CClinicalTrials.gg
CompletedNCT06796088Updated Jan 28, 2025

Evaluate the Photoprotection Efficiency of Sunscreen Formulas Under Visible Light Exposure

An observational study in Study the Potency of Sunscreen to Protect Against the Pigmentation Induced by Visible Light Exposure on Healthy Back Skin, sponsored by Cosmetique Active International. Completed at 1 site in France. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-28.

Sponsored by Cosmetique Active International · Observational

Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
20
Ages
18 Years to 50 Years
Sex
All
01

Study summary

To evaluate the protective effect of three sunscreens on the pigmentation caused by visible light in comparison to an untreated control zone in healthy volunteers.

Read the detailed description

The sunscreens usually used as photoprotectors are known to protect in the UV domain (UVB and UVA). However, until recently visible light (400-700 nm) was considered as devoid of any photobiological effects on cutaneous tissue. Over the last two decades, with the development of photodynamic therapies and various dermatological treatments using visible laser light, several studies have reconsidered the cutaneous effect of visible light on the skin, in particular the induction of pigmentation.

The aim of this study was to assess the ability of sunscreens with a protective efficacy in the UV domain to prevent the pigmentation induced by Visible Light.

02

Conditions studied

  • Study the Potency of Sunscreen to Protect Against the Pigmentation Induced by Visible Light Exposure on Healthy Back Skin

Keywords

  • Photoprotection
  • Sunscreen
  • Visible Light (VL)
  • Pigmentation
03

In context

Lead sponsor

Cosmetique Active International is the lead sponsor of 54 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Healthy male and female volunteers from 18 to 50 years old, with Phototype III to V according to the Fitzpatrick scale, with a ITA° betwwen -20° and 28° at screening

Inclusion criteria

  1. Healthy subjects of both sexes aged 18 - 50 years old, having a phototype IIIb, IV or V according to Fitzpatrick classification,
  2. Subject with an ITA° (Individual Typologic Angle calculated value) between -20° and 28° at the screening visit,
  3. Healthy subjects based on physical examination and compatibility of medical history with the study content,
  4. Women of childbearing potential using adequate contraception (oral contraception, intra-uterine devices, contraceptive implants or vaginal rings, tubal sections or ligations, condoms) for at least 1 month prior to first visit and agree to continue adequate contraception during the entire duration of the study,
  5. Women of non-childbearing potential (menopausal with one year without bleeding, hysterectomy, bilateral ovariectomy),
  6. Subjects having signed a written informed consent form and dated before any study procedure began.
  7. Subjects willing to actively cooperate during the study duration and willing to complete the study,
  8. Subject affiliated to the social security system (in accordance with the French Law 2004-806 and its implementing decree n°2006-477 of 26 April 2006).

Exclusion criteria

Exclusion Criteria:

  1. Female who was pregnant or breast feeding or planning a pregnancy during the study,
  2. Subject having an underlying known disease, or surgical, physical, or medical condition that, in the opinion of the Investigator could interfere with the interpretation of the clinical trial results such as:

    1. History of recurrent dermatologic conditions (e.g., psoriasis, eczema, urticaria...) or suspicion/history of allergy to cosmetics,
    2. Any systemic or local disease pathology
    3. Skin abnormality (scars, excessive hair, tattoos...) at the level of the test zones (middle part of the back),
  3. Subject who was overexposed to natural (sun) or artificial ultraviolet (tanning lamps) in the last month prior the first visit or who planneda such exposure during the study;
  4. Subject having history or presenting pathologies induced or aggravated by sun exposure or having abnormal reactions to the sun (ex : photosensitive dermatitis, polymorphic light eruption, solar urticaria, systemic erythematous lupus, dermatomyositis),
  5. Subject having taken a systemic treatment more than 5 days in the month preceding the inclusion (steroids, nonsteroidal anti-inflammatory drugs such as aspirin, antihistamine, insulin, hypertensors, antibiotics such as quinolones, tetracyclins, thiazids, fluoroquinolons and photosensitising treatment) or any treatment able to induce abnormal response to UV or visible light (vitamin A derivatives, psoralen, aminolevulinic acid etc.) or having plane to take these treatments during the study,
  6. Subjects having applied a local treatment on the back for more than 2 days during the 2 weeks preceding inclusion (steroids, non-steroidal anti-inflammatories, antihistamines, antibiotics) and all other cosmetic products in the previous 24 hours,
  7. Subject having antecedents of clinically significant allergy, particularly to study product components,
  8. Subjects requiring enhanced protection (deprived of liberty, minors, under guardianship),
  9. Subject being in a situation which, according to the Investigator, could interfere with an optimal participation in the study,
  10. Subject currently participating or having participated in another clinical trial during the month preceding inclusion,
  11. Subject under care of guardian or legal guardianship or subject hospitalized in a medical or social establishment for any reason,
  12. Subject unable to communicate efficiently with the Investigator or being unable to follow the study requirements.
05

