Back to resultsPhase II Study Evaluating the Efficacy and Safety of KX-826
Primary Purpose
Androgenetic Alopecia (AGA)
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional treatment trial for Androgenetic Alopecia (AGA) focused on measuring KX-826 AGA
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Peking University First Hospital
- Peking University People's Hospital
- Dermatology Hospital of Southern Medical University
- Guangdong Provincial People's Hospital
- Affiliated Hospital of Jiangsu University
- Huashan Hospital
- Shanghai Dermatology Hospital
- Tianjin Medical University General Hospital
- The First Affiliated Hospital of Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
KX-826-2.5 mg BID
KX-826-5 mg QD
KX-826-5 mg BID
Placebo
Arm Description
treatment dose groups of 2.5 mg BID (0.25%)
treatment dose groups of 5 mg QD (0.5%)
treatment dose groups of 5 mg BID (0.5%)
Placebo
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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
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)
Full Information
NCT ID
NCT05940506
First Posted
July 4, 2023
Last Updated
July 17, 2023
Sponsor
Suzhou Kintor Pharmaceutical Inc,
1. Study Identification
Unique Protocol Identification Number
NCT05940506
Brief Title
Phase II Study Evaluating the Efficacy and Safety of KX-826
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 28, 2020 (Actual)
Primary Completion Date
July 8, 2021 (Actual)
Study Completion Date
August 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Kintor Pharmaceutical Inc,
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia (AGA)
Keywords
KX-826 AGA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KX-826-2.5 mg BID
Arm Type
Experimental
Arm Description
treatment dose groups of 2.5 mg BID (0.25%)
Arm Title
KX-826-5 mg QD
Arm Type
Experimental
Arm Description
treatment dose groups of 5 mg QD (0.5%)
Arm Title
KX-826-5 mg BID
Arm Type
Experimental
Arm Description
treatment dose groups of 5 mg BID (0.5%)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
KX-826-2.5 mg (0.25%)/60 mL BID
Other Intervention Name(s)
KX-826-2.5 mg (0.25%)/60 mL
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
KX-826-5 mg (5%)/60 mL QD
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
KX-826-5 mg (5%)/60 mL BID
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24).
Description
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
Secondary Outcome Measure Information:
Title
Hair growth assessment (HGA), including patient self-assessment, investigator assessment, and third-party professional physician assessment
Description
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
Title
Change in non-vellus hair diameter (width) in the target area (TAHW) (change from baseline at Weeks 6, 12, 18, 24 of treatment)
Description
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
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male, aged ≥ 18 years, in good general health;
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianzhong Zhang
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qinping Yang
Organizational Affiliation
Huashan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Dermatology Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Affiliated Hospital of Jiangsu University
City
Zhenjiang
State/Province
Jiangsu
Country
China
Facility Name
Huashan Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Dermatology Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
The First Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
Learn more about this trial
Phase II Study Evaluating the Efficacy and Safety of KX-826
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