An interventional study of Low-Concentration CosmeRNA-ARI Anti Hair Loss Tonic and High-Concentration CosmeRNA-ARI Anti Hair Loss Tonic in Androgenetic Alopecia, sponsored by BIONEER Corporation. Completed at 1 site in South Korea. Open to participants aged 18 Years to 54 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by BIONEER Corporation · Not applicable, Interventional, and Other
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.
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.
511 studies on the registry are indexed under Alopecia; 128 are open to participants now.
This study's enrollment of 90 is above the median of 50 across 430 interventional studies indexed under Alopecia.
Browse Alopecia studies →BIONEER Corporation is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Low-Concentration CosmeRNA-ARI Anti Hair Loss Tonic
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.
Other: High-Concentration CosmeRNA-ARI Anti Hair Loss Tonic
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.
Other: Vehicle Control Tonic Without CosmeRNA-AR
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 8, Baseline to Week 16, and Baseline to Week 24
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.
Time frame: 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.
Time frame: Week 8, Week 16, and Week 24
Incidence of Scalp Adverse Reactions
Scalp adverse reactions were monitored throughout the study based on participant-reported symptoms, investigator examination, and adverse events observed or reported during product use. Investigator-assessed signs included erythema, edema, and papules. Participant-reported symptoms included itching, pricking pain, burning, tingling, and stiffness. The outcome was summarized as the number of participants with any scalp adverse reaction during product use.
Time frame: From baseline through Week 24
Product Use Compliance
Compliance was calculated as the percentage of required product applications that were completed during the 24-week study period. Participants with compliance below 80% were considered noncompliant according to the prespecified criterion.
Time frame: From first product application through Week 24
Participant-Reported Scalp Symptoms
Participants rated scalp scaling, scalp sebum, and dandruff severity using a 5-point scale ranging from 0, indicating none, to 4, indicating severe. Lower scores indicated fewer scalp symptoms. Results were summarized for each item in the low-concentration investigational product, high-concentration investigational product, and vehicle control groups.
Time frame: Baseline, Week 8, Week 16, and Week 24
Participant-Reported Product Acceptability
Participants evaluated product acceptability in terms of scalp moisturization, hair smoothness, spreadability, product scent, and overall user experience using a 5-point scale ranging from 0, indicating very poor, to 4, indicating very good. Results were summarized for each item in the low-concentration investigational product, high-concentration investigational product, and vehicle control groups.
Time frame: Week 24
Plan to share: No — There is no plan to share individual participant data.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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BIONEER Corporation