Real Life PigmentationNCT04865055
Photoprotection Efficacy With Sunscreen Formulas Containing the Cyclic Merocyanine Long-UVA Absorber MCE, Under Real Sun Exposure
A study testing cyclic merocyanine in people with Real Life Pigmentation, run by L'Oreal at 1 site in India.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Real Life Pigmentation
- What is being tested?
- cyclic merocyanine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 29 Apr 2021to 29 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
CIDP Biotech India Pvt. Lt
New Delhi, 110016
Payal GUPTA, MD, +91 11 4079 3385 ext. 3385, info@cidp-cro.com
About this study
Official title: Clinical Evaluation of the Photo-protective Efficacy of a Sunscreen (FLA No: 758637 10 and 758637 15) Product in Healthy Adults Volunteers for 7 Days
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.
- Conditions
- Real Life Pigmentation
- Being tested
- cyclic merocyanine, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclic merocyanineOther
long-UVA absorber
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| cyclic merocyanine | Active comparator | cyclic merocyanine long-UVA absorber Receives: Other: cyclic merocyanine |
| placebo | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the photo-protective efficacy of two cosmetic investigational products by Clinical scoring done by the study investigator
color chart
Measured: Change from baseline at Day 7
To compare the photo-protective efficacy of two cosmetic investigational products by Non invasive bio-instrumental skin color assessments
Chromameter
Measured: Change from baseline at Day 7
To compare the photo-protective efficacy of two cosmetic investigational products by Self assessment
questionnaire
Measured: 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
Measured: Change from baseline at Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start29 Apr 2021 (estimated)
- Primary completion29 Apr 2021 (estimated)
- Study completion29 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Real Life PigmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- L'Oreal
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865055
- Sponsor's protocol ID
- 14CSI044
- Status last verified
- Apr 2021
- First submitted
- 26 Apr 2021
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Photo-protective Efficacy of a Sunscreen (FLA No: 758637 10 and 758637 15) Product in Healthy Adults Volunteers for 7 Days
- ClinicalTrials.gov ID
- NCT04865055
- Acronym / sponsor ID
- 14CSI044
- Conditions
- Real Life Pigmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- L'OrealIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2021 (estimated)
- Primary completion
- 29 Apr 2021 (estimated)
- Study completion
- 29 Apr 2021 (estimated)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cyclic merocyanine | Active comparator | Other: cyclic merocyaninecyclic merocyanine long-UVA absorber |
| placebo | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cyclic merocyaninelong-UVA absorber | Other | cyclic merocyanine |
| placeboplacebo | Other | placebo |
Primary outcome
To compare the photo-protective efficacy of two cosmetic investigational products by Clinical scoring done by the study investigator
Time frame: Change from baseline at Day 7
color chart
To compare the photo-protective efficacy of two cosmetic investigational products by Non invasive bio-instrumental skin color assessments
Time frame: Change from baseline at Day 7
Chromameter
To compare the photo-protective efficacy of two cosmetic investigational products by Self assessment
Time frame: Change from baseline at Day 7
questionnaire
1 secondary outcome
To evaluate the tolerance of both the photo protective cosmetic products (A - 758637 10 and B - 758637 15)
Time frame: Change from baseline at Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cyclic merocyanine in people with Real Life Pigmentation, run by L'Oreal at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the photo-protective efficacy of two cosmetic investigational products by Clinical scoring done by the study investigator (time frame: Change from baseline at Day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021; AzTrials last refreshed its copy on 6 Nov 2026.