Evaluating a food supplement for improving skin and hair conditions
Biometrical Evaluation of the Efficacy of a Food Supplement Versus Placebo
This study is testing whether a food supplement can improve skin and hair conditions in people over two months compared to a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 45 Years to 65 Years |
| Sex | Female |
| Sponsor | Finzelberg GmbH & Co. KG Industry-sponsored |
| Locations | 1 site (Gdansk, GDANSK) |
| Trial ID | NCT06727292 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy of a food supplement compared to a placebo in enhancing skin physiological parameters over a 2-month period. Participants will take either the supplement or placebo daily and will visit the study center at the start, after 28 days, and after 56 days for evaluations. They will also maintain a diary to track their skin status and tolerability. The study is designed as a double-blind, randomized pilot study conducted at a single center.
Who should consider this trial
Good fit: Ideal candidates are non-smoking individuals with normal to dry skin, aged between 18 and 33 BMI, and without any significant skin conditions.
Not a fit: Patients with existing skin pathologies or those currently using medications that may interact with the study product may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a nutritional approach to improve skin and hair conditions for patients.
How similar studies have performed: While similar studies have explored nutritional supplementation for skin health, this specific approach is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Phototype: I to IV;
* Subjects with normal to dry skin;
* Subjects with healthy skin on the study area;
* Non-smokers;
* Has normal nutritional habits (not vegetarian/vegan);
* Is not pregnant or lactating;
* Has a BMI of 18 - 33 kg/m2;
* Is willing to refrain from taking dietary supplements (at best not at all, in any case not during the last month before study start);
* Willing not to use any oral products or any nutritional supplementation aiming at improving skin status during the course of the study;
* No history of malabsorption diseases, liver diseases, or diseases of the lipid metabolism;
* Uses no medication, which may interact with the study product
Exclusion Criteria:
* For women: pregnant or nursing woman or woman planning to get pregnant during the study;
* Cutaneous pathology on the study zone (eczema, etc.);
* Subject with make-up on the day of the visit at the laboratory;
* Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the efficacy of the study product:
* change in anti-wrinkle, smoothing and/or firming topical products within previous week on the studied zones,
* non-invasive procedures within previous month on the studied zones,
* intake of food supplement acting on skin within the three previous months,
* invasive procedures:
* deep chemical peeling within previous 3 months on the studied zones,
* mesotherapy, dermapen, laser within previous 6 months on the studied zones,
* botox and/or hyaluronic acid injections within previous 12 months on the studied zones;
* Intake of vitamin substances and diets comprising a change of normal eating habits;
* Known allergy to one or several investigational product´s ingredients;
* Participation in a nutritional study within the last 30 days;
* Surgical or internal diseases e.g. a metabolic or endocrine disease that may affect the outcome of the study (e.g. diabetes, liver diseases, kidney disorders) or having a history of medical or surgical events that may significantly affect the study outcome including any cardiovascular disease, skin disease, hypertension (\>140/90 mm Hg in three repeated measurements).
Where this trial is running
Gdansk, GDANSK
- Eurofins Dermscan Poland — Gdansk, Gdansk, Poland (Recruiting)
Study contacts
- Study coordinator: Cynthia G Suarez, PhD
- Email: cynthia.suarez-rizzo@finzelberg.com
- Phone: 004916098144462
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.