PigmentationNCT04865094
Photoprotection Efficacy With Sunscreen Formulas Containing the Cyclic Merocyanine Long-UVA Absorber MCE Under Long-UVA Exposure
A study testing cyclic merocyanine in people with Pigmentation and Redness, run by L'Oreal at 1 site in Romania.
Trial summary
To evaluate the photo-protector effect of BC_3 (E212657) formulated in SPF compared to SPF alone on long-UVA induced pigmentation in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pigmentation, Redness
- 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 siteRomania
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female or male volunteer;
- from 18 to 40 years old;
- uniform skin color all over on the investigational zones;
- skin type III or IV according to the Fitzpatrick classification;
- ITA° between 10° and 35° at screening visit with an authorize delta of ± 2° at inclusion visit (D1) (Individual Typologic Angle calculated value);
- female of childbearing age using a reliable mean of contraception (for at least three month before the beginning of the study, and throughout the study);
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- informed about the study objectives and procedures, and able to understand them;
- willing and able to fulfill the study requirements and schedule.
- All subjects will have to give their written informed consent
Who cannot join
- Female in pregnancy (positive pregnancy-test performed before inclusion) or lactation or without effective contraception ;
- having planned U.V. exposure of the investigational zones (sunlight or sunbeds) throughout the study;
- having used sunbed or sun exposure of the investigational zones within the 3 months before inclusion;
- having sunburn (erythema) on the back;
- dermatological disorders affecting the investigational zones (presence of naevi, freckles, excess hair or uneven skin tones, vitiligo, photo-dermatological problems);
- history of skin cancer;
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- history of abnormal response to sun;
- presence of recent suntan (according to Investigator opinion) or photo-test marks;
- history of allergy, hypersensitivity, or any serious reaction to any cosmetic product;
- any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator;
- having used within the month before inclusion any systemic medication for more than 5 consecutive days (e.g. steroidal and non-steroidal anti-inflammatory drugs, insulin, antihistamines, antihypertensive, antibiotics -e.g. quinolone, tetracycline, thiazides, fluoroquinolones-), or any medication known to cause abnormal responses to U.V. exposure (e.g. vitamin A derivatives, psoralen, aminolevulinic acid derivatives, etc.), or having planned to use these medications during the study;
- having used within the 3 months before inclusion any depigmenting / whitening or propigmenting topical treatments, or any systemic treatment that would interfere with the study assessments (anti-inflammatory drugs, corticoids, retinoids, hydroquinone, etc.);
- unable to be contacted by phone in case of emergency;
- having participated within the 30 days before inclusion or currently participating in another clinical study.
- Deprived of liberty by adjunction or by official decision.
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
CIDP Biotechnology
Bucharest, 011607
Alina GHITA, pHD, 0 317 181 ext. 182 / 183, AlinaNanu@eurofins.com
About this study
Official title: A Monocenter, Double-blind, Comparative, Controlled, Randomized Study to Evaluate the Effect of E212657 Compared to Placebo on Long UVA Induced Pigmentation in Healthy Volunteers.
To evaluate the photo-protector effect of BC_3 (E212657) formulated in SPF compared to SPF alone on long-UVA induced pigmentation in healthy volunteers.
Read the detailed description
The sun emits numerous radiations, of which 10% are constituted by ultraviolet light. Only ultraviolet B (UVB, 280-320 nm) and ultraviolet A (UVA, 320-400 nm) reach the surface of the earth. Poor penetrating UVB reach only to the deepest layers of the epidermis and cause DNA damage. UVA rays pass through the epidermis and reach the dermis due to their greater penetration property. UVA mainly generate intracellular oxidative stress. We can distinguish short UVA (320-340 nm) and long UVA (340-400 nm).
Sun exposure causes short-term consequences such as sunburn and reflects a reaction erythema, inflammatory type, and stimulation of pigmentation. One of the long-term deleterious consequences is represented by the development of skin cancers, which are the most dramatic result of sun exposure and are associated with mutations resulting from DNA damage badly repaired. The other long-term consequence is illustrated by the clinical signs of photoaging, associated with a major disruption in the dermal structure, linked both the decrease in collagen content and an increase in its degradation by some enzymes in the family of MMPs (matrix metalloproteinases). At the cellular and molecular level, many genes have their basal expression modulated in response to UV exposure (transcription factors and genes involved in DNA repair, inflammation, apoptosis, cell adhesion). Chronic sun exposure is also associated with the development or aggravation of pigmentary disorders, zones of hypo- or hyperpigmentation, actinic lentigo, melasma.
