NCT07358403
Completed
Not Applicable
Clinical Instrumental Evaluation of the Efficacy of a Dietary Supplement Claiming Anti Hair Loss Properties
Lacer S.A.1 site in 1 country240 target enrollmentStarted: November 4, 2024Last updated:
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Lacer S.A.
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Change from Baseline in the hair density at 3 and 6 months
Overview
Brief Summary
The goal of this study was to learn if dietary supplement in capsules and drinkable works to help hair loss in volunteers with chronic telogen effluvium and androgenetic alopecia and learn about its safety. The main questions it aims to answer are:
- Does dietary supplement in capsules and drinkable reduces hair loss in women and men suffering from chronic telogen effluvium or androgenetic alopecia?
- Were the products well accepted by the subjects from their´s perspective? Researchers will compare dietary supplement in capsules and drinkable to a placebo (a look-alike substance that contains no active ingredients) to see if dietary supplements works to reduce hair loss.
Participants will:
- Take assigned diatry supplement in capsule or drinkable or a placebo every day for 6 months
- Visit the study facility once every 3 months for evaulations
- Keep a diary of the product use
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 62 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy female and male subjects, including at least 70% female subjects aged over 30 years old ✓ Caucasian ethnicity
- •Aged between 18 and 62 years old (extreme included)
- •50% of subjects with chronic telogen effluvium (stage from 2 to 4, according to Sinclair scale for female pattern hair loss in women and modified Sinclair scale for female pattern hair loss in men)
- •50% of subjects with androgenetic alopecia (AGA): female subjects Ludwig scale (score I-II) and male subjects Hamilton- Norwood scale (vertex II-III)
- •Subjects aware of the study procedures and having signed an informed consent form
- •Subjects registered with National Health Service (NHS)
- •Subjects certifying the truthfulness of the personal data disclosed to the investigator
- •Subjects able to understand the language used in the investigation and to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements
- •The pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) should be stable for at least one month without any changes expected or planned during the study
- •Commitment not to change the daily routine or the lifestyle
Exclusion Criteria
- •Subjects who do not fit the inclusion criteria.
- •Subjects with acute or chronic diseases able to interfere with the outcome of the study or that are considered dangerous for the subject or incompatible with the study requirements
- •Subjects participating or planning to participate in other clinical trials
- •Subjects deprived of freedom by administrative or legal decision or under guardianship
- •Subjects not able to be contacted in case of emergency
- •Subjects admitted to a health or social facility
- •Subjects planning a hospitalization during the study
- •Subjects who participated in a similar study without respecting an adequate washout period (3 months)
- •Alimentary/Eating disorders (i.e., bulimia, psychogenic eating disorders, etc.)
- •Food allergy or food intolerances
Arms & Interventions
Dietary supplement capsule placebo
Placebo Comparator
Dietary supplement capsule placebo was taken by the subjects daily during 6 months
Intervention: Dietary supplement capsule placebo use for hair loss (Dietary Supplement)
Dietary supplement capsule
Experimental
Dietary supplement capsule was taken by the subjects daily during 6 months
Intervention: Dietary supplement capsule use for hair loss (Dietary Supplement)
Dietary supplement drinkable
Experimental
Dietary supplement drinkable was taken by the subjects daily during 6 months
Intervention: Dietary supplement drinklable use for hair loss (Dietary Supplement)
Dietary supplement drinkable placebo
Placebo Comparator
Dietary supplement drinkable placebo was taken by the subjects daily during 6 months
Intervention: Dietary supplement drinklable placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Change from Baseline in the hair density at 3 and 6 months
Time Frame: From the baseline, at 3 months and at the end of the study (6 months).
Pictures of chosen area of the scalp are taken and the number of hairs per cm2 is counted.
Secondary Outcomes
- Assessment of product acceptability and perceived efficacy at 3 and 6 months(On 3 months and 6 months of product use.)
Investigators
Study Sites (1)
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