Male Pattern of Hair Loss, Androgenic AlopeciaPhase 2NCT07076706
Clinical Trial to Evaluate CG2001 in Chinese Adult Male Participants With Androgenetic Alopecia
A Phase 2 study testing minoxidil + finasteride in people with Male Pattern of Hair Loss, Androgenic Alopecia and Androgenetic Alopecia (AGA), run by Beijing Dayspring Pharmaceutical Technology Co., Ltd at 8 sites in China.
Trial summary
The main objectives of this study are to preliminarily evaluate the effectiveness of CG2001 in treating Chinese adult male AGA participants, determine the recommended dose for Phase III clinical studies, and evaluate the safety of CG2001 at the target dose. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Male Pattern of Hair Loss, Androgenic Alopecia, Androgenetic Alopecia (AGA)
- What is being tested?
- minoxidil + finasteride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 8 sitesChina
- Study dates
- 5 Dec 2024to 23 Sep 2025
- Phase
- Phase 2
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who meet all of the following criteria can be included in this study:
- Voluntarily sign the Informed Consent Form (ICF) approved by the Ethics Committee (IEC) before any study procedures begin. Participant who can understand and comply with the requirements of the protocol and agree to participate in all study visits;
- Male participant, aged 18 to 65 years (including the critical value) when signing the ICF;
- Participant diagnosed with androgenic alopecia, manifested as frontal hairline recession or hair loss in the vertex scalp area, corresponding to the Hamilton-Norwood classification diagnosis of grade III vertex type (i.e. grade IIIv), grade IV and grade V;
- Willing and able to complete all study assessments and comply with the protocol study schedule and restrictions, such as the participant is willing to shave the target evaluation area during the study, be marked by the researcher and maintain the same hair color;
- Participant agrees to use appropriate medical contraceptive methods to avoid pregnancy in female partners from the signing of the ICF until 28 days after the last dose.
Who cannot join
- Before screening or administration, participants who meet any of the following criteria will not be included in this study:
- Allergic to any component of minoxidil, finasteride or excipients (such as a history of alcohol allergy), or allergic constitution;
- According to the researcher's judgment, the participant's head has any of the following conditions that may interfere with the study evaluation:
- History of scalp skin abnormalities or scalp skin diseases, such as obvious dermatitis, trauma or infection near the administration site; B. White hair in the hair loss area that obviously interferes with the study evaluation; C. Secondary hair loss, such as hair loss caused by malnutrition, drugs, endocrine (hypothyroidism or hyperthyroidism, parathyroid or pituitary dysfunction), iron deficiency anemia and systemic lupus erythematosus; D. Hair loss caused by other reasons other than androgenic alopecia, such as alopecia areata, scarring alopecia, trichotillomania, telogen effluvium, or sudden increase in hair loss within 3 months before screening;
- Regarding the history of previous treatment, any of the following conditions may interfere with the study evaluation:
- Use of oral finasteride, dutasteride or similar products for androgenic alopecia within 1 year before screening; B. Use of topical minoxidil, local scalp radiation, phototherapy/laser or local injection of autologous platelet-rich plasma (PRP) within 6 months before screening; C. Underwent general anesthesia within 3 months before screening; D. Use of systemic or topical scalp corticosteroids or synthetic steroids, or other drugs that affect androgenic alopecia within 4 weeks before screening or within 5 half-lives of the drug used (whichever is longer); E. Use of medical shampoos or solutions containing other ingredients such as ketoconazole or similar ingredients that may interfere with efficacy evaluation within 1 week before the first medication; F. Participants who have had hair transplantation, hair extensions or hair weaving before screening; or plan to have hair transplantation, hair extensions or hair weaving during the study treatment; or need to wear a wig for a long time; G. Participants who plan to use treatments related to hair growth and may affect prolactin levels; H. Participants who have used minoxidil regularly for ≥4 months but have not been effective; I. Participants who have received CG2001 treatment before.
