Evaluation of a sunscreen product compared with established reference products in outdoor conditions
| ISRCTN | ISRCTN95394014 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95394014 |
| Secondary identifying numbers | ISD-FTP-798-03-2021 |
- Submission date
- 07/07/2022
- Registration date
- 11/08/2022
- Last edited
- 30/09/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims
The aim of this study is to provide evidence of how a new broad-spectrum sunscreen SPF50 performs in outdoor conditions of extreme solar exposure compared with established reference sunscreens established by the International Organization for Standardization in 2019 (ISO 24444:2019).
Who can participate?
Caucasian healthy adult volunteers.
What does the study involve?
The study will take place in an outdoor facility in Mauritius between November 2021 and December 2021. Each participant will receive treatment with the broad-spectrum SPF50 sunscreen (investigational product) and 3 reference ISO products: P3 (SPF15), P5 (SPF30), and P8 (SPF50+). Each of the 4 products will be applied to one of 6 defined areas of the participants' backs, with the remaining 2 areas treated with no sunscreen. The products will all be applied at the same density.
The sunscreen-treated areas will be exposed to the sun for 2 or 3 hours (depending on their baseline skin color). The amount of Ultraviolet A (UVA) and Ultraviolet B (UVB) radiation that participants receive during this time will be measured. Participants' skin will be assessed after 24 hours and after 1 week.
What are the possible benefits and risks of participating?
This study was without direct benefit to the participant. There was a minimum risk predictable to subjects’ health given that the composition of the test products only used known ingredients at safe concentrations. It was however considered that there was still a theoretical possibility of local skin reactions (such as allergic dermatitis or irritant dermatitis) and that sunburn on the test area could not be totally excluded given the high UV indexes. Subjects were instructed to contact the investigator site if any of those reactions occurred and they were followed up until the total resolution of the adverse event. In case of any adverse event after the study period, the subjects were requested to contact the investigator site to be examined by the dermatologist investigator. The study investigator had to follow up on the evolution of the event and determine the relationship to the test product if applicable. The safety of the investigational product had been proved through previous studies as demonstrated in the safety declaration.
Where is the study run from?
ISDIN (Spain)
When is the study starting and how long is it expected to run for?
September 2021 to December 2021
Who is funding the study?
ISDIN (Spain)
Who is the main contact?
Mr Javier Bustos, javier.bustos@isdin.com
Contact information
Public
ISDIN
Provençals 33
08019 Barcelona
Spain
Barcelona
08019
Spain
 ORCID ID |
0000-0001-6892-4814 |
|---|---|
| Phone | +34 932 402 020 |
| javier.bustos@isdin.com |
Study information
| Study design | Double-blinded, single-center, within-subject randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | No participant information sheet available |
| Scientific title | Evaluation of sun protective effect of a sunscreen product under outdoor conditions compared to SPF15, SPF30 and SPF50+. A randomized, double blind, intra-individual, single center clinical study in healthy subjects |
| Study hypothesis | Efficacy of a broad-spectrum SPF 50 sunscreen in comparison with other reference products in outdoor conditions |
| Ethics approval(s) | Approved 11/10/2021, IBL Life Ltd Ethics Committee (4th Floor, IBL House, Caudan Waterfront, 11307, Port Louis, Mauritius; +230 203 2000; iblinfo@iblgroup.com), ref: EC21-COS-067-1 |
| Condition | Sunburn |
| Intervention | On day 1, participants will be assessed using calorimetry to calculate Individual Typology Angle (ITA). Then the investigational product and reference products will be applied to the back of the subjects on randomized defined areas between the scapula and the waist (6 areas per subject). Each area was treated with a different sunscreen: either the investigational product (sunscreen SPF 50), the standard reference products from ISO 24444:2019: P3 (SPF15), P5 (SPF30), and P8 (SPF50+), or no sunscreen (2 areas with no sunscreen, as positive and negative control). Application of the investigational product, as well as standard reference products, on the treated area, was done according to the randomization list. The tested areas were defined as healthy areas on the back. For safety reasons, the non-treated area was not blinded. Products were applied at 2 mg/cm². The comparison will be performed under very high and extreme UV radiations conditions, in an outdoor conditions (at an outdoor facility in Mauritius between November 2021 and December 2021). The exposition time (2-3 h) of each subject corresponded to ITA° with an expected cumulative dose of approximately 100 to 250 mJ/cm² for the treated areas. For each subject the cumulative UVA and UVB doses will be recorded using a radiometer. Participants will be assessed for clinical erythema 24 h (at 20 ±4 h) after exposure, clinical delayed pigmentation 1 week (on day 8 ±1 days) after exposure, and colorimetry performed at both 24 h and 1 week. |
| Intervention type | Other |
| Primary outcome measure | Photoprotective effect measured using an erythema grading scale (grades 0-5) for all investigational areas assessed by a trained evaluator at 24 h |
| Secondary outcome measures | 1. Skin redness measured using a Chromameter CR-400 (Konica Minolta) to record L* (lightness), a* (redness), and ITA° (overall colour) for all investigational areas at baseline, 24 h, and 1 week 2. Skin lightness measured using a Chromameter CR-400 (Konica Minolta) to record L*, a*, and ITA° for all investigational areas at baseline, 24 h and 1 week 3. Evolution of the pigmentation compared to negative control measured using a pigmentation grading scale (grades 0-4) for all investigational areas assessed by a trained evaluator at 1 week 4. Safety and tolerance measured using incidence of adverse events recorded between baseline and 1 week |
| Overall study start date | 23/09/2021 |
| Overall study end date | 31/12/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | Both |
| Target number of participants | 65 |
| Total final enrolment | 65 |
| Participant inclusion criteria | 1. Healthy subjects 2. Caucasian with Individual Typology Angle (ITA) ≥ 28° 2. Aged ≥18 and ≤55 years 3. Uniform skin color of the whole investigational area |
| Participant exclusion criteria | 1. Pregnant or breastfeeding 2. Have used a sunbed or have had intensive sun exposure to the investigational areas within the 3 months before inclusion 3. ITA <28º 4. Tanned or sunburned (erythema) back 5. Dermatological disorders affecting the investigational areas (e.g. presence of multiple nevi, freckles, excess hair or uneven skin tones, tattoo, vitiligo, photo-dermatological disorders) 7. History of abnormal response to sun 8. History of allergy, hypersensitivity, or any serious reaction to any cosmetic product 9. Any concomitant medical condition that the investigator judges may interfere with the study |
| Recruitment start date | 01/11/2021 |
| Recruitment end date | 08/12/2021 |
Locations
Countries of recruitment
- Mauritius
Study participating centre
Sayed Hoseen Road
Phoenix
73408
Mauritius
Sponsor information
Industry
ISDIN
Provençals 33
Barcelona
08019
Spain
| Phone | +34 932 402 020 |
|---|---|
| scientificconsult@isdin.com | |
| Website | www.isdin.com |
"ROR" |
https://ror.org/04dg86p75 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 29/07/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Mr Javier Bustos (Javier.bustos@isdin.com). Individual participant data (in the form of text, tables, figures, and appendices) that underlie the results reported in this article, after deidentification, will be available upon request after publication and ending 36 months after publication. The data sets are stored on spreadsheets and all appropriate requests for appropriate analysis and mechanisms will be considered. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 29/09/2022 | 30/09/2022 | Yes | No |
Editorial Notes
30/09/2022: Publication reference added.
11/07/2022: Trial’s existence confirmed by IBL Life Ltd Ethics Committee.
