Evaluation of the Dietary Supplement Effect on Improvement of Hair Condition in Subjects With Occasional Hair Loss.
Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Tolerability of an Oral Dietary Supplement for Occasional Telogen Effluvium in Adult Men and Women.
1 other identifier
interventional
60
1 country
1
Brief Summary
The goal of this study is to learn if dietary supplement works to help with improving hair condition in subjects with occasional hair loss. It will also learn about its safety. The main question it aims to answer is:
- Does the dietary supplement reduce the number of hair lost by participants? Researchers will compare dietary supplement to a placebo (a look-alike substance that contains no drug) to see if it works to reduce hair loss. Participants will:
- Take dietary supplement or a placebo every day for 3 months
- Visit the clinic every month for evaluations
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2026
CompletedFirst Posted
Study publicly available on registry
September 23, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
September 23, 2026
September 1, 2026
4 months
September 17, 2026
September 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in the number of shed hairs at 3 Months
Hair loss will be evaluated by wash and combing test
From enrollment to the end of treatment at 3 months
Study Arms (2)
Dietary supplement capsule
EXPERIMENTALPlacebo capsule
PLACEBO COMPARATORInterventions
Dietary supplement will be taken daily for 2 months
Eligibility Criteria
You may qualify if:
- Men and women aged 18 to 70 years.
- Self-perceived occasional telogen effluvium, with a count of 100 or more shed hairs in the standardized wash and combing test, confirmed at the screening visit (Visit 0), of recent onset (less than 6 months) and attributable to factors such as stress, nutritional deficiency, pollution, or seasonality.
- Good general health, in the investigator's judgment, with no relevant uncontrolled systemic disease.
- Availability and willingness to attend the three study visits and comply with study procedures over a 90-day period.
- Agreement to receive study-related communications electronically (email and/or SMS), where expressly authorized.
- Ability to understand the study and provide written informed consent.
You may not qualify if:
- Refusal to provide informed consent to participate in the study.
- Inability to understand the study language.
- Pregnancy or breastfeeding.
- Established androgenetic alopecia (Hamilton-Norwood classification or other pattern hair loss disorders) or other forms of alopecia (alopecia areata, scarring alopecia, trichotillomania, or others) diagnosed or suspected by the investigator.
- Use of specific pharmacological or cosmetic treatments for hair loss (minoxidil, finasteride, topical or systemic corticosteroids, other dietary supplements, or hair lotions) within the 3 months prior to enrollment.
- Uncontrolled endocrine disease (e.g., thyroid disorders), diagnosed severe nutritional deficiency, untreated anemia, or a recent history (\< 6 months) of severe febrile illness, major surgery, or childbirth.
- Active scalp dermatological conditions (psoriasis, moderate-to-severe seborrheic dermatitis, fungal or bacterial infections) that may interfere with clinical assessment or instrumental evaluation techniques.
- Any disease, treatment, or characteristic that, in the investigator's opinion, may preclude participation due to unnecessary risk or interference with the study and/or interpretation of the results, particularly:
- Use of aspirin or related compounds, antibiotics, anti-inflammatory drugs, corticosteroids, antidepressants, antihistamines, or immunosuppressive treatments.
- Ongoing allergen desensitization therapy (allergy immunotherapy).
- Presence of dermatological abnormalities in the study area, such as irritation, erythema, scars, pigmentation disorders, numerous freckles, or nevi.
- History of intolerance or allergy to medications or other substances that may pose an unjustified risk.
- Use of a nutricosmetic supplement within the 3 months prior to study initiation or during the entire study period.
- History of intolerance or allergy to cosmetic products of the same type as the investigational product.
- Receipt of a vaccination within the previous month or planned vaccination during the study period.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lacer S.A.lead
Study Sites (1)
Cosmocare
Barcelona, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2026
First Posted
September 23, 2026
Study Start
October 1, 2026
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
September 23, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share
Only data included in the publication will be shared.