 16, and 24 weeks of product use, paired images were obtained 2 days apart to calculate the daily hair growth rate. Higher values indicated faster hair growth. Changes from baseline were compared among the three study groups.
Measured: Baseline to Week 8, Baseline to Week 16, and Baseline to Week 24
Secondary outcomes (2)
Expert Global Assessment of Hair Growth
Standardized photographs of the vertex and frontal hairline were independently evaluated by two experts using a 7-point global photographic assessment scale ranging from -3, indicating markedly worse, to +3, indicating markedly improved; 0 indicated no change from baseline. If the two experts assigned different scores, the lower score was used for analysis. Inter-rater reliability was evaluated using the intraclass correlation coefficient. Scores were compared among the low-concentration investigational product, high-concentration investigational product, and vehicle control groups.
Measured: Week 8, Week 16, and Week 24
Participant-Reported Evaluation of Changes in Hair Loss Symptoms
Participants evaluated perceived changes in overall hair loss symptoms, hair fullness at the vertex, the amount of shed hair, and the frontal hairline using a 7-point scale ranging from -3, indicating markedly worse, to +3, indicating markedly improved; 0 indicated no change. Responses of +1 to +3 were classified as positive responses. Results were summarized as the percentage of participants providing a positive response to each item.
Measured: Week 8, Week 16, and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start16 Dec 2024
- Primary completion22 Jan 2026
- Study completion22 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1:1 ratio to one of three parallel groups: a low-concentration CosmeRNA-ARI Anti Hair Loss Tonic group, a high-concentration CosmeRNA-ARI Anti Hair Loss Tonic group, or a vehicle control group without the active ingredient. Each participant received the assigned product once every 2 weeks for 24 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- BIONEER Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hae Kwang Lee, PhD, Principal investigator, P&K Skin Research Center Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898566
- Sponsor's protocol ID
- PNK-24D16-H1R1
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-Week, Double-Blind, Placebo-Controlled, Randomized Human Application Study to Evaluate the Efficacy and Safety of CosmeRNA-ARI Anti Hair Loss Tonic in Adults With Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT07898566
- Acronym / sponsor ID
- PNK-24D16-H1R1
- Conditions
- Androgenetic Alopecia
- Keywords
- Hair Density, Hair Thickness, Hair Growth Rate, Hair Growth, Pattern Hair Loss, Scalp Tonic, Cosmetic Product, Human Application Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- BIONEER CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 22 Jan 2026 (actual)
- Study completion
- 22 Jan 2026 (actual)
- First posted
- 27 Oct 2026 (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.
This study evaluated the efficacy and safety of two concentrations of CosmeRNA-ARI Anti Hair Loss Tonic in adults with androgenetic alopecia. Participants were randomly assigned to receive the low-concentration investigational product, the high-concentration investigational product, or a vehicle control product without the active ingredient. Each assigned product was applied to the scalp once every 2 weeks for 24 weeks. Hair density, hair thickness, hair growth rate, expert-assessed changes in hair density, participant-reported outcomes, and scalp safety were evaluated. The study was designed to determine whether the investigational products improved hair growth-related outcomes compared with the vehicle control product.
Detailed description
This was a 24-week, randomized, double-blind, vehicle-controlled, parallel-group human application study conducted in Korean adults aged 18 to 54 years with androgenetic alopecia. Eligible participants were diagnosed according to the Basic and Specific classification, the Norwood-Hamilton classification, or the Ludwig classification, as applicable.
After a 2-week washout period, participants were randomly assigned in a 1:1:1 ratio to one of three groups: a low-concentration CosmeRNA-ARI Anti Hair Loss Tonic group, a high-concentration CosmeRNA-ARI Anti Hair Loss Tonic group, or a vehicle control group formulated without the active ingredient. The assigned product was applied to the scalp by study personnel once every 2 weeks for 24 weeks, for a total of 12 applications. Participants and investigators remained masked to product assignment until completion of the study.
Instrumental assessments were performed using Folliscope 5.0. Hair density was determined as the number of hairs per square centimeter in a designated scalp area. Hair thickness and hair growth rate were measured from selected hairs within the same assessment area. Measurements were performed at baseline and after 8, 16, and 24 weeks of product use. Hair growth rate was determined using images obtained 2 days after each scheduled measurement.
Standardized photographs of the vertex and frontal hairline were obtained at baseline and after 8, 16, and 24 weeks. Two experts independently evaluated changes in hair appearance using a 7-point scale ranging from -3, indicating markedly worse, to +3, indicating markedly improved. Inter-rater reliability was assessed using the intraclass correlation coefficient.
