AGAPhase 3NCT05135468
A Phase 3 Clinical Study Patients With Androgenetic Alopecia (AGA)
A Phase 3 study testing CU-40102 Spray in people with AGA, run by Cutia Therapeutics（Wuxi）Co.,Ltd at 1 site in China.
Trial summary
A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Clinical Study ,the mean change from baseline in vertex target area hair count (TAHC) after treatment for 24 weeks. Read more about this study
- Who is it for?
- Ages 18 to 41 years, men only
- Conditions the study is for
- AGA
- What is being tested?
- CU-40102 Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 6 Dec 2021to 15 May 2023
- Phase
- Phase 3
- 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 41 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Having voluntarily signed the ICF approved by the Ethics Committee and consented to participate in this study before starting any study procedure;
- Being able to understand and comply with the requirements of the protocol and agreeing to participate in all study visits;
- Males aged 18 to 41 years (inclusive);
- Being diagnosed with Type III vertex, Type IV or Type V androgenetic alopecia (AGA) according to the Hamilton-Norwood classification (see Appendix 1 for details);
- Appropriate medical contraceptive methods being used to prevent the sexual partner from becoming pregnant from the time of signing ICF to 28 days after the last dose; -
Who cannot join
- A history of scalp skin abnormalities or scalp skin diseases at the time of screening
- Patients with secondary alopecia such as those associated with malnutrition, drugs, endocrine , iron deficiency anemia, or systemic lupus erythematosus;
- Patients with alopecia areata, alopecia cicatrisata, or trichotillomania;
- Having undergone hair transplantation or extension before screening, or persistent requirement to wear a wig sheath during study treatments;
- Known allergy to the active ingredient of the investigational drug or any component of the excipients, or to any component of the tattoo liquid;
- A history of depression, anxiety, personality disorder or other mental disorders;
- A history of varicocele or infertility ;
- A history of malignant tumor;
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People Hosptial
Beijing, Beijing Municipality, 100044
About this study
Official title: A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Finasteride Spray (CU-40102) in Chinese Adult Male Patients With Androgenetic Alopecia (AGA)
A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Clinical Study ,the mean change from baseline in vertex target area hair count (TAHC) after treatment for 24 weeks.
- Conditions
- AGA
- Being tested
- CU-40102 Spray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CU-40102 SprayDrug
topical application, 1~4 sprays each time, once daily
| Study group | Role | What they receive |
|---|---|---|
| CU-40102 Spray | Experimental | 0.25% (2.275mg/mL) Finasteride Receives: Drug: CU-40102 Spray |
| Placebo for CU-40102 Spray | Placebo comparator | Placebo Spray Receives: Drug: CU-40102 Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Rate of TAHC
the change from baseline in target area hair count (TAHC) in the vertex after treatment
Measured: 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start6 Dec 2021
- Primary completion7 Mar 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AGAStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Drug:0.25% (2.275mg/mL) Finasteride Spray Placebo for CU-40102 Spray
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutia Therapeutics（Wuxi）Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135468
- Sponsor's protocol ID
- CU-40102-303
- Status last verified
- Jul 2023
- First submitted
- 16 Nov 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou C, Yang B, Zeng H, Xia R, Dang N, Yang Q, Li J, Zhang C, Zhang G, Wei A, Lai W, Yang S, Diao Q, Ding Y, Wu L, Liu L, Jia D, Zhu H, Zhang J. Efficacy and safety of topical finasteride spray solution in the treatment of Chinese men with androgenetic alopecia: A phase III, multicenter, randomized, double-blind, placebo-controlled study. Chin Med J (Engl). 2026 Apr 5;139(7):1054-1061. doi: 10.1097/CM9.0000000000003495. Epub 2025 Mar 17.
PubMed 40090937
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Finasteride Spray (CU-40102) in Chinese Adult Male Patients With Androgenetic Alopecia (AGA)
- ClinicalTrials.gov ID
- NCT05135468
- Acronym / sponsor ID
- CU-40102-303
- Conditions
- AGA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Cutia Therapeutics（Wuxi）Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 26 Nov 2021 (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.
A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Clinical Study ,the mean change from baseline in vertex target area hair count (TAHC) after treatment for 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Drug:0.25% (2.275mg/mL) Finasteride Spray Placebo for CU-40102 Spray
| Arm | Type | Receives |
|---|---|---|
| CU-40102 Spray | Experimental | Drug: CU-40102 Spray0.25% (2.275mg/mL) Finasteride |
| Placebo for CU-40102 Spray | Placebo comparator | Drug: CU-40102 SprayPlacebo Spray |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Having voluntarily signed the ICF approved by the Ethics Committee and consented to participate in this study before starting any study procedure;
- Being able to understand and comply with the requirements of the protocol and agreeing to participate in all study visits;
- Males aged 18 to 41 years (inclusive);
- Being diagnosed with Type III vertex, Type IV or Type V androgenetic alopecia (AGA) according to the Hamilton-Norwood classification (see Appendix 1 for details);
- Appropriate medical contraceptive methods being used to prevent the sexual partner from becoming pregnant from the time of signing ICF to 28 days after the last dose; -
Key exclusion criteria (8 listed)
- A history of scalp skin abnormalities or scalp skin diseases at the time of screening
- Patients with secondary alopecia such as those associated with malnutrition, drugs, endocrine , iron deficiency anemia, or systemic lupus erythematosus;
- Patients with alopecia areata, alopecia cicatrisata, or trichotillomania;
- Having undergone hair transplantation or extension before screening, or persistent requirement to wear a wig sheath during study treatments;
- Known allergy to the active ingredient of the investigational drug or any component of the excipients, or to any component of the tattoo liquid;
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 |
|---|---|---|
| CU-40102 Spraytopical application, 1~4 sprays each time, once daily | Drug | CU-40102 Spray, Placebo for CU-40102 Spray |
Primary outcome
The Rate of TAHC
Time frame: 24 weeks.
the change from baseline in target area hair count (TAHC) in the vertex after treatment
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 1 Aug 2023.
- Derived from this study: PubMed 40090937Zhou C, Yang B, Zeng H, Xia R, Dang N, Yang Q, Li J, Zhang C, Zhang G, Wei A, Lai W, Yang S, Diao Q, Ding Y, Wu L, Liu L, Jia D, Zhu H, Zhang J. Efficacy and safety of topical finasteride spray solution in the treatment of Chinese men with androgenetic alopecia: A phase III, multicenter, randomized, double-blind, placebo-controlled study. Chin Med J (Engl). 2026 Apr 5;139(7):1054-1061. doi: 10.1097/CM9.0000000000003495. Epub 2025 Mar 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CU-40102 Spray in people with AGA, run by Cutia Therapeutics（Wuxi）Co.,Ltd at 1 site in China.
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 5 inclusion and 8 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 1 Aug 2023. 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 China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The Rate of TAHC (time frame: 24 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05135468, which also lists 1 linked publication.
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 1 Aug 2023.