Instrumental evaluation of the photo-protective and antiageing efficacy of a food supplement
| ISRCTN | ISRCTN18121679 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18121679 |
| Secondary identifying numbers | E.HU.016-0030.01.005L |
- Submission date
- 01/10/2019
- Registration date
- 03/10/2019
- Last edited
- 12/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
The objective of this study was to evaluate the efficacy and tolerance of SUN ISDIN in reducing the susceptibility to UVR exposure (erythema response of skin and lipoperoxides) and in improving ageing signs
Who can participate?
Subjects between 40 and 65 years old, showing clinical ageing sings and at least one dark spot on the face
What does the study involve?
Participants will take one capsule once a day in the morning: the capsule must be taken whole with plenty of liquid during the entire study. Skin condition will be assessed in a clinical assessment at baseline and after14, 28, 56 and 84 days product use
What are the possible benefits and risks of participating?
Benefits associated with product use and study participation are related to photo-protection action and improvement of skin appearance. During the study is possible that subjects would note a decrease in ageing signs.
The potential risks associated with the use of the product are related to both subjective and objective adverse events (AEs) (e.g. bloating, diarrhea, stomach ache). The occurrence of AEs related to individual susceptibility to specific ingredients in the product could be related to a biological phenomenon that is not avoidable. Potential risks are assumed to be from mild to moderate and are not expected to pose a risk to human health. Risks associated with the procedures involved in this study are judged as minor. All the measurements carried out are not invasive and no skin side effects are expected from the measurement process except for MED assessment. An erythema reaction is foreseen for the MED assessment procedure but, usually, this reaction disappears in a short time period and sometimes to a mild hyperpigmentation
Where is the study run from?
Complife Italia Srl, San Martino Siccomario, Italy
When is the study starting and how long is it expected to run for?
October 2018 for three months
Who is funding the study?
ISDIN S.A.
Who is the main contact?
Javier Bustos
Clinical Affairs Manager
javier.bustos@isdin.com
Contact information
Public
ISDIN S.A.
Provençals 33
Barcelona
08019
Spain
| Phone | +34 (0)932402020 |
|---|---|
| javier.bustos@isdin.com |
Study information
| Study design | Monocentric prospective open-label study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Clinical-instrumental assessment of the sun protection and antiageing efficacy of a food supplement |
| Study objectives | SUNISDIN CAPSULES contains a combination of natural actives such as vitamins, carotenoids, selenium, green tea extract, Vitis Vinifera L. and Polypodium Leucotomos extract. The pool of vitamins such as Vitamin C, Vitamin E, Vitamin A together with Lutein, Green tea extract and Lycopene helps to fight free radicals reducing oxidative stress and support healthy cell bioenergetics and mitochondria function. |
| Ethics approval(s) | Approved 05/09/2018, Comitato Etico Indipendente per le Indagini Cliniche Non Farmacologiche (Via XX Settembre 30/4-16121 Genova, Italy; +39 (0)10 5454842; ssinf@messaggipec.it), ref: 2018/10 |
| Health condition(s) or problem(s) studied | Antiaging and photoprotection |
| Intervention | One SUN ISDIN capsule is taken once a day in the morning: the capsules must be taken whole with plenty of liquid. Capsules are taken for 12 weeks. |
| Intervention type | Supplement |
| Primary outcome measure | Photo-protective and antioxidant efficacy after 12 weeks use: 1. Skin moisturization 2. Skin radiance 3. Skin elasticity 4. Subjective evaluation 5. Tolerability |
| Secondary outcome measures | Skin condition assessed as above at baseline and after14, 28, 56 and 84 days use |
| Overall study start date | 01/05/2018 |
| Completion date | 15/05/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 30 |
| Key inclusion criteria | 1. Healthy female and male subjects (without any specific repartition) 2. Caucasian ethnicity 3. Phototype from I to III according to Fitzpatrick classification 4. Age between 40 and 65 years old 5. Showing clinical ageing signs 6. Showing at least one dark spot on face |
| Key exclusion criteria | 1. Pregnant or breastfeeding women 2. Allergies or sensitivity to cosmetic products, toiletries, sunscreens, and/or topical drugs 3. Dermatological problems in the test area 4. Pharmacological treatments (both locally or systemically) known to interfere with the test product 5. Used self-tanning products for at least one month before study start |
| Date of first enrolment | 02/10/2018 |
| Date of final enrolment | 12/01/2019 |
Locations
Countries of recruitment
- Italy
Study participating centre
San Martino Siccomario
27028
Italy
Sponsor information
Industry
Provençals 33
Barcelona
08019
Spain
| Phone | +34 (0)932402020 |
|---|---|
| javier.bustos@isdin.com | |
"ROR" |
https://ror.org/04dg86p75 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 10/10/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | The researchers intend to publish the study results in an international peer-reviewed indexed scientific journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. Written informed consent from participants was obtained. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2020 | 12/05/2020 | Yes | No |
Editorial Notes
12/05/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
04/10/2019: The ethics approval contact details were added.
03/10/2019: Trial’s existence confirmed by Comitato Etico Indipendente per le Indagini Cliniche Non Farmacologiche