To protect ourselves from harmful effects of sun exposure, solar formulas applied to the skin, constitute a "barrier" against UV radiation. Currently, the most efficient sunscreen formulas from the market can absorb very efficiently and most of UVB and UVA rays. However, a part of long UVA (370-400nm) is not absorbed by these formulas, while these wavelengths seem to be involved in the generation of adverse biological effects on the skin, which may participate in clinical consequences of sun exposure, such as photo-aging and carcinogenesis. Biologically these wavelengths have been found to induce alteration at the tissue level, in particular the dermal layer, but also at the cellular and molecular levels, with for example the generation of oxidative stress and DNA damage.
Internal in vitro studies on skin cells in culture or on reconstructed skin showed that long UVA were the generators of oxidative stress, damage to DNA, cytotoxicity and modulation of genes or proteins involved in inflammation, the response to oxidative stress or photo-aging.
New sunscreens that are able to absorb beyond 370 nm, are now available. We have shown in an in vitro cultured cells or reconstructed skin that adding this type of filter in a state of the art formulation, allowed to shift the absorption spectrum beyond 370 nm and more. Thus it is possible to significantly reduce the biological impact of UVA long. These in vitro results strongly suggest a gain of biological protection by shifting the spectrum absorption beyond 370 nm.
The purpose of this clinical proof of concept study is to demonstrate that the addition of the Merocyanine BC_3 (E212657), a new long UVA filter, in a reference formula improves protection against a long UVA exposure in vivo in human. Safety studies have demonstrated that BC_3 (E212657) is a safe product (Non phototoxic, non irritant, non sensitizer, non photosensitizer and non Genotoxic). In vitro studies have shown versus reference a photo-protector effect on fibroblast, MMP1 and Cytokines after an 60J/cm² exposure.
- Conditions
- Pigmentation, Redness
- Being tested
- cyclic merocyanine, placebo
- Medical subject headings
- Erythema
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 | 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.
Biophysical non-invasive assessment of skin color by using Chromameter Post-UVA pigmentation, Erythema
Delta E calculated value \& ITA°-calculated value, a* value
Measured: Change from baseline at Day 7
Clinical investigator's assessment by using clinical scale
Visual scoring of pigmentation
Measured: Change from baseline at Day 7
Secondary outcomes (1)
Safety was assessed by recording Adverse Events, including cutaneous reactions (local intolerance)
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Investigators
- ALINA GHITA, PhD, Study director, CIDP Biotechnology S.R.L
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865094
- Sponsor's protocol ID
- ACR-LUVA2-1394
- 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
Publications
Marionnet C, de Dormael R, Marat X, Roudot A, Gizard J, Planel E, Tornier C, Golebiewski C, Bastien P, Candau D, Bernerd F. Sunscreens with the New MCE Filter Cover the Whole UV Spectrum: Improved UVA1 Photoprotection In Vitro and in a Randomized Controlled Trial. JID Innov. 2021 Nov 25;2(1):100070. doi: 10.1016/j.xjidi.2021.100070. eCollection 2022 Jan.
PubMed 35072138
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
- A Monocenter, Double-blind, Comparative, Controlled, Randomized Study to Evaluate the Effect of E212657 Compared to Placebo on Long UVA Induced Pigmentation in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT04865094
- Acronym / sponsor ID
- ACR-LUVA2-1394
- Conditions
- Pigmentation, Redness
- 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 SPF compared to SPF alone on long-UVA induced pigmentation in healthy volunteers.
Detailed description
The sun emits numerous radiations, of which 10% are constituted by ultraviolet light. Only ultraviolet B (UVB, 280-320 nm) and ultraviolet A (UVA, 320-400 nm) reach the surface of the earth. Poor penetrating UVB reach only to the deepest layers of the epidermis and cause DNA damage. UVA rays pass through the epidermis and reach the dermis due to their greater penetration property. UVA mainly generate intracellular oxidative stress. We can distinguish short UVA (320-340 nm) and long UVA (340-400 nm).
Sun exposure causes short-term consequences such as sunburn and reflects a reaction erythema, inflammatory type, and stimulation of pigmentation. One of the long-term deleterious consequences is represented by the development of skin cancers, which are the most dramatic result of sun exposure and are associated with mutations resulting from DNA damage badly repaired. The other long-term consequence is illustrated by the clinical signs of photoaging, associated with a major disruption in the dermal structure, linked both the decrease in collagen content and an increase in its degradation by some enzymes in the family of MMPs (matrix metalloproteinases). At the cellular and molecular level, many genes have their basal expression modulated in response to UV exposure (transcription factors and genes involved in DNA repair, inflammation, apoptosis, cell adhesion). Chronic sun exposure is also associated with the development or aggravation of pigmentary disorders, zones of hypo- or hyperpigmentation, actinic lentigo, melasma.
