Androgenetic Alopecia (AGA)Phase 2NCT05940506

Phase II Study Evaluating the Efficacy and Safety of KX-826

A Phase 2 study testing KX-826-2.5 mg (0.25%)/60 mL BID, KX-826-5 mg (5%)/60 mL QD and KX-826-5 mg (5%)/60 mL BID in people with Androgenetic Alopecia (AGA), run by Suzhou Kintor Pharmaceutical Inc, at 9 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study of KX-826 in Chinese adult male patients with AGA. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Androgenetic Alopecia (AGA)
What is being tested?: KX-826-2.5 mg (0.25%)/60 mL BID, KX-826-5 mg (5%)/60 mL QD and KX-826-5 mg (5%)/60 mL BID
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 9 sitesChina
Study dates: 28 Sep 2020to 18 Aug 2021
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 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Agreeing to follow the study treatment regimen and visit plan, voluntarily enroll the study, and sign the informed consent form (ICF) in writing;
Male, aged ≥ 18 years, in good general health;
Clinical diagnosis of AGA;
Stage IIIv, IV and V according to Hamilton-Norwood scale.

Who cannot join

Patients who have used external topical drugs for alopecia sites within 3 months prior to screening;
Patients who have taken androgen replacement therapy； immunosuppressants, corticosteroids and other drugs that may interfere with the efficacy evaluation within 3 months prior to screening;
Minoxidil use within 6 months prior to screening;
Treatment with finasteride or dutasteride within 12 months prior to screening; Scalp radiation and/or laser or surgical therapy within 12 months prior to screening; History of malignancy;
Other conditions that may affect compliance or ineligibility for participation of the study.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

China9 sites

Peking University First Hospital
Beijing, Beijing Municipality
Peking University People's Hospital
Beijing, Beijing Municipality
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Huashan Hospital
Shanghai, Shanghai Municipality
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu

Other trials in China

About this study

Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of KX-826 Tincture in the Treatment of Adult Male Androgenetic Alopecia (AGA) Patients in China

This is a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study of KX-826 in Chinese adult male patients with AGA.

Read the detailed description

Based on the results of the Phase I studies of KX-826 in Androgenetic Alopecia and the pre-clinical PD studies, the investigational product will be administered at 2.5 mg BID (0.25%), 5 mg QD (0.5%), and 5 mg BID (0.5%) in treatment groups A, B, and C, respectively, with 30 patients/group; a total of 30 patients will be administered in the placebo QD group (10) and placebo BID group (20). The investigational product will be administered in the evening once daily for all QD dose groups, and once in the morning and once in the evening for the BID dose groups.

Conditions: Androgenetic Alopecia (AGA)
Being tested: KX-826-2.5 mg (0.25%)/60 mL BID, KX-826-5 mg (5%)/60 mL QD, KX-826-5 mg (5%)/60 mL 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-826-2.5 mg (0.25%)/60 mL BIDDrug
Also called KX-826-2.5 mg (0.25%)/60 mL
Topical application, 7 sprays (approximately 1 mL)/time, in the target area of the scalp (8 cm × 8 cm), starting from the center of the affected area, and massage with hands for 3-5 min. This dose is used regardless of the size of the affected area. It should be used when hair and scalp are completely dry. Wash hands after use. The control product will be administered once in the morning and once in the evening.
KX-826-5 mg (5%)/60 mL QDDrug
Topical application, 7 sprays (approximately 1 mL)/time, in the target area of the scalp (8 cm × 8 cm), starting from the center of the affected area, and massage with hands for 3-5 min. This dose is used regardless of the size of the affected area. It should be used when hair and scalp are completely dry. Wash hands after use. The control product will be administered in the evening once daily.
KX-826-5 mg (5%)/60 mL BIDDrug
Topical application, 7 sprays (approximately 1 mL)/time, in the target area of the scalp (8 cm × 8 cm), starting from the center of the affected area, and massage with hands for 3-5 min. This dose is used regardless of the size of the affected area. It should be used when hair and scalp are completely dry. Wash hands after use. The control product will be administered once in the morning and once in the evening.
PlaceboOther
Topical application, 7 sprays (approximately 1 mL)/time, in the target area of the scalp (8 cm × 8 cm),starting from the center of the affected area, and massage with hands for 3-5 min. This dose is used regardless of the size of the affected area. It should be used when hair and scalp are completely dry. Wash hands after use. The control product will be administered in the evening once daily for QD dose groups, and once in the morning and once in the evening for the BID dose groups.

Study groups in NCT05940506
Study group	Role	What they receive
KX-826-2.5 mg BID	Experimental	treatment dose groups of 2.5 mg BID (0.25%) Receives: Drug: KX-826-2.5 mg (0.25%)/60 mL BID
KX-826-5 mg QD	Experimental	treatment dose groups of 5 mg QD (0.5%) Receives: Drug: KX-826-5 mg (5%)/60 mL QD
KX-826-5 mg BID	Experimental	treatment dose groups of 5 mg BID (0.5%) Receives: Drug: KX-826-5 mg (5%)/60 mL 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).
change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24).
Measured: mean change from baseline after 24 weeks of treatment

Secondary outcomes (2)

Hair growth assessment (HGA), including patient self-assessment, investigator assessment, and third-party professional physician assessment
Hair growth assessment (HGA), including patient self-assessment, investigator assessment, and third-party professional physician 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.

