Condition category
Skin and Connective Tissue Diseases
Date applied
01/10/2019
Date assigned
03/10/2019
Last edited
04/10/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes

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