A Phase 2 interventional study of KX-826-2.5 mg (0.25%)/60 mL BID and KX-826-5 mg (5%)/60 mL QD in Androgenetic Alopecia (AGA), sponsored by Suzhou Kintor Pharmaceutical Inc,. Completed at 9 sites in China. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-19.
Sponsored by Suzhou Kintor Pharmaceutical Inc, · Phase 2, Interventional, and Treatment
This is a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study of KX-826 in Chinese adult male patients with AGA.
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.
609 studies on the registry are indexed under Alopecia; 131 are open to participants now.
This study's enrollment of 120 is above the median of 45 across 513 interventional studies indexed under Alopecia.
Browse Alopecia studies →Suzhou Kintor Pharmaceutical Inc, is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
treatment dose groups of 2.5 mg BID (0.25%)
Drug: KX-826-2.5 mg (0.25%)/60 mL BID
treatment dose groups of 5 mg QD (0.5%)
Drug: KX-826-5 mg (5%)/60 mL QD
treatment dose groups of 5 mg BID (0.5%)
Drug: KX-826-5 mg (5%)/60 mL BID
Placebo
Other: Placebo
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.
Also known as: 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 in the evening once daily.
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.
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.
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).
Time frame: mean change from baseline after 24 weeks of treatment
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
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)
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
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Suzhou Kintor Pharmaceutical Inc,