- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07433933
Clinical Study to Evaluate Effect of Shampoo in Subjects With Hair Loss.
Clinical Study to Evaluate the Efficacy and Safety of a Cosmetic Product in Subjects With Telogen Effluvium and Androgenic Alopecia
The goal of this observational study is to learn about the effects of anti-hair loss shampoo in subjects over the age of 18 who use shampoo to treat their hair loss caused by telogen effluvium (TE) and androgenetic alopecia (AGA). The main question it aims to answer is:
• Does a shampoo use help to reduce the visible signs of hair loss related to TE and AGA?
Subjects will use the shampoo for 3 months and visit the clinic for the visits established by the protocol.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Madrid
-
Alcalá de Henares, Madrid, Spain, 28805
- Centro Médico Complutense Grupo Virtus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Sex: Both (50% women; 50% men).
- Age: 18-65 years.
- Subjects with hair loss due to telogen effluvium or mild or incipient androgenic alopecia, in an 80/20 ratio.
- Degree of androgenic alopecia: Ludwig scale score I-II for women and Hamilton-Norwood scale score III-II for men.
- Telogen effluvium: Combing test.
- Subjects with all hair types (oily, combination, sensitive, etc.).
- Subjects with all scalp types (normal, sensitive, etc.).
- Agree to participate voluntarily in the study and provide written informed consent.
- Adequate level of understanding of the clinical study.
- Good health (physical and mental).
- Availability to attend visits to the research centres.
- No application of any product to the experimental area on the first day of the trial.
Exclusion Criteria:
- Individuals under 18 years of age.
- Pregnant or breastfeeding women.
- Injuries or infection in the test area.
- History of allergies to cosmetic products.
- Known allergies to product components.
- Sensitivity to any product component.
- Patients who have undergone recent surgery or treatments in the study area.
- Cancer patients.
- Volunteers currently taking antibiotics, antihistamines, corticosteroids, beta-blockers, retinoids, azelaic acid, or acne therapies, or whose treatment ended within 15 days prior to the start of the study. Participation in another clinical study.
- Use of or having used cosmetic products and/or oral or topical treatments for hair loss for at least 6 months.
- Hair cutting or dyeing during the study.
- Health problems, to be assessed by the specialist, that may compromise adherence to the study protocol.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
anti-hair loss shampoo
|
anti-hair loss shampoo use for 3 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in hair lenght and thickness
Time Frame: From baseline to the end of use at 3 months.
|
From baseline to the end of use at 3 months.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in hair lenght and thickness at 1 month
Time Frame: Baseline and 1 month of use
|
Baseline and 1 month of use
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LACER_2406_COS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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