Evaluation of the Dietary Supplement Efficacy Against Hair Loss in Subjects Suffering From Hair Loss

Lacer S.A.

Status: Completed

Conditions: Androgenetic Alopecia (AGA); Chronic Telogen Effluvium

Treatments: Dietary Supplement: Dietary supplement capsule use for hair loss; Dietary Supplement: Dietary supplement capsule placebo use for hair loss; Dietary Supplement: Dietary supplement drinklable placebo; Dietary Supplement: Dietary supplement drinklable use for hair loss

Study type: Interventional

Funder types: Industry

Identifiers

NCT07358403

IT0006736/24

Details and patient eligibility

About

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

Enrollment: 240 patients

Sex: All

Ages: 18 to 62 years old

Volunteers: Accepts Healthy Volunteers

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
• Subject informed about the study procedures and having signed the privacy policy

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
• Impaired immune system due to i-mmunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications
• Subjects who have any type of gastrointestinal disease or disorders (Chrons disease, colitis, irritable bowel syndrome, intestinal malabsorption)
• Pharmacological treatment (topic or systemic) known to interfere with the tested product or having effect on metabolism (e.g.: anticoagulants, antidepressants, drugs used to lower cholesterol levels, antiviral drugs and beta-blockers)
• Subjects having frequent stomach burn
• Cosmetic treatment known to interfere with the tested product (e.g.: anti-hair loss shampoo, antihair loss food supplements, anti-hair loss serum) during the study and in the last 3 months before study start
• Subjects who intends to carry out any straightening, permanent or other treatments on hair (hair botox,etc)
• Subjects with drandruff, seborrheic dermatitis or any other hair condition
• Subjects having a skin disease or condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
• Subjects that have shown allergies or sensitivity to cosmetic products, drugs, patch or medical devices
• Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 4 patient groups, including a placebo group

Dietary supplement capsule

Experimental group

Description:

Dietary supplement capsule was taken by the subjects daily during 6 months

Treatment:

Dietary Supplement: Dietary supplement capsule use for hair loss

Dietary supplement capsule placebo

Placebo Comparator group

Description:

Dietary supplement capsule placebo was taken by the subjects daily during 6 months

Treatment:

Dietary Supplement: Dietary supplement capsule placebo use for hair loss

Dietary supplement drinkable

Experimental group

Description:

Dietary supplement drinkable was taken by the subjects daily during 6 months

Treatment:

Dietary Supplement: Dietary supplement drinklable use for hair loss

Dietary supplement drinkable placebo

Placebo Comparator group

Description:

Dietary supplement drinkable placebo was taken by the subjects daily during 6 months

Treatment:

Dietary Supplement: Dietary supplement drinklable placebo