To protect ourselves from harmful effects of sun exposure, solar formulas applied to the skin, constitute a "barrier" against UV radiation. Currently, the most efficient sunscreen formulas from the market can absorb very efficiently and most of UVB and UVA rays. However, a part of long UVA (370-400nm) is not absorbed by these formulas, while these wavelengths seem to be involved in the generation of adverse biological effects on the skin, which may participate in clinical consequences of sun exposure, such as photo-aging and carcinogenesis. Biologically these wavelengths have been found to induce alteration at the tissue level, in particular the dermal layer, but also at the cellular and molecular levels, with for example the generation of oxidative stress and DNA damage.
Internal in vitro studies on skin cells in culture or on reconstructed skin showed that long UVA were the generators of oxidative stress, damage to DNA, cytotoxicity and modulation of genes or proteins involved in inflammation, the response to oxidative stress or photo-aging.
New sunscreens that are able to absorb beyond 370 nm, are now available. We have shown in an in vitro cultured cells or reconstructed skin that adding this type of filter in a state of the art formulation, allowed to shift the absorption spectrum beyond 370 nm and more. Thus it is possible to significantly reduce the biological impact of UVA long. These in vitro results strongly suggest a gain of biological protection by shifting the spectrum absorption beyond 370 nm.
The purpose of this clinical proof of concept study is to demonstrate that the addition of the Merocyanine BC_3 (E212657), a new long UVA filter, in a reference formula improves protection against a long UVA exposure in vivo in human. Safety studies have demonstrated that BC_3 (E212657) is a safe product (Non phototoxic, non irritant, non sensitizer, non photosensitizer and non Genotoxic). In vitro studies have shown versus reference a photo-protector effect on fibroblast, MMP1 and Cytokines after an 60J/cm² exposure.
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 merocyaninelong-UVA absorber |
| placebo | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy female or male volunteer;
- from 18 to 40 years old;
- uniform skin color all over on the investigational zones;
- skin type III or IV according to the Fitzpatrick classification;
- ITA° between 10° and 35° at screening visit with an authorize delta of ± 2° at inclusion visit (D1) (Individual Typologic Angle calculated value);
Key exclusion criteria (15 listed)
- Female in pregnancy (positive pregnancy-test performed before inclusion) or lactation or without effective contraception ;
- having planned U.V. exposure of the investigational zones (sunlight or sunbeds) throughout the study;
- having used sunbed or sun exposure of the investigational zones within the 3 months before inclusion;
- having sunburn (erythema) on the back;
- dermatological disorders affecting the investigational zones (presence of naevi, freckles, excess hair or uneven skin tones, vitiligo, photo-dermatological problems);
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
Biophysical non-invasive assessment of skin color by using Chromameter Post-UVA pigmentation, Erythema
Time frame: Change from baseline at Day 7
Delta E calculated value \& ITA°-calculated value, a* value
Clinical investigator's assessment by using clinical scale
Time frame: Change from baseline at Day 7
Visual scoring of pigmentation
1 secondary outcome
Safety was assessed by recording Adverse Events, including cutaneous reactions (local intolerance)
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.
- Derived from this study: PubMed 35072138Marionnet C, de Dormael R, Marat X, Roudot A, Gizard J, Planel E, Tornier C, Golebiewski C, Bastien P, Candau D, Bernerd F. Sunscreens with the New MCE Filter Cover the Whole UV Spectrum: Improved UVA1 Photoprotection In Vitro and in a Randomized Controlled Trial. JID Innov. 2021 Nov 25;2(1):100070. doi: 10.1016/j.xjidi.2021.100070. eCollection 2022 Jan.
- Individual participant dataSharing planned: Yes
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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.
ALINA GHITA, PhD study director
CIDP Biotechnology S.R.L
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 Pigmentation and Redness, run by L'Oreal at 1 site in Romania.
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 9 inclusion and 15 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 Romania. 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?
Contact ALINA GHITA, PhD (0 317 181 ext. 182 / 183, AlinaNanu@eurofins.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biophysical non-invasive assessment of skin color by using Chromameter Post-UVA pigmentation, Erythema (time frame: Change from baseline at Day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04865094, which also lists 1 linked publication.
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.