Back to resultsExploratory Clinical Trial of Safety and Efficacy of Daily Application of Topical Dutasteride in Men With Androgenic Alopecia.
Primary Purpose
Male Androgenetic Alopecia
Status
Active
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Dutasteride
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Male Androgenetic Alopecia
Eligibility Criteria
Inclusion Criteria: • - Males over 18 years of age, diagnosed with Sinclair grades I-IV androgenic alopecia, who are not currently undergoing any hair treatment and have not undergone any in the last 3 months. - Understand the purpose of the study and be available for frequent visits to the hospital. Sign the informed consent form. - Males with a partner of childbearing age must agree to use a contraceptive method with the partner for the duration of the study. Exclusion Criteria: • - Patients with a history of hypersensitivity to the active ingredient, to other 5-alpha reductase inhibitors. - Patients with severe hepatic insufficiency. - Patients who are currently undergoing capillary treatment or have undergone capillary treatment in the last 3 months. - Patients unable to understand the objective of the study or to give informed consent. - Patients who, in the opinion of the investigator, present any difficulty or situation that would hinder or contraindicate their participation in this study. - Patients with a history of drug addiction and drug addictions. - Patients who are participating in another clinical trial. - Patients whose partner is pregnant
Sites / Locations
- Hospital Ramón y Cajal
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
experimental drug
Placebo
Arm Description
0.15% w/w dutasteride topical O/W emulsion.
vehicle (excipients)
Outcomes
Primary Outcome Measures
Safety and Tolerability
Local adverse events (AEs) and systemic adverse reactions
- Hair microbiome analysis
Secondary Outcome Measures
Efficacy in hair loss reduction
Clinical improvement. Standardized photographs will be taken
Full Information
NCT ID
NCT05599243
First Posted
October 3, 2022
Last Updated
May 26, 2023
Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
1. Study Identification
Unique Protocol Identification Number
NCT05599243
Brief Title
Exploratory Clinical Trial of Safety and Efficacy of Daily Application of Topical Dutasteride in Men With Androgenic Alopecia.
Official Title
Exploratory Clinical Trial of Safety and Efficacy of Daily Application of Topical Dutasteride in Men With Androgenic Alopecia.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 29, 2022 (Actual)
Primary Completion Date
April 29, 2024 (Anticipated)
Study Completion Date
April 29, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Alopecia is a disorder that involves the loss of hair from the body. The causes of hair loss can be multiple, but in all cases this loss causes a lot of discomfort to patients for aesthetic and psychological reasons, especially in the female population.This study is going to focus on the topical use of dutasteride in the treatment of men with androgenic alopecia using a new formulation, as an emulsion, capable of transporting this drug to the different structures of the pilosebaceous unit.
Detailed Description
Alopecia is a disorder that involves the loss of hair from the body. The causes of hair loss can be multiple, but in all cases this loss causes a lot of discomfort to patients for aesthetic and psychological reasons, especially in the female population. This disorder, although more visible in men, is suffered by both men and women. Recent studies show that the stress experienced by patients with alopecia can be similar or greater than that suffered by a more serious or chronic disease. For all these reasons, alopecia can prefer a social problem without a definitive therapeutic solution.This study is going to focus on the topical use of dutasteride in the treatment of men with androgenic alopecia using a new formulation, as an emulsion, capable of transporting this drug to the different structures of the pilosebaceous unit. The lipid nature of the formulation and the droplet size of between 150-300 nm means that the emulsion drops easily penetrate the hair follicle and accumulate in the sebaceous glands of said follicles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Androgenetic Alopecia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double blind placebo controlled
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental drug
Arm Type
Experimental
Arm Description
0.15% w/w dutasteride topical O/W emulsion.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
vehicle (excipients)
Intervention Type
Drug
Intervention Name(s)
Dutasteride
Intervention Description
The application will be made locally (spray for topical application on the scalp) Application: 1 mL (6 sprays) once a day. Each 1mL of formulation has approximately 1.5mg of Dutasteride (more precisely it would be 1.4835mg when considering density).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Vehicle excipient
Primary Outcome Measure Information:
Title
Safety and Tolerability
Description
Local adverse events (AEs) and systemic adverse reactions
- Hair microbiome analysis
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Efficacy in hair loss reduction
Description
Clinical improvement. Standardized photographs will be taken
Time Frame
7 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• - Males over 18 years of age, diagnosed with Sinclair grades I-IV androgenic alopecia, who are not currently undergoing any hair treatment and have not undergone any in the last 3 months.
- Understand the purpose of the study and be available for frequent visits to the hospital. Sign the informed consent form.
- Males with a partner of childbearing age must agree to use a contraceptive method with the partner for the duration of the study.
Exclusion Criteria:
• - Patients with a history of hypersensitivity to the active ingredient, to other 5-alpha reductase inhibitors.
- Patients with severe hepatic insufficiency.
- Patients who are currently undergoing capillary treatment or have undergone capillary treatment in the last 3 months.
- Patients unable to understand the objective of the study or to give informed consent.
- Patients who, in the opinion of the investigator, present any difficulty or situation that would hinder or contraindicate their participation in this study.
- Patients with a history of drug addiction and drug addictions.
- Patients who are participating in another clinical trial.
- Patients whose partner is pregnant
Facility Information:
Facility Name
Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exploratory Clinical Trial of Safety and Efficacy of Daily Application of Topical Dutasteride in Men With Androgenic Alopecia.
We'll reach out to this number within 24 hrs