Androgenetic AlopeciaPhase 1/2NCT02280603
Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application
A Phase 1/2 study testing DA-4001C and 5% minoxidil in people with Androgenetic Alopecia, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
This study is designed to explore the efficacy and safety of DA-4001 after topical application in male patients with androgenetic alopecia Design : Randomized, double-blind, active-controlled study Investigational Product : Finasteride, minoxidil Read more about this study
- Who is it for?
- Ages 18 to 49 years, men only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- DA-4001C and 5% minoxidil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Dec 2014
- Phase
- Phase 1/2
- 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 to 49 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Basic and specific(BASP) classification : basic type is M2 or C2 and specific type is V1,V2 or F1,F2
Who cannot join
- Evidence of hair loss other than androgenetic alopecia
- Use of finasteride, dutasteride within previous 12 months
- Use of minoxidil within previous 6 months
- Use of androgenic or anti-androgenic agents within previous 6 months
- Use of steroid agents for local application to scalp or systemic application within previous 1 month
- History of hair transplantation, scalp reduction
- Coronary artery disease, arrhythmia, congestive heart failure, valvular haert disease, angina pectoris
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Active-controlled, Randomized, Double-blind, Proof of Concept Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application in Male Patients With Androgenetic Alopecia
This study is designed to explore the efficacy and safety of DA-4001 after topical application in male patients with androgenetic alopecia
Design : Randomized, double-blind, active-controlled study
Investigational Product : Finasteride, minoxidil
- Conditions
- Androgenetic Alopecia
- Being tested
- DA-4001C, 5% minoxidil
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-4001CDrug
1ml by topical application twice a day
5% minoxidilDrug
Also called minoxyl
1ml by topical application twice a day
| Study group | Role | What they receive |
|---|---|---|
| DA-4001C | Experimental | DA-4001C is administered Receives: Drug: DA-4001C |
| 5% minoxidil | Active comparator | 5% minoxidil is administered Receives: Drug: 5% minoxidil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in target area hair count per cm2 at week 24, as assessed by phototrichogram
Measured: baseline and week 24
Secondary outcomes (3)
Change from baseline in target area hair count per cm2 at week 16, as assessed by phototrichogram
Measured: Baseline and week 16
Improvement rate of target area hair count per cm2 at week 16 and week 24, as assessed by phototrichogram
Measured: Baseline, week 16,and week24
Improvement rate of target area mean hair diameter at week 16 and week 24, as assessed by phototrichogram
Measured: Baseline, week 16, and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2014
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hoon Kang, M.D, Ph.D, Principal investigator, The catholic univ. of korea, St.Paul's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280603
- Sponsor's protocol ID
- DA4001_AGAP_POC
- Status last verified
- Jun 2015
- First submitted
- 29 Oct 2014
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Active-controlled, Randomized, Double-blind, Proof of Concept Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application in Male Patients With Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT02280603
- Acronym / sponsor ID
- DA4001_AGAP_POC
- Conditions
- Androgenetic Alopecia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 31 Oct 2014 (estimated)
- 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 study is designed to explore the efficacy and safety of DA-4001 after topical application in male patients with androgenetic alopecia
Design : Randomized, double-blind, active-controlled study
Investigational Product : Finasteride, minoxidil
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA-4001C | Experimental | Drug: DA-4001CDA-4001C is administered |
| 5% minoxidil | Active comparator | Drug: 5% minoxidil5% minoxidil is administered |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Basic and specific(BASP) classification : basic type is M2 or C2 and specific type is V1,V2 or F1,F2
Key exclusion criteria (7 listed)
- Evidence of hair loss other than androgenetic alopecia
- Use of finasteride, dutasteride within previous 12 months
- Use of minoxidil within previous 6 months
- Use of androgenic or anti-androgenic agents within previous 6 months
- Use of steroid agents for local application to scalp or systemic application within previous 1 month
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 |
|---|---|---|
| DA-4001C1ml by topical application twice a day | Drug | DA-4001C |
| 5% minoxidilAlso: minoxyl1ml by topical application twice a day | Drug | 5% minoxidil |
Primary outcome
Change from baseline in target area hair count per cm2 at week 24, as assessed by phototrichogram
Time frame: baseline and week 24
3 secondary outcomes
Change from baseline in target area hair count per cm2 at week 16, as assessed by phototrichogram
Time frame: Baseline and week 16
Improvement rate of target area hair count per cm2 at week 16 and week 24, as assessed by phototrichogram
Time frame: Baseline, week 16,and week24
Improvement rate of target area mean hair diameter at week 16 and week 24, as assessed by phototrichogram
Time frame: Baseline, week 16, and week 24
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 24 Jun 2015.
Related trials for Androgenetic Alopecia
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Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
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Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
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Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
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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.
Hoon Kang, M.D, Ph.D principal investigator
The catholic univ. of korea, St.Paul's hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DA-4001C and 5% minoxidil in people with Androgenetic Alopecia, run by Dong-A ST Co., Ltd. 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 1 inclusion and 7 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 24 Jun 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 from baseline in target area hair count per cm2 at week 24, as assessed by phototrichogram (time frame: baseline and 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 24 Jun 2015.