Participants also evaluated perceived changes in hair loss symptoms, hair fullness at the vertex, the amount of shed hair, and the frontal hairline. Scalp safety was monitored throughout the study based on participant-reported symptoms, investigator examination, and adverse events observed or reported during product use.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Participants were randomly assigned in a 1:1:1 ratio to one of three parallel groups: a low-concentration CosmeRNA-ARI Anti Hair Loss Tonic group, a high-concentration CosmeRNA-ARI Anti Hair Loss Tonic group, or a vehicle control group without the active ingredient. Each participant received the assigned product once every 2 weeks for 24 weeks.
| Arm | Type | Receives |
|---|---|---|
| Low-Concentration CosmeRNA-ARI Anti Hair Loss Tonic | Experimental | Other: Low-Concentration CosmeRNA-ARI Anti Hair Loss TonicParticipants assigned to this arm received the low-concentration CosmeRNA-ARI Anti Hair Loss Tonic applied topically to the scalp by study personnel once every 2 weeks for 24 weeks, for a total of 12 applications. |
| High-Concentration CosmeRNA-ARI Anti Hair Loss Tonic | Experimental | Other: High-Concentration CosmeRNA-ARI Anti Hair Loss TonicParticipants assigned to this arm received the high-concentration CosmeRNA-ARI Anti Hair Loss Tonic applied topically to the scalp by study personnel once every 2 weeks for 24 weeks, for a total of 12 applications. |
| Vehicle Control | Placebo comparator | Other: Vehicle Control Tonic Without CosmeRNA-ARParticipants assigned to this arm received the vehicle control product formulated without CosmeRNA-AR. The control product was applied topically to the scalp by study personnel once every 2 weeks for 24 weeks, for a total of 12 applications. |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female adults aged 18 to 54 years with androgenetic alopecia diagnosed according to at least one of the following applicable classification systems:
- Basic and Specific classification: basic type M1 or higher, C1 or higher, or U1 or higher, together with specific type V1 or higher or F1 or higher
- Norwood-Hamilton classification: stage II or higher for male participants
- Ludwig classification: stage I or higher for female participants
- Participants willing to avoid special hair products, hair treatments, and other manipulation of the hair during the study period
Key exclusion criteria (13 listed)
- Serious acute renal or cardiac disease, or another chronic disease such as hypertension or diabetes, within the previous 6 months that could affect the study results
- Pregnancy, breastfeeding, or plans to become pregnant within 6 months
- Psychiatric disease
- Infectious skin disease
- Previous surgical treatment for hair loss, including hair transplantation or scalp reduction surgery
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 |
|---|---|---|
| Low-Concentration CosmeRNA-ARI Anti Hair Loss TonicA transparent liquid cosmetic scalp formulation containing CosmeRNA-AR at the lower concentration evaluated in this study. The product was applied topically to the scalp by study personnel once every 2 weeks for 24 weeks, for a total of 12 applications. | Other | Low-Concentration CosmeRNA-ARI Anti Hair Loss Tonic |
| High-Concentration CosmeRNA-ARI Anti Hair Loss TonicA transparent liquid cosmetic scalp formulation containing CosmeRNA-AR at the higher concentration evaluated in this study. The product was applied topically to the scalp by study personnel once every 2 weeks for 24 weeks, for a total of 12 applications. | Other | High-Concentration CosmeRNA-ARI Anti Hair Loss Tonic |
| Vehicle Control Tonic Without CosmeRNA-ARA transparent liquid cosmetic scalp formulation without CosmeRNA-AR. The control product was applied using the same method and schedule as the investigational products: once every 2 weeks for 24 weeks, for a total of 12 applications. | Other | Vehicle Control |
Primary outcome
Change From Baseline in Hair Density
Time frame: Baseline to Week 8, Baseline to Week 16, and Baseline to Week 24
Hair density was measured as the number of hairs per square centimeter in a designated scalp area using Folliscope 5.0. The same marked scalp area was assessed at baseline and after 8, 16, and 24 weeks of product use. Changes from baseline were compared among the low-concentration investigational product, high-concentration investigational product, and vehicle control groups.
Change From Baseline in Hair Thickness
Time frame: Baseline to Week 8, Baseline to Week 16, and Baseline to Week 24
Hair thickness was measured in millimeters using Folliscope 5.0. Three hairs within the designated scalp assessment area were selected for analysis. The same marked scalp area was assessed at baseline and after 8, 16, and 24 weeks of product use. Higher values indicated thicker hair. Changes from baseline were compared among the three study groups.
Change From Baseline in Hair Growth Rate
Time frame: Baseline to Week 8, Baseline to Week 16, and Baseline to Week 24
Hair growth rate was measured in millimeters per day using Folliscope 5.0. Three hairs within the designated scalp assessment area were selected for analysis. At baseline and after 8, 16, and 24 weeks of product use, paired images were obtained 2 days apart to calculate the daily hair growth rate. Higher values indicated faster hair growth. Changes from baseline were compared among the three study groups.
2 secondary outcomes
Expert Global Assessment of Hair Growth
Time frame: Week 8, Week 16, and Week 24
Participant-Reported Evaluation of Changes in Hair Loss Symptoms
Time frame: Week 8, Week 16, and Week 24
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 27 Oct 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data.
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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.
Hae Kwang Lee, PhD principal investigator
P&K Skin Research Center Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Concentration CosmeRNA-ARI Anti Hair Loss Tonic and High-Concentration CosmeRNA-ARI Anti Hair Loss Tonic in people with Androgenetic Alopecia, run by BIONEER Corporation 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 7 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 27 Oct 2026. 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 From Baseline in Hair Density (time frame: Baseline to Week 8, Baseline to Week 16, and Baseline to Week 24). The study lists 3 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 27 Oct 2026.