Health TrialsbyHealthPanel

A Phase 3 Study to Evaluate the Safety and Efficacy of CKD-843 in Male Patients With Androgenetic Alopecia

ConditionAndrogenetic Alopecia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18-50
SponsorChong Kun Dang Pharmaceutical

About this trial

This is a multi-centers, randomized, double-blind, parallel-group, Phase 3 Trial to evaluate the efficacy and safety of CKD-843 in Male patients with Androgenetic Alopecia

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male of age 18-50 years

Clinical Diagnosis of Androgenetic Alopecia

Written informed consent

Disqualifiers

Other types of Alopecia or other diseases that can cause hair loss

Clinically significant scalp disease such as seborrheic dermatitis or psoriasis

Clinically significant hepatic disease, thyroid disease, or mental illness, as determined by the Investigator

Participants who do not agree to use contraception during the trial and for 24 weeks after the last dose, and plan to provide sperm or conceive within 24 weeks after the last dose

Trial design

Design model

Parallel

Treatments tested in this trial

  • CKD-843 dose#1

    Drug

    IM injection every 3 months for 12 months

  • CKD-843 dose#2

    Drug

    IM injection every 3 months for 12 months

  • Placebo of CKD-843 dose

    Drug

    IM injection every 3 months for 12 months

  • Dutasteride Capsules

    Drug

    oral, once daily, 12 months

  • Placebo of Dutasteride Capsule

    Drug

    oral, once daily, 12 months

Treatment groups

288 Participants
are divided into 4 treatment groups
Group A: Test Group1Experimental treatment 2 interventions
Group B: Test Group2Experimental treatment 2 interventions
Group C: Placebo-controlled GroupPlacebo comparator 2 interventions
Group D: Active-controlled GroupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Total number of hair Changes

from Baseline at Week24 of total number of hair changes

Time frame
Baseline, Week 24

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chong Kun Dang Pharmaceutical

Lead sponsor

Source ClinicalTrials.gov
Apply now