Androgenetic AlopeciaPhase 2NCT05677438
A Phase 2 Study to Evaluate the Safety and Efficacy of CKD-498 in Female Patients With Androgenetic Alopecia
A Phase 2 study testing CKD-498 dose#1, CKD-498 dose#2 and CKD-498 dose#3 in people with Androgenetic Alopecia, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
This is a multi-centers, randomized, double-blind, parallel-group, Phase 2 Trial to evaluate the efficacy and safety of CKD-498 in female patients with Androgenetic Alopecia Read more about this study
- Who is it for?
- Ages 19 to 54 years, women only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- CKD-498 dose#1, CKD-498 dose#2 and CKD-498 dose#3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Dec 2022to 15 Dec 2023
- 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 19 to 54 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female of age 19-54 years
- Clinical Diagnosis of Androgenetic Alopecia
- Written informed consent
Who cannot join
- 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
- Women who are pregnant or breastfeeding
- Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of study drug
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Gyeonggi-do, 13620
About this study
Official title: A Phase 2, Randomized, Double-blind, Multi-center, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-498 in Female Patients With Androgenetic Alopecia
This is a multi-centers, randomized, double-blind, parallel-group, Phase 2 Trial to evaluate the efficacy and safety of CKD-498 in female patients with Androgenetic Alopecia
Read the detailed description
Participants were randomly assigned in a 1:1:1:1 ratio to the following group: 3 dose of CKD-498 and Placebo. The patients are prescribed oral administration of the appropriate IP daily (3 tablets: actual medication and placebo) for 24 weeks.
- Conditions
- Androgenetic Alopecia
- Being tested
- CKD-498 dose#1, CKD-498 dose#2, CKD-498 dose#3, Placebo of CKD-498 dose#1, Placebo of CKD-498 dose#2
- Keywords
- Androgenetic Alopecia, CKD-498
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-498 dose#1Drug
oral, once daily, 24 weeks
CKD-498 dose#2Drug
oral, once daily, 24 weeks
CKD-498 dose#3Drug
oral, once daily, 24 weeks
Placebo of CKD-498 dose#1Drug
oral, once daily, 24 weeks
Placebo of CKD-498 dose#2Drug
oral, once daily, 24 weeks
Placebo of CKD-498 dose#3Drug
oral, once daily, 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Test Group1 | Experimental | Not described Receives: Drug: CKD-498 dose#1; Drug: Placebo of CKD-498 dose#2; Drug: Placebo of CKD-498 dose#3 |
| Test Group2 | Experimental | Not described Receives: Drug: CKD-498 dose#2; Drug: Placebo of CKD-498 dose#1; Drug: Placebo of CKD-498 dose#3 |
| Test Group3 | Experimental | Not described Receives: Drug: CKD-498 dose#3; Drug: Placebo of CKD-498 dose#1; Drug: Placebo of CKD-498 dose#2 |
| Placebo Group | Placebo comparator | Not described Receives: Drug: Placebo of CKD-498 dose#1; Drug: Placebo of CKD-498 dose#2; Drug: Placebo of CKD-498 dose#3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of hair Changes
from Baseline at Week24 of total number of hair changes
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start20 Dec 2022
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ChangHun Huh, MD, PhD., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677438
- Sponsor's protocol ID
- A128_01AGA2211
- Status last verified
- Jun 2024
- First submitted
- 23 Dec 2022
- Last updated
- 28 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Multi-center, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-498 in Female Patients With Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT05677438
- Acronym / sponsor ID
- A128_01AGA2211
- Conditions
- Androgenetic Alopecia
- Keywords
- Androgenetic Alopecia, CKD-498
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 10 Jan 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-centers, randomized, double-blind, parallel-group, Phase 2 Trial to evaluate the efficacy and safety of CKD-498 in female patients with Androgenetic Alopecia
Detailed description
Participants were randomly assigned in a 1:1:1:1 ratio to the following group: 3 dose of CKD-498 and Placebo. The patients are prescribed oral administration of the appropriate IP daily (3 tablets: actual medication and placebo) for 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test Group1 | Experimental | Drug: CKD-498 dose#1, Drug: Placebo of CKD-498 dose#2, Drug: Placebo of CKD-498 dose#3 |
| Test Group2 | Experimental | Drug: CKD-498 dose#2, Drug: Placebo of CKD-498 dose#1, Drug: Placebo of CKD-498 dose#3 |
| Test Group3 | Experimental | Drug: CKD-498 dose#3, Drug: Placebo of CKD-498 dose#1, Drug: Placebo of CKD-498 dose#2 |
| Placebo Group | Placebo comparator | Drug: Placebo of CKD-498 dose#1, Drug: Placebo of CKD-498 dose#2, Drug: Placebo of CKD-498 dose#3 |
Who may qualify
- Ages
- 19 to 54 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female of age 19-54 years
- Clinical Diagnosis of Androgenetic Alopecia
- Written informed consent
Key exclusion criteria (5 listed)
- 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
- Women who are pregnant or breastfeeding
- Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of study drug
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 |
|---|---|---|
| CKD-498 dose#1oral, once daily, 24 weeks | Drug | Test Group1 |
| CKD-498 dose#2oral, once daily, 24 weeks | Drug | Test Group2 |
| CKD-498 dose#3oral, once daily, 24 weeks | Drug | Test Group3 |
| Placebo of CKD-498 dose#1oral, once daily, 24 weeks | Drug | Placebo Group, Test Group2, Test Group3 |
| Placebo of CKD-498 dose#2oral, once daily, 24 weeks | Drug | Placebo Group, Test Group1, Test Group3 |
| Placebo of CKD-498 dose#3oral, once daily, 24 weeks | Drug | Placebo Group, Test Group1, Test Group2 |
Primary outcome
Total number of hair Changes
Time frame: Baseline, Week 24
from Baseline at Week24 of total number of hair changes
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 28 Jun 2024.
- Individual participant dataSharing planned: No
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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.
ChangHun Huh, MD, PhD. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CKD-498 dose#1, CKD-498 dose#2 and CKD-498 dose#3 in people with Androgenetic Alopecia, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
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 3 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 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
Total number of hair Changes (time frame: Baseline, Week 24). 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 28 Jun 2024.