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- Other diseases with poorly controlled conditions that may affect the safety and efficacy evaluation of the trial drugs, such as malignant tumors, or poorly controlled diseases in the circulatory system, nervous system, blood system, digestive system (such as inflammatory bowel disease), immune system, mental system, etc. (except for completely resected carcinoma in situ, localized prostate cancer that has received radical treatment and has no disease recurrence, completely resected basal cell or squamous cell skin cancer, malignant melanoma with a complete remission time of more than 10 years, and other malignant tumors with a complete remission time of more than 5 years); or participants who plan to undergo surgery during the study; or within 3 months before screening, the weight loss exceeds 10% of their original body weight;
- Physical examination, vital signs, 12-lead electrocardiogram (ECG), blood routine, urine routine, blood biochemistry, and sex hormone test results during the screening period are abnormal and clinically significant (especially for participants with anemia), and the researchers judge that it will affect the safety assessment;
- History of drug abuse, alcoholism or drug abuse within 5 years before screening (Note: alcoholism includes binge drinking and heavy drinking. Binge drinking means that men drink 5 or more alcoholic drinks in about 2 hours at a time; heavy drinking or harmful drinking means that men drink 4 or more alcoholic drinks on any day, or the average daily alcohol intake of male drinkers is ≥61g; "cup" here means "standard cup", that is, 1 standard cup equals 10 grams of pure alcohol, 1 bottle of 750 ml wine is equivalent to 9 standard cups, 1 bottle of beer is equivalent to 2 standard cups, 1 bottle of 500 ml yellow wine (rice wine) is equivalent to 6 standard cups, 1 liang of 52-degree liquor is equivalent to 2 standard cups, 1 liang of 45-degree liquor is equivalent to 1.8 standard cups, 1 liang of 38-degree liquor is equivalent to 1.5 standard cups, and the number of grams of alcohol intake is equal to the number of milliliters of alcohol consumed × alcohol content × 0.8);
- Participated in or is participating in other interventional clinical trials (including drugs and medical devices) within 1 month before screening;
- The researcher believes that there are any other reasons that make the participants unsuitable for participation in this study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality
China-Japan Friendship Hospital
Beijing, Beijing Municipality
Peking University People's Hospital
Beijing
Xiangya Hospital of Central South University
Changsha, Hunan
Hangzhou First People's Hospital
Hangzhou, Zhejiang
Jiangxi Provincial Dermatology Hospital
Nanchang, Jiangxi
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of CG2001 in Chinese Adult Male Participants With Androgenetic Alopecia
The main objectives of this study are to preliminarily evaluate the effectiveness of CG2001 in treating Chinese adult male AGA participants, determine the recommended dose for Phase III clinical studies, and evaluate the safety of CG2001 at the target dose.
- Being tested
- minoxidil + finasteride, Placebo foam
- Keywords
- minoxidil, finasteride
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minoxidil + finasterideDrug
topical foam: 5%minoxidil+0.075%finasteride
minoxidil + finasterideDrug
topical foam: 5%minoxidil+0.1%finasteride
Placebo foamDrug
Topical placebo foam
| Study group | Role | What they receive |
|---|---|---|
| Minoxidil and low dose finasteride or placebo | Experimental | CG2001(5%minoxidil+0.075%finasteride) or placebo twice daily Receives: Drug: minoxidil + finasteride; Drug: Placebo foam |
| Minoxidil and high dose finasteride or placebo | Experimental | CG2001(5%minoxidil+0.1%finasteride) or placebo twice daily Receives: Drug: minoxidil + finasteride; Drug: Placebo foam |
| Minoxidil and low dose finasteride | Experimental | CG2001(5%minoxidil+0..075%finasteride) twice daily Receives: Drug: minoxidil + finasteride |
| Placebo | Placebo comparator | placebo Receives: Drug: Placebo foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the non-vellus target area hair count(TAHC) at 24 weeks
Measured: 24 weeks
Secondary outcomes (7)
Hair Growth Questionnaire
Questionnaire assessing hair condition by participant. The score ranges from 7 to 38, higher scores mean a worse outcome.
Measured: 6, 12, 18, 24 weeks
Participant self assessment of treatment satisfaction
Treatment satisfaction will be measured with the "Patient Treatment-Effect Satisfaction Evaluation Form", a single-item, self-administered questionnaire with the score ranges from -3 to +3, where a higher score mean a highr satisfaction.
Measured: 6, ,12, 18, 24 weeks
Investigator Global Assessment(IGA)
Assessment made by investigator about the global condition of participant's hair. The value ranges from 0 to 4, higher score means a worse outcome.
