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Status unknownNCT04865055Updated Apr 29, 2021

Photoprotection Efficacy With Sunscreen Formulas Containing the Cyclic Merocyanine Long-UVA Absorber MCE, Under Real Sun Exposure

An interventional study of cyclic merocyanine and placebo in Real Life Pigmentation, sponsored by L'Oreal. Status unknown at 1 site in India. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-29.

Sponsored by L'Oreal · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

To evaluate the photo-protector effect of BC_3 (E212657) formulated in SPF30 compared to SPF30 alone on real sun exposure induced pigmentation in healthy volunteers

Read the detailed description

The study intends to evaluate the clinical efficacy of the photo-protective cosmetic products (758637 10 and 758637 15) and to compare the photo-protection potential of the two products, after its application for 7 days on healthy female volunteers under the normal conditions of use planned by the sponsor. The study will also evaluate the tolerance of the two products on the skin of healthy female volunteers.

The photo-protection is generally concerned with the reduction of exposure to ultra violet radiations, specifically UV-B and UV-A, primarily from the sun. The harmful radiations from the sun can cause various skin issues which can be as minor as skin tanning and as major as skin cancer. The photo-protective products can help in protection of the skin from the harmful sun radiation either by blocking them or absorbing them and preventing the rays to damage the skin

The formula number of both the products are 758637 10 and 758637 15. The SPF value of both the product is 30.

02

Conditions studied

  • Real Life Pigmentation
03

In context

Lead sponsor

L'Oreal is the lead sponsor of 25 studies on the registry; 3 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • The subject is a healthy female volunteer aged between 18-45 years old
  • Subjects with skin phototype IV-V and ITA° 4° to 20°.
  • Subject who has given freely his or her informed consent and who is cooperative and aware of the necessity and duration of the controls so that perfect adherence to the protocol can be expected
  • Subject who is able to read and understand documents transmitted (information sheet and consent form)
  • If the subject is a female of childbearing potential and is willing to use a reliable mean of contraception*(for at least one month before the beginning of the study, and throughout the study) or menopausal women (absence of menstrual periods for one year or more)
  • Accepting to stop the usage of all facial skin cosmetics (lotion, cream, powder, make-up) throughout the study duration.
  • Subject willing to expose / her face and arms to sun for around 1- 2 hours morning and 1-2 hours afternoon during the day

    • sexually active females of childbearing potential should either be surgically sterile (oophorectomy, hysterectomy ortubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant,injection), diaphragm or cervical cap, Intravaginal device, intrauterine device (IUD), condoms.

Exclusion criteria

Exclusion Criteria:

  • Female subject who is pregnant (as demonstrated by positive UPT on screening visit) or planning to get pregnant during the study.
  • Female subjects who are breast-feeding.
  • Subject with a known history or present condition of allergic response to any cosmetic products.
  • Subject with photosensitive dermatosis (sensitive to sun exposure).
  • Subject having skin diseases (e.g. moderate to severe acne vulgaris or nodulocystic acne, psoriasis,naevi, freckles, excess hair, uneven skin tones, vitiligo, active atopic dermatitis, pigmented contact dermatitis or other cutaneous manifestations),on face and upper portion of arms which can interfere with the test readings.
  • Any treatment, topical or systemic, taken in the weeks preceding the screening, which is likely to interfere with the evaluation of the efficacy of the product(s) being studied.
  • Subject undergoing anti-inflammatory, corticoids or retinoids therapy by oral or topical way
  • Subject having used de-pigmenting products, masks exfoliant product on the investigational areas in last 4 weeks.
  • Subject who has been deemed by the investigator as potentially unable or unwilling to comply with the protocol
  • Subject enrolled in another clinical trial during the study period
  • Personnel of the investigational site.
  • Subject with any scar or tatoo on the investigational areas specifically on the face and upper arms
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    cyclic merocyanine

    cyclic merocyanine long-UVA absorber

    Other: cyclic merocyanine

  • Placebo comparator
    placebo

    Other: placebo

Interventions

  • Othercyclic merocyanine

    long-UVA absorber

  • Otherplacebo

    placebo

06

What researchers measure

Primary outcomes

  1. To compare the photo-protective efficacy of two cosmetic investigational products by Clinical scoring done by the study investigator

    color chart

    Time frame: Change from baseline at Day 7

  2. To compare the photo-protective efficacy of two cosmetic investigational products by Non invasive bio-instrumental skin color assessments

    Chromameter

    Time frame: Change from baseline at Day 7

  3. To compare the photo-protective efficacy of two cosmetic investigational products by Self assessment

    questionnaire

    Time frame: Change from baseline at Day 7

Secondary outcomes

  1. To evaluate the tolerance of both the photo protective cosmetic products (A - 758637 10 and B - 758637 15)

    The local intolerances reported by the subjects and observed by the investigator

    Time frame: Change from baseline at Day 7

07

Study locations

1 of 1 sites recruiting
  • CIDP Biotech India Pvt. Lt
    New Delhi, 110016, India
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Csr

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 Apr 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04865055
Lead sponsor
L'Oreal
Responsible party
Sponsor
First posted
Apr 29, 2021
Start date
Apr 29, 2021 (estimated)
Primary completion
Apr 29, 2021 (estimated)
Completion
Apr 29, 2021 (estimated)
Last update
Apr 29, 2021

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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