Plain English Summary
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
Trial website
Contact information
Type
Public
Primary contact
Mr Javier Bustos
ORCID ID
Contact details
ISDIN S.A.
Provençals 33
Barcelona
08019
Spain
+34 (0)932402020
javier.bustos@isdin.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
E.HU.016-0030.01.005L
Study information
Scientific title
Clinical-instrumental assessment of the sun protection and antiageing efficacy of a food supplement
Acronym
Study hypothesis
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
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
Study design
Monocentric prospective open-label study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
01/05/2018
Overall trial end date
15/05/2019
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
30
Participant 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
Recruitment start date
02/10/2018
Recruitment end date
12/01/2019
Locations
Countries of recruitment
Italy
Trial participating centre
Complife Italia S.r.l
Via Angelini, 21
San Martino Siccomario
27028
Italy
Sponsor information
Organisation
ISDIN S.A.
Sponsor details
Provençals 33
Barcelona
08019
Spain
+34 (0)932402020
javier.bustos@isdin.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
ISDIN S.A.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The researchers intend to publish the study results in an international peer-reviewed indexed scientific journal.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.
Written informed consent from participants was obtained.
Intention to publish date
10/10/2019
Participant level data
Other
Basic results (scientific)
Publication list