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Clinical Study for the Efficacy Evaluation of a Food Supplement

NCT06453837 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2024-06-12

No results posted yet for this study

Summary

The primary aim of this in vivo clinical study is to evaluate the depigmenting effect of an active ingredient incorporated into a food supplement through the evaluation of the melanin variation parameter, assessed with the equipment Antera 3D (Miravex, Ireland), after 28 consecutive days of food supplement's once-daily intake, in comparison with the baseline and a placebo.

The secondary objective of this study is to evaluate in vivo the depigmenting effect of the same active ingredient incorporated into a food supplement through the evaluation of the melanin variation parameter, assessed with the equipment Antera 3D (Miravex, Ireland), after 56 and 84 consecutive days of food supplement's once-daily intake.

Other goals of this clinical study are to evaluate in vivo the effect of the same active ingredient incorporated into a food supplement, after 28, 56 and 84 consecutive days of a once-daily intake, in comparison with the baseline and a placebo (1) on skin whitening/brightening through the evaluation of the L\* parameter, assessed with the equipment Antera 3D (Miravex, Ireland), (2) on the skin colour homogeneity through the measurement of the ITAº (Individual Typology Angle) parameter, assessed with the equipment Colorimeter® CL400, (3) on the skin tone evenness through the measurement of the standard deviation of the skin colour, assessed with the equipment Colorimeter® CL400, (4) on the skin density of the dermis, measured with the equipment Episcan 35 MHz (Longport Inc, United States), (5) on skin hydration assessed through capacitance measurements with the equipment Corneometer® CM825, (6) on the skin firmness, skin overall elasticity and skin total deformation measured with the equipment Cutometer® SEM 575 (Courage+Khazaka electronic GmbH, Germany), and (7) on skin radiance through clinical evaluation performed by an expert.

It is also objective of this clinical study to evaluate (8) subjects' tolerance, acceptability, perception of efficacy and future use/purchase intention towards the food supplements by filling out a subjective evaluation questionnaire after 28, 56 and 84 consecutive days of food supplement's once-daily intake.

Conditions

  • Spot Pigmented
  • Wrinkle

Interventions

OTHER

Mentha Suaveolens extract incorporated into a food supplement

Each subject of this group takes 1 capsule of the food supplement per day, with lunch, for 84 consecutive days.

OTHER

Placebo product

Each subject of this group takes 1 capsule of comparator product per day, with lunch, for 84 consecutive days.

Sponsors & Collaborators

  • Inovapotek, Pharmaceutical Research And Development Lda

    collaborator UNKNOWN

  • Mibelle Group Biochemistry

    lead INDUSTRY

Principal Investigators

  • Marta Ferreira · Inovapotek, Pharmaceutical Research And Development Lda

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-21
Primary Completion
2023-12-21
Completion
2024-03-08

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06453837 on ClinicalTrials.gov