Androgenetic AlopeciaPhase 3NCT06126965
Phase III Study of KX-826 With Adult Male Patients With AGA
A Phase 3 study testing KX-826-（5%） BID in people with Androgenetic Alopecia, run by Suzhou Kintor Pharmaceutical Inc, at 26 sites in China.
Trial summary
This is a phase III, multi-center, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of KX-826 for topical use in Chinese adult male patients with androgenetic alopecia (AGA). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- KX-826-（5%） BID
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 740 participants
- Where
- 26 sitesChina
- Study dates
- 29 Dec 2021to 31 May 2024
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Agree to follow the study treatment regimen and visit plan, voluntarily enroll in the study, and sign the ICF in writing;
- Male, ≥ 18 old;
- Clinically diagnosed as androgenetic alopecia;
- Rating IIIv, IV and V on Hamilton-Norwood scale;
Who cannot join
- Have used androgen replacement therapy, immunosuppressants, corticosteroids and other drugs that may affect the efficacy evaluation within 3 months prior to screening;
- Have used minoxidil within 6 months prior to screening;
- Have used finasteride or dutasteride within 12 months prior to screening;
- Had used topical drugs for alopecia sites within 3 months prior to screening;
- Have received scalp radiation and/or laser or surgical therapy within 12 months prior to screening;
- Those who, in the opinion of the investigator, have other conditions that may affect compliance or are not suitable for participation in this study.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
China26 sites
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality
Beijing Tongren Hospital,Cmu
Beijing, Beijing Municipality
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality
China-Japan Friendship Hospital
Beijing, Beijing Municipality
Peking University First Hospital
Beijing, Beijing Municipality
Peking University People's Hospital
Beijing, Beijing Municipality
The Second Xiangya Hospital Of Central South University
Changsha, Hunan
Xiangya Hospital Central South University
Changsha, Hunan
West China Hospital Sichuan University
Chengdou, Sichuan
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Affiliated Hangzhou First People's Hospital,Zhejiang University School Of Medicine
Hangzhou, Zhejiang
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
The Second Hospital Of Anhui Medical University
Hefei, Anhui
Huashan Hospital
Shanghai, Shanghai Municipality
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality
The First Hospital Of China Medical University
Shenyang, Liaoning
Shenzhen People's Hospital
Shenzhen, Guangdong
The First Hospital Of Hebei Medical University
Shijiazhuang, Hebei
Tianjin Academy Of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Wuhan Hospital Of Traditional Chinese And Western Medicine
Wuhan, Hubei
Sir Run Run Shaw Hospital,ZheJiang University School Of Medicine
Zhejiang, Hangzhou
The First Affiliated Hospital Of Zhengzhou University
Zhengzhou, Henan
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu
About this study
Official title: A Phase III, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of KX-826 for Topical Use in Chinese Adult Male Patients With Androgenetic Alopecia (AGA)
This is a phase III, multi-center, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of KX-826 for topical use in Chinese adult male patients with androgenetic alopecia (AGA).
Read the detailed description
In this study, around 740 adult male subjects with AGA (rating IIIv, IV and V on Hamilton-Norwood scale) were to be enrolled. All subjects would be evaluated with 1:1 randomized to receive active drug or placebo in a double-blind fashion (370 subjects in each group), and would be treated for 24 weeks at the specified dose and frequency of each group. During the study, the subjects would undergo periodic efficacy and safety-related examinations and evaluation.
- Conditions
- Androgenetic Alopecia
- Being tested
- KX-826-（5%） BID, Placebo
- Keywords
- KX-826, AGA
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KX-826-（5%） BIDDrug
Also called KX-826-5 mg(5%)60mL BID
Dosage and administration: Topical application, 7 sprays (approximately 1 ml)/time, in the target area of the scalp, starting from the center of the affected area and massaging with hands until absorption. It should be used when the hair and scalp are completely dry. Wash hands after use. The randomized active drug would be administered to the scalp once in the morning and once in the evening.
PlaceboOther
Dosage and administration: Topical application, 7 sprays (approximately 1 ml)/time, in the target area of the scalp, starting from the center of the affected area and massaging with hands until absorption. It should be used when the hair and scalp are completely dry. Wash hands after use. The randomized matching placebo would be administered to the scalp once in the morning and once in the evening.
| Study group | Role | What they receive |
|---|---|---|
| KX-826-0.5% BID | Experimental | treatment dose group of 0.5% BID(0.5%) Receives: Drug: KX-826-（5%） BID |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24 in comparison to placebo).
change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24 in comparison to placebo).