28 Sep 202018 Aug 2021

First posted11 Jul 2023
Study start28 Sep 2020
Primary completion8 Jul 2021
Study completion18 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Androgenetic Alopecia (AGA)Studies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05940506
Sponsor's protocol ID: KX0826-CN-1002
Status last verified: Jul 2023
First submitted: 4 Jul 2023
Last updated: 19 Jul 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia

All Androgenetic Alopecia (AGA) trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of KX-826 Tincture in the Treatment of Adult Male Androgenetic Alopecia (AGA) Patients in China
ClinicalTrials.gov ID: NCT05940506
Acronym / sponsor ID: KX0826-CN-1002
Conditions: Androgenetic Alopecia (AGA)
Keywords: KX-826 AGA
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Suzhou Kintor Pharmaceutical Inc,Industry (pharma, biotech, devices)
Study start: 28 Sep 2020 (actual)
Primary completion: 8 Jul 2021 (actual)
Study completion: 18 Aug 2021 (actual)
First posted: 11 Jul 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 multi-center, randomized, double-blind, placebo-controlled Phase II clinical study of KX-826 in Chinese adult male patients with AGA.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
KX-826-2.5 mg BID	Experimental	Drug: KX-826-2.5 mg (0.25%)/60 mL BIDtreatment dose groups of 2.5 mg BID (0.25%)
KX-826-5 mg QD	Experimental	Drug: KX-826-5 mg (5%)/60 mL QDtreatment dose groups of 5 mg QD (0.5%)
KX-826-5 mg BID	Experimental	Drug: KX-826-5 mg (5%)/60 mL BIDtreatment dose groups of 5 mg 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)

Agreeing to follow the study treatment regimen and visit plan, voluntarily enroll the study, and sign the informed consent form (ICF) in writing;
Male, aged ≥ 18 years, in good general health;
Clinical diagnosis of AGA;
Stage IIIv, IV and V according to Hamilton-Norwood scale.

Key exclusion criteria (5 listed)

Patients who have used external topical drugs for alopecia sites within 3 months prior to screening;
Patients who have taken androgen replacement therapy； immunosuppressants, corticosteroids and other drugs that may interfere with the efficacy evaluation within 3 months prior to screening;
Minoxidil use within 6 months prior to screening;
Treatment with finasteride or dutasteride within 12 months prior to screening; Scalp radiation and/or laser or surgical therapy within 12 months prior to screening; History of malignancy;
Other conditions that may affect compliance or ineligibility for participation of the study.

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-826-2.5 mg (0.25%)/60 mL BIDAlso: KX-826-2.5 mg (0.25%)/60 mLTopical application, 7 sprays (approximately 1 mL)/time, in the target area of the scalp (8 cm × 8 cm), starting from the center of the affected area, and massage with hands for 3-5 min. This dose is used regardless of the size of the affected area. It should be used when hair and scalp are completely dry. Wash hands after use. The control product will be administered once in the morning and once in the evening.	Drug	KX-826-2.5 mg BID
KX-826-5 mg (5%)/60 mL QDTopical application, 7 sprays (approximately 1 mL)/time, in the target area of the scalp (8 cm × 8 cm), starting from the center of the affected area, and massage with hands for 3-5 min. This dose is used regardless of the size of the affected area. It should be used when hair and scalp are completely dry. Wash hands after use. The control product will be administered in the evening once daily.	Drug	KX-826-5 mg QD
KX-826-5 mg (5%)/60 mL BIDTopical application, 7 sprays (approximately 1 mL)/time, in the target area of the scalp (8 cm × 8 cm), starting from the center of the affected area, and massage with hands for 3-5 min. This dose is used regardless of the size of the affected area. It should be used when hair and scalp are completely dry. Wash hands after use. The control product will be administered once in the morning and once in the evening.	Drug	KX-826-5 mg BID
PlaceboTopical application, 7 sprays (approximately 1 mL)/time, in the target area of the scalp (8 cm × 8 cm),starting from the center of the affected area, and massage with hands for 3-5 min. This dose is used regardless of the size of the affected area. It should be used when hair and scalp are completely dry. Wash hands after use. The control product will be administered in the evening once daily for QD dose groups, and once in the morning and once in the evening for the BID dose groups.	Other	Placebo

Primary outcome

change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24).
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).

2 secondary outcomes

Hair growth assessment (HGA), including patient self-assessment, investigator assessment, and third-party professional physician assessment
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

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 19 Jul 2023.

Related trials for Androgenetic Alopecia (AGA)

Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia

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

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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 in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24). (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?

On the ClinicalTrials.gov record for NCT05940506.

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 19 Jul 2023.