Androgenetic AlopeciaPhase 3NCT04825561
A Study to Evaluate the Efficacy and Safety of AD-208
A Phase 3 study testing AD-208 and AD-2081 in people with Androgenetic Alopecia, run by Addpharma Inc. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of AD-208. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- AD-208 and AD-2081
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Jun 2021to 1 Jun 2023
- Phase
- Phase 3
- 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 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male patients aged 18-50 years, inclusive
- Patients who meet the appropriate criteria according to the classification of hair loss
- Signed informed consent
Who cannot join
- Patients with hair loss disorders other than androgenetic alopecia
- Other exclusions applied
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AD-208 in Male Patients With Androgenetic Alopecia
The purpose of this study is to evaluate the efficacy and safety of AD-208.
Read the detailed description
The purpose of this study is to evaluate the efficacy and safety of AD-208 in male patients with androgenetic alopecia.
- Conditions
- Androgenetic Alopecia
- Being tested
- AD-208, AD-2081, placebo of AD-208, placebo of AD-2081
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-208Drug
PO, Once daily(QD), 24weeks
AD-2081Drug
PO, Once daily(QD), 24weeks
placebo of AD-208Drug
PO, Once daily(QD), 24weeks
placebo of AD-2081Drug
PO, Once daily(QD), 24weeks
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Active comparator | AD-208 and Placebo of AD-2081 Receives: Drug: AD-208; Drug: placebo of AD-2081 |
| Placebo Comparator | Placebo comparator | Placebo of AD-208 and Placebo of AD-2081 Receives: Drug: placebo of AD-208; Drug: placebo of AD-2081 |
| Experimental Comparator | Experimental | Placebo of AD-208 and AD-2081 Receives: Drug: AD-2081; Drug: placebo of AD-208 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of Change in the total number of hairs
The amount of change in the total number of hairs in the unit area
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 posted1 Apr 2021
- Study start9 Jun 2021
- Primary completion9 Jan 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- More trials run by Addpharma Inc.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addpharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825561
- Sponsor's protocol ID
- AD-208P3
- Status last verified
- Jul 2023
- First submitted
- 29 Mar 2021
- Last updated
- 21 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee S, Kim JE, Lew BL, Huh CH, Kim J, Kwon O, Kim MB, Lee YW, Lee Y, Park J, Kim S, Kim DY, Choi GS, Kang H. Efficacy and Safety of Low-Dose (0.2 mg) Dutasteride for Male Androgenic Alopecia: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Trial. Ann Dermatol. 2025 Aug;37(4):183-190. doi: 10.5021/ad.25.048.
PubMed 40736519
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AD-208 in Male Patients With Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT04825561
- Acronym / sponsor ID
- AD-208P3
- Conditions
- Androgenetic Alopecia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 9 Jan 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 1 Apr 2021 (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.
The purpose of this study is to evaluate the efficacy and safety of AD-208.
Detailed description
The purpose of this study is to evaluate the efficacy and safety of AD-208 in male patients with androgenetic alopecia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Active comparator | Drug: AD-208, Drug: placebo of AD-2081AD-208 and Placebo of AD-2081 |
| Placebo Comparator | Placebo comparator | Drug: placebo of AD-208, Drug: placebo of AD-2081Placebo of AD-208 and Placebo of AD-2081 |
| Experimental Comparator | Experimental | Drug: AD-2081, Drug: placebo of AD-208Placebo of AD-208 and AD-2081 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male patients aged 18-50 years, inclusive
- Patients who meet the appropriate criteria according to the classification of hair loss
- Signed informed consent
Key exclusion criteria (2 listed)
- Patients with hair loss disorders other than androgenetic alopecia
- Other exclusions applied
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 |
|---|---|---|
| AD-208PO, Once daily(QD), 24weeks | Drug | Active Comparator |
| AD-2081PO, Once daily(QD), 24weeks | Drug | Experimental Comparator |
| placebo of AD-208PO, Once daily(QD), 24weeks | Drug | Experimental Comparator, Placebo Comparator |
| placebo of AD-2081PO, Once daily(QD), 24weeks | Drug | Active Comparator, Placebo Comparator |
Primary outcome
The amount of Change in the total number of hairs
Time frame: Baseline, Week 24
The amount of change in the total number of hairs in the unit area
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 21 Jul 2023.
- Derived from this study: PubMed 40736519Lee S, Kim JE, Lew BL, Huh CH, Kim J, Kwon O, Kim MB, Lee YW, Lee Y, Park J, Kim S, Kim DY, Choi GS, Kang H. Efficacy and Safety of Low-Dose (0.2 mg) Dutasteride for Male Androgenic Alopecia: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Trial. Ann Dermatol. 2025 Aug;37(4):183-190. doi: 10.5021/ad.25.048.
- Individual participant dataSharing planned: No
Related trials for Androgenetic Alopecia
Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With 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)
Not yet recruiting
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AD-208 and AD-2081 in people with Androgenetic Alopecia, run by Addpharma Inc. 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 2 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 21 Jul 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The amount of Change in the total number of hairs (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?
On the ClinicalTrials.gov record for NCT04825561, which also lists 1 linked publication.
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 21 Jul 2023.