Measured: mean change from baseline after 24 weeks of treatment
Secondary outcomes (2)
Secondary Outcome Measure:
Hair growth assessment (HGA) of patient self-assessment, and Hair growth assessment (HGA) of investigator assessment
Measured: change from baseline after 6, 12, 18, and 24 weeks of treatment, assessed using a 7-category method
Change in non-vellus hair diameter (width) in the target area (TAHW) (change from baseline at Weeks 6, 12, 18, 24 of treatment)
Change in non-vellus hair diameter (width) in the target area (TAHW) (change from baseline at Weeks 6, 12, 18, 24 of treatment)
Measured: change from baseline after 6, 12, 18, and 24 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start29 Dec 2021
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 740 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Kintor Pharmaceutical Inc,
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Suzhou Koshine Biomedica, Inc.
- Responsible party
- Sponsor
- Investigators
- Jianzhong Zhang, Principal investigator, Peking University People's HospitalQinping Yang, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126965
- Sponsor's protocol ID
- KX0826-CN-1003
- Status last verified
- Nov 2023
- First submitted
- 29 Oct 2023
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of KX-826 for Topical Use in Chinese Adult Male Patients With Androgenetic Alopecia (AGA)
- ClinicalTrials.gov ID
- NCT06126965
- Acronym / sponsor ID
- KX0826-CN-1003
- Conditions
- Androgenetic Alopecia
- Keywords
- KX-826, AGA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 740 participants (actual)
- Lead sponsor
- Suzhou Kintor Pharmaceutical Inc,Industry (pharma, biotech, devices)
- Collaborators
- Suzhou Koshine Biomedica, Inc.
- Study start
- 29 Dec 2021 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 13 Nov 2023 (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 is a phase III, multi-center, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of KX-826 for topical use in Chinese adult male patients with androgenetic alopecia (AGA).
Detailed description
In this study, around 740 adult male subjects with AGA (rating IIIv, IV and V on Hamilton-Norwood scale) were to be enrolled. All subjects would be evaluated with 1:1 randomized to receive active drug or placebo in a double-blind fashion (370 subjects in each group), and would be treated for 24 weeks at the specified dose and frequency of each group. During the study, the subjects would undergo periodic efficacy and safety-related examinations and evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KX-826-0.5% BID | Experimental | Drug: KX-826-（5%） BIDtreatment dose group of 0.5% BID(0.5%) |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Agree to follow the study treatment regimen and visit plan, voluntarily enroll in the study, and sign the ICF in writing;
- Male, ≥ 18 old;
- Clinically diagnosed as androgenetic alopecia;
- Rating IIIv, IV and V on Hamilton-Norwood scale;
Key exclusion criteria (6 listed)
- Have used androgen replacement therapy, immunosuppressants, corticosteroids and other drugs that may affect the efficacy evaluation within 3 months prior to screening;
- Have used minoxidil within 6 months prior to screening;
- Have used finasteride or dutasteride within 12 months prior to screening;
- Had used topical drugs for alopecia sites within 3 months prior to screening;
- Have received scalp radiation and/or laser or surgical therapy within 12 months prior to screening;
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 |
|---|---|---|
| KX-826-（5%） BIDAlso: KX-826-5 mg(5%)60mL BIDDosage and administration: Topical application, 7 sprays (approximately 1 ml)/time, in the target area of the scalp, starting from the center of the affected area and massaging with hands until absorption. It should be used when the hair and scalp are completely dry. Wash hands after use. The randomized active drug would be administered to the scalp once in the morning and once in the evening. | Drug | KX-826-0.5% BID |
| PlaceboDosage and administration: Topical application, 7 sprays (approximately 1 ml)/time, in the target area of the scalp, starting from the center of the affected area and massaging with hands until absorption. It should be used when the hair and scalp are completely dry. Wash hands after use. The randomized matching placebo would be administered to the scalp once in the morning and once in the evening. | Other | Placebo |
Primary outcome
change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24 in comparison to placebo).
Time frame: mean change from baseline after 24 weeks of treatment
change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24 in comparison to placebo).
2 secondary outcomes
Secondary Outcome Measure:
Time frame: change from baseline after 6, 12, 18, and 24 weeks of treatment, assessed using a 7-category method
Change in non-vellus hair diameter (width) in the target area (TAHW) (change from baseline at Weeks 6, 12, 18, 24 of treatment)
Time frame: change from baseline after 6, 12, 18, and 24 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
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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 principal investigator
Peking University People's Hospital
Qinping Yang principal investigator
Huashan Hospital
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KX-826-（5%） BID in people with Androgenetic Alopecia, run by Suzhou Kintor Pharmaceutical Inc, at 26 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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 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?
Results are not available in the source record.
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 non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24 in comparison to placebo). (time frame: mean change from baseline after 24 weeks of treatment). 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 Apr 2024.