Study design

Observational model
Case-only
Time perspective
Other
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • Sunscreen 1

    The test sunscreen 1 was applied (2 mg/cm²) on the attributed zone according to the randomization list. The application was done during 4 consecutive days (From Day 1 to Day 4).

    Other: Treated zones exposed to Visible Light source

  • Sunscreen 2

    The test sunscreen 2 was applied (2 mg/cm²) on the attributed zone according to the randomization list. The application was done during 4 consecutive days (From Day 1 to Day 4).

    Other: Treated zones exposed to Visible Light source

  • Sunscreen 3

    The test sunscreen 3 was applied (2 mg/cm²) on the attributed zone according to the randomization list. The application was done during 4 consecutive days (From Day 1 to Day 4).

    Other: Treated zones exposed to Visible Light source

  • Untreated zone

    non-treated control zone

    Other: Untreated zone exposed to Visible Light source

Interventions

  • OtherTreated zones exposed to Visible Light source

    The treated zones were exposed to Visible Light to induce skin pigmentation (144J/cm2), 15 to 30 minutes after application.

  • OtherUntreated zone exposed to Visible Light source

    The untreated zone was exposed to Visible Light to induce skin pigmentation (144J/cm2), as the same time as the treated zones.

06

What researchers measure

Primary outcomes

  1. Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)

    Individual Typologic Angle (ITA° - calculated value)

    Time frame: At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4 and Day 5 (24 hours after each Visible Light exposure).

Secondary outcomes

  1. Clinical investigator's assessment by using clinical scale

    Visual scoring of pigmentation, using a pigmentation 11-point scale with 0 (No pigmentation), 1 (Doubtful), 2 (Very pale brown -), 3 (Very pale brown), 4 (Very pale brown +), 5 (Pale brown -), 6 (Pale brown), 7 (Pale brown +), 8 (Brown -), 9 (Brown), 10 (Brown +) Visual scoring of erythema, using an erythema 4-point scale with 0 (Absent), 0.5 (Doubtful), 1 (Weak but well-defined erythema), 2 (Moderate), 3 (Severe)

    Time frame: At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4, Day 5 (24 hours after each Visible Light exposure) and at Day 12..

  2. Safety / Local Tolerance

    To assess the local tolerance and the overall tolerability of the test products on the basis of undesirable effect reporting and on subjective symptoms (dryness, pruritus and burning sensation) assessed on 5-point scale from 0-4: No symptom (0); Minimal symptoms (1); Mild symptoms (2); Moderate symptoms (3); Severe symptoms (4)

    Time frame: From the informed consent signature date (Screening visit) until the end of the study (Day 12).

  3. Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)

    Pigmentation (Delta E, Delta L\* and Delta b\* - calculated values)

    Time frame: At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4 and Day 5 (24 hours after each Visible Light exposure).

  4. Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)

    Erythema (Delta a\* calculated values)

    Time frame: At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4 and Day 5 (24 hours after each Visible Light exposure).

07

Study locations

1 site
  • CPCAD (Centre de Pharmacologie Clinique Appliquée à la Dermatologie)
    Nice, 06202, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06796088
Lead sponsor
Cosmetique Active International
Responsible party
Sponsor
First posted
Jan 28, 2025
Start date
Sep 23, 2020
Primary completion
Oct 29, 2020
Completion
Oct 29, 2020
Last update
Jan 28, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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