Measured: 6, 12, 18, 24 weeks
Change from baseline in non-vellus target area hair count(TAHC)
Measured: 6, 12, 18 weeks
Change from baseline in Target Area Hair Width(TAHW)
Target Area Hair Width (TAHW) is the cumulative hair diameter per unit area in the target area
Measured: 6, 12, 18, 24 weeks
Change from baseline in terminal-vellus ratio
Measured: 6, 12, 18, 24 weeks
Adverse events
Measured: up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start5 Dec 2024
- Primary completion26 Aug 2025
- Study completion23 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male Pattern of Hair Loss, 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Dayspring Pharmaceutical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianzhong Zhang, MD, PhD, Study chair, Peking University People's HospitalCheng Zhou, MD, PhD, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076706
- Sponsor's protocol ID
- CG2001-C-2
- Status last verified
- Mar 2026
- First submitted
- 1 Jul 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of CG2001 in Chinese Adult Male Participants With Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT07076706
- Acronym / sponsor ID
- CG2001-C-2
- Keywords
- minoxidil, finasteride
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Beijing Dayspring Pharmaceutical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 26 Aug 2025 (actual)
- Study completion
- 23 Sep 2025 (actual)
- First posted
- 22 Jul 2025 (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 main objectives of this study are to preliminarily evaluate the effectiveness of CG2001 in treating Chinese adult male AGA participants, determine the recommended dose for Phase III clinical studies, and evaluate the safety of CG2001 at the target dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Minoxidil and low dose finasteride or placebo | Experimental | Drug: minoxidil + finasteride, Drug: Placebo foamCG2001(5%minoxidil+0.075%finasteride) or placebo twice daily |
| Minoxidil and high dose finasteride or placebo | Experimental | Drug: minoxidil + finasteride, Drug: Placebo foamCG2001(5%minoxidil+0.1%finasteride) or placebo twice daily |
| Minoxidil and low dose finasteride | Experimental | Drug: minoxidil + finasterideCG2001(5%minoxidil+0..075%finasteride) twice daily |
| Placebo | Placebo comparator | Drug: Placebo foamplacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntarily sign the Informed Consent Form (ICF) approved by the Ethics Committee (IEC) before any study procedures begin. Participant who can understand and comply with the requirements of the protocol and agree to participate in all study visits;
- Male participant, aged 18 to 65 years (including the critical value) when signing the ICF;
- Participant diagnosed with androgenic alopecia, manifested as frontal hairline recession or hair loss in the vertex scalp area, corresponding to the Hamilton-Norwood classification diagnosis of grade III vertex type (i.e. grade IIIv), grade IV and grade V;
- Willing and able to complete all study assessments and comply with the protocol study schedule and restrictions, such as the participant is willing to shave the target evaluation area during the study, be marked by the researcher and maintain the same hair color;
- Participant agrees to use appropriate medical contraceptive methods to avoid pregnancy in female partners from the signing of the ICF until 28 days after the last dose.
Key exclusion criteria (11 listed)
- Before screening or administration, participants who meet any of the following criteria will not be included in this study:
- Allergic to any component of minoxidil, finasteride or excipients (such as a history of alcohol allergy), or allergic constitution;
- According to the researcher's judgment, the participant's head has any of the following conditions that may interfere with the study evaluation:
- Regarding the history of previous treatment, any of the following conditions may interfere with the study evaluation:
- Other diseases with poorly controlled conditions that may affect the safety and efficacy evaluation of the trial drugs, such as malignant tumors, or poorly controlled diseases in the circulatory system, nervous system, blood system, digestive system (such as inflammatory bowel disease), immune system, mental system, etc. (except for completely resected carcinoma in situ, localized prostate cancer that has received radical treatment and has no disease recurrence, completely resected basal cell or squamous cell skin cancer, malignant melanoma with a complete remission time of more than 10 years, and other malignant tumors with a complete remission time of more than 5 years); or participants who plan to undergo surgery during the study; or within 3 months before screening, the weight loss exceeds 10% of their original body weight;
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 |
|---|---|---|
| minoxidil + finasteridetopical foam: 5%minoxidil+0.075%finasteride | Drug | Minoxidil and low dose finasteride, Minoxidil and low dose finasteride or placebo |
| minoxidil + finasteridetopical foam: 5%minoxidil+0.1%finasteride | Drug | Minoxidil and high dose finasteride or placebo |
| Placebo foamTopical placebo foam | Drug | Minoxidil and high dose finasteride or placebo, Minoxidil and low dose finasteride or placebo, Placebo |
Primary outcome
Change from baseline in the non-vellus target area hair count(TAHC) at 24 weeks
Time frame: 24 weeks
7 secondary outcomes
Hair Growth Questionnaire
Time frame: 6, 12, 18, 24 weeks
Participant self assessment of treatment satisfaction
Time frame: 6, ,12, 18, 24 weeks
Investigator Global Assessment(IGA)
Time frame: 6, 12, 18, 24 weeks
Change from baseline in non-vellus target area hair count(TAHC)
Time frame: 6, 12, 18 weeks
Change from baseline in Target Area Hair Width(TAHW)
Time frame: 6, 12, 18, 24 weeks
Change from baseline in terminal-vellus ratio
Time frame: 6, 12, 18, 24 weeks
Adverse events
Time frame: up to 28 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 3 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Jianzhong Zhang, MD, PhD study chair
Peking University People's Hospital
Cheng Zhou, MD, PhD study chair
Peking University People's Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing minoxidil + finasteride in people with Male Pattern of Hair Loss, Androgenic Alopecia and Androgenetic Alopecia (AGA), run by Beijing Dayspring Pharmaceutical Technology Co., Ltd at 8 sites 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 6 inclusion and 11 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 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from baseline in the non-vellus target area hair count(TAHC) at 24 weeks (time frame: 24 weeks). 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 3 Mar 2026.