ClinicalTrials.gg
Not yet recruitingNCT06355856CAPELLIUpdated Apr 10, 2024

Efficacy/ Safety of DNN.22.17.036 in Male Patients With Pattern Hair Loss

A Phase 4 interventional study of DNN.22.17.036 and 10573048700 in Alopecia, sponsored by Ache Laboratorios Farmaceuticos S.A.. Not yet recruiting. Open to male participants aged 25 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-04-10.

Sponsored by Ache Laboratorios Farmaceuticos S.A. · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
196
Allocation
Randomized
Ages
25 Years to 60 Years
Sex
Male
01

Study summary

Evaluation of the efficacy and safety of DNN.22.17.036 versus 10573048700 in the treatment of male pattern hair loss.

02

Conditions studied

  • Alopecia

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03

In context

Alopecia

511 studies on the registry are indexed under Alopecia; 128 are open to participants now.

This study's planned enrollment of 196 is above the median of 50 across 430 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

Ache Laboratorios Farmaceuticos S.A. is the lead sponsor of 36 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Ability to understand and consent to participate in this clinical research, expressed by signing the 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

Exclusion criteria

Exclusion Criteria:

  • Participants who have used 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, , hematologic disorders, thyroid dysfunction, malnutrition, and other dermatologic disorders that contribute to hair loss
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
196 participants (estimated)

Study arms

  • Experimental
    DNN.22.17.036

    Apply 1 ml to the bald area of the scalp, twice a day for 180 days.

    Drug: DNN.22.17.036

  • Active comparator
    10573048700

    Apply 1 ml to the bald area of the scalp, twice a day for 180 days.

    Drug: 10573048700

Interventions

  • DrugDNN.22.17.036

    Apply twice daily to the affected area and around it.

  • Drug10573048700

    Apply twice daily to the affected area and around it.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 180 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Apr 2024; primary completion for May 2025, 13 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 4, 2024
First posted
Apr 10, 2024
StartEst.
Apr 2024
Primary completionEst.
May 2025
CompletionEst.
May 2025
Last update
Apr 10, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06355856
Responsible party
Sponsor
First posted
Apr 10, 2024
Start date
Apr 2024 (estimated)
Primary completion
May 2025 (estimated)
Completion
May 2025 (estimated)
Last update
Apr 10, 2024

Study contacts

Renata Herrera
Contact
pesquisa.clinica@ache.com.br
(55-11) 97216-3958

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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