AlopeciaPhase 4CAPELLINCT06355856
Efficacy/ Safety of DNN.22.17.036 in Male Patients With Pattern Hair Loss
A Phase 4 study testing DNN.22.17.036 and 10573048700 in people with Alopecia, run by Ache Laboratorios Farmaceuticos S.A..
Trial summary
Evaluation of the efficacy and safety of DNN.22.17.036 versus 10573048700 in the treatment of male pattern hair loss. Read more about this study
- Who is it for?
- Ages 25 to 60 years, men only
- Conditions the study is for
- Alopecia
- What is being tested?
- DNN.22.17.036 and 10573048700
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to May 2025
- Phase
- Phase 4
- 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 25 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Ability to understand and consent to participate in this clinical research, expressed by signing the Informed Consent Form (ICF)
- Male participants age 25 or older and 60 age or younger
- Participants who have an intact scalp in the area of product analysis
- Participants with androgenetic alopecia (AGA) with AGA Norwood-Hamilton Scale > II
- Participants with at least 20% telogen effluvium of evaluated by Tricholab
Who cannot join
- Participants who have used immunosuppressants in the 3 months prior to signing the ICF
- Participants with other causes of hair loss or scalp dermatoses
- Participants who have received hair loss treatment in the last 6 months
- Participants with uncontrolled medical conditions, kidney and liver disease
- Participants with a history of hair transplantation, malignancy, hematologic disorders, thyroid dysfunction, malnutrition, and other dermatologic disorders that contribute to hair loss
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase IV, National, Unicentric, Comparative, Double-Blind, Randomized, Non- Inferiority Clinical Trial to Evaluate the Efficacy and Safety of DNN.22.17.036 Compared to 10573048700 in the Treatment of Androgenetic Alopecia
Evaluation of the efficacy and safety of DNN.22.17.036 versus 10573048700 in the treatment of male pattern hair loss.
- Conditions
- Alopecia
- Being tested
- DNN.22.17.036, 10573048700
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNN.22.17.036Drug
Apply twice daily to the affected area and around it.
10573048700Drug
Apply twice daily to the affected area and around it.
| Study group | Role | What they receive |
|---|---|---|
| DNN.22.17.036 | Experimental | Apply 1 ml to the bald area of the scalp, twice a day for 180 days. Receives: Drug: DNN.22.17.036 |
| 10573048700 | Active comparator | Apply 1 ml to the bald area of the scalp, twice a day for 180 days. Receives: Drug: 10573048700 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage variation of hairs in the hair loss phase
Percentage variation of hairs in the hair loss phase (telogen hairs), by image analysis with the FotoFinder Leviacam®, after 180 days of treatment.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355856
- Sponsor's protocol ID
- ACH-PNT-04(01/22)
- Acronym
- CAPELLI
- Status last verified
- Mar 2024
- First submitted
- 4 Apr 2024
- Last updated
- 10 Apr 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 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV, National, Unicentric, Comparative, Double-Blind, Randomized, Non- Inferiority Clinical Trial to Evaluate the Efficacy and Safety of DNN.22.17.036 Compared to 10573048700 in the Treatment of Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT06355856
- Acronym / sponsor ID
- CAPELLI / ACH-PNT-04(01/22)
- Conditions
- Alopecia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- Apr 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 10 Apr 2024 (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.
Evaluation of the efficacy and safety of DNN.22.17.036 versus 10573048700 in the treatment of male pattern hair loss.
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 |
|---|---|---|
| DNN.22.17.036 | Experimental | Drug: DNN.22.17.036Apply 1 ml to the bald area of the scalp, twice a day for 180 days. |
| 10573048700 | Active comparator | Drug: 10573048700Apply 1 ml to the bald area of the scalp, twice a day for 180 days. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Ability to understand and consent to participate in this clinical research, expressed by signing the Informed Consent Form (ICF)
- Male participants age 25 or older and 60 age or younger
- Participants who have an intact scalp in the area of product analysis
- Participants with androgenetic alopecia (AGA) with AGA Norwood-Hamilton Scale > II
- Participants with at least 20% telogen effluvium of evaluated by Tricholab
Key exclusion criteria (5 listed)
- Participants who have used immunosuppressants in the 3 months prior to signing the ICF
- Participants with other causes of hair loss or scalp dermatoses
- Participants who have received hair loss treatment in the last 6 months
- Participants with uncontrolled medical conditions, kidney and liver disease
- Participants with a history of hair transplantation, malignancy, hematologic disorders, thyroid dysfunction, malnutrition, and other dermatologic disorders that contribute to hair loss
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 |
|---|---|---|
| DNN.22.17.036Apply twice daily to the affected area and around it. | Drug | DNN.22.17.036 |
| 10573048700Apply twice daily to the affected area and around it. | Drug | 10573048700 |
Primary outcome
Percentage variation of hairs in the hair loss phase
Time frame: 180 days
Percentage variation of hairs in the hair loss phase (telogen hairs), by image analysis with the FotoFinder Leviacam®, after 180 days of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DNN.22.17.036 and 10573048700 in people with Alopecia, run by Ache Laboratorios Farmaceuticos S.A..
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 5 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: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renata Herrera ((55-11) 97216-3958, pesquisa.clinica@ache.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage variation of hairs in the hair loss phase (time frame: 180 days). 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 10 Apr 2024.