Antiageing and anti-cellulite efficacy of a food supplement
- Conditions
- Fine lines/light wrinkles, dull skin and uneven skin tone and mild to moderate cellulite-derived skin imperfectionsSkin and Connective Tissue Diseases
- Registration Number
- ISRCTN36901382
- Lead Sponsor
- ROELMI HPC
- Brief Summary
2023 Results article in https://www.yumedtext.com/files/publish/published-pdf--6-ACED-150.pdf (added 18/12/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 66
1. Healthy female subjects
2. Age between 35 and 65 (extremes included) years old
3. Phototype I to IV included, according to Fitzpatrick classification
4. Subjects showing fine lines/light wrinkles, dull skin and uneven skin tone
5. Subjects showing mild to moderate cellulite-derived skin imperfections
6. 10 subjects per group showing visible dark circles
7. 10 subjects per group showing visible eyebags
8. Subjects who have not been involved in any other similar in the last 3 months
9. Subjects registered with Nation Health Service (NHS),
10. Subjects certifying the truthfulness of the personal data disclosed to the investigator
11. Subjects able to understand the language used in the investigation center and the information given by the investigator
12. Subjects able to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements
13. 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
14. Commitment not to change the daily routine or the lifestyle
15. Subjects who have not been recently involved in any other similar study
16. Subjects having signed their written Informed Consent form (ICF) for their participation in the study and a photograph authorization
1. Subject does not meet the inclusion criteria
2. 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
3. Subjects participating or planning to participate in other clinical trials
4. Subjects deprived of freedom by administrative or legal decision or under guardianship
5. Subjects not able to be contacted in case of emergency
6. Subjects admitted to a health or social facility
7. Subjects planning a hospitalization during the study
8. Subjects who participated in a similar study without respecting an adequate washout period
9. Subjects having an acute, chronic or progressive illness liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
10. Subjects under pharmacological treatments that are considered incompatible with the study requirement by the investigator
11. 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
12. Subjects that have shown allergies or sensitivity to cosmetic products, drugs, patch or medical devices
13. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Evaluation of face skin profilometry (wrinkledness and eyebags volume) and thighs skin profilometry (smoothness), measured using Primos 3D (GFMesstechnik GmbH) at T0, T28, T56 (days).<br>2. Evaluation of cellulite-induced alteration of skin microcirculation by means of a thermal camera (FLIR infrared camera – FLIR Systems AB) at T0, T28, T56.
- Secondary Outcome Measures
Name Time Method 1. Epidermis moisturization (500µm) by means of the MoistureMeterEpiD at T0, T28, T56 (days).<br>2. Skin brightness by means of a spectrophotometer/colorimeter CM-700D (Konica Minolta, Milan, Italy) at T0, T28, T56.<br>3. Dark circle color by means of a spectrophotometer/colorimeter CM-700D (Konica Minolta, Milan, Italy) at T0, T28, T56.<br>4. Face digital pictures acquired by means of Visioface device (Courage+Khazaka) and cellulite affected zones pictures taken using a reflex digital camera at T0, T28, T56.<br>5. Body circumferences measurement at level of: thigh, waistline and hips at T0, T28, T56.<br>6. Clinical evaluations of face skin evenness, pinkish, eyebags and dark circles appearance and of Orange peel” skin appearance (thighs) carried out by the experimenter according to clinical and photographic scales at T0, T28, T56.<br>7. Product acceptability and volunteers’ perceived efficacy assessed by self-assessment questionnaire at T28 and T56.