Evaluation of a sunscreen product compared with established reference products in outdoor conditions

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN95394014

Enrollment

Registered

2022-08-11

Start date

2021-11-01

Completion date

Unknown

Last updated

2022-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sunburn Skin and Connective Tissue Diseases

Interventions

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 subje

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Photoprotective effect measured using an erythema grading scale (grades 0-5) for all investigational areas assessed by a trained evaluator at 24 h	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Mauritius

Contacts

Public ContactJavier Bustos

javier.bustos@isdin.com+34 932 402 020

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 13, 2026