Efficiency of AgentsNCT06827392
Photoprotection Efficiency with Sunscreen Formulas Under Visible Light Exposure.
An observational study of Efficiency of Agents and Against Pigmentation Induced by Visible Light Exposures, run by Cosmetique Active International at 1 site in France.
Trial summary
To evaluate the protective effect of three Laboratoire VICHY formulations on the pigmentation caused by visible light in comparison to a non-treated control zone in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Efficiency of Agents, Against Pigmentation Induced by Visible Light Exposures
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 6 Sep 2016to 7 Oct 2016
- Phase
- Observational
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adults meeting the inclusion and exclusion criteria and willing to adhere to the protocol and study procedures
Who may be able to join
- Healthy subject of both sexes, aged from 18 to 50 years, of phototype IIIb, IV or V on the Fitzpatrick scale (1988),
- Subject in good health having a normal results at the physical examination and having medical antecedents compatible with the study requirements,
- Woman of childbearing potential using a reliable means of contraception (contraceptive pill, contraceptive implant, IUD, bilateral tubal ligature/section, condoms) and agreeing to not change her method of contraception from one month before the start of the study and for the entire duration of the study,
- Healthy woman of non-childbearing potential, that is post-menopausal (absence of menstrual bleeding for one year prior to screening, hysterectomy or bilateral ovariectomy),
- Subject having signed and dated the informed consent form before any action connected to the study was performed,
- Subject willing and able to follow all the study procedures and complete the whole study,
- Subject affiliated to a social security system (according to French legislation: Law 2004-806 and its implementing decree n°2006-477 of 26 April 2006).
Who cannot join
- Woman who was pregnant or lactating or who planned to become pregnant during the study period,
- Subject having an underlying pathology, or a surgical, physical or medical status which, according to the investigator, could interfere with the interpretation of the study results, such as:
- A history of dermatological problems (e.g. psoriasis, eczema, urticaria..) or a suspicion/history of allergies to cosmetics or adhesives,
- All systemic or local pathologies,
- Skin anomalies (e.g. scars, hirsutism, tattoos…) on the test zones test (middle part of the back),
- Subject having been exposed excessively to ultraviolet light (UV) either natural (sun) or artificial (tanning salon) during the 4 weeks before the screening visit or who planned to expose himself/herself during the study,
Show all 14Show fewer
- Subject having antecedent or current pathologies induced or aggravated by exposure to light or having abnormal reactions to sunlight (e.g. photosensitive dermatitis, polymorphous light eruption, solar urticaria, systemic lupus erythematosus, dermatomyositis),
- Subject having taken a systemic treatment of more than 5 days during the month preceding inclusion (steroids, non-steroidal anti-inflammatories including aspirin, insulin, anti-histamines, anti-hypertensive drugs, antibiotics such as quinolones, tetracyclines, thiazides and fluoroquinolones, and all photosensitising treatments) or any other treatment capable of inducing an abnormal response to UV or visible light (vitamin A derivatives, psoralen, aminolevulinic acid derivatives…) or who planned to take these treatments during the study,
- Subject who had applied a local treatment on the back for more than 2 days during the 2 weeks preceding inclusion (steroids, non-steroidal anti-inflammatories,, anti-histamines, antibiotics) and any cosmetic products in the 24 hours preceding inclusion,
- Subject with clinically significant allergic antecedents, particularly to components of the test products
- Person requiring enhanced protection (person deprived of liberty, minor, placed under guardianship),
- Subject being in a situation which, according to the opinion of the Investigator, would have interfered with an optimal participation in the study
- Subject participating in, or having participated in, another clinical study during the month preceding inclusion,
- Subject unable to communicate effectively with the investigator or not able to follow the study imperatives.
Trial locations and contacts
1 site in 1 country.
France1 site
CPCAD (Centre de Pharmacologie Clinique Appliquée à la Dermatologie)
Nice, 06202
About this study
Official title: Evaluation of the Protective Effect of Three Laboratoire VICHY Formulations on the Pigmentation Induced by Visible Light in Comparison with a Non-treated Control Zone
To evaluate the protective effect of three Laboratoire VICHY formulations on the pigmentation caused by visible light in comparison to a non-treated 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.
- Keywords
- Photoprotection, Sunscreen, Visible Light (VL), Pigmentation
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® between the exposed zone (ZE) and non-exposed zone (ZNE)
Individual Typologic Angle (ITA° - calculated value),
Measured: 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 (4)
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)
Measured: At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4 and Day 5 (24 hours after each Visible Light exposure).
Safety / Local tolerance
Safety was assessed by recording Adverse Events, including cutaneous reactions (local intolerance)
Measured: From the informed consent signature date until the end of the study (Day 5)
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)
Measured: At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4 and Day 5 (24 hours after each Visible Light exposure).
Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)
Erythema (Delta a* - calculated value).
Measured: At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4 and Day 5 (24 hours after each Visible Light exposure).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start6 Sep 2016
- Primary completion7 Oct 2016
- Study completion7 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficiency of AgentsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827392
- Sponsor's protocol ID
- VCA1601
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Protective Effect of Three Laboratoire VICHY Formulations on the Pigmentation Induced by Visible Light in Comparison with a Non-treated Control Zone
- ClinicalTrials.gov ID
- NCT06827392
- Acronym / sponsor ID
- VCA1601
- Keywords
- Photoprotection, Sunscreen, Visible Light (VL), Pigmentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2016 (actual)
- Primary completion
- 7 Oct 2016 (actual)
- Study completion
- 7 Oct 2016 (actual)
- First posted
- 14 Feb 2025 (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 protective effect of three Laboratoire VICHY formulations on the pigmentation caused by visible light in comparison to a non-treated control zone in healthy volunteers
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adults meeting the inclusion and exclusion criteria and willing to adhere to the protocol and study procedures
Key inclusion criteria (7 listed)
- Healthy subject of both sexes, aged from 18 to 50 years, of phototype IIIb, IV or V on the Fitzpatrick scale (1988),
- Subject in good health having a normal results at the physical examination and having medical antecedents compatible with the study requirements,
- Woman of childbearing potential using a reliable means of contraception (contraceptive pill, contraceptive implant, IUD, bilateral tubal ligature/section, condoms) and agreeing to not change her method of contraception from one month before the start of the study and for the entire duration of the study,
- Healthy woman of non-childbearing potential, that is post-menopausal (absence of menstrual bleeding for one year prior to screening, hysterectomy or bilateral ovariectomy),
- Subject having signed and dated the informed consent form before any action connected to the study was performed,
Key exclusion criteria (14 listed)
- Woman who was pregnant or lactating or who planned to become pregnant during the study period,
- Subject having an underlying pathology, or a surgical, physical or medical status which, according to the investigator, could interfere with the interpretation of the study results, such as:
- Subject having been exposed excessively to ultraviolet light (UV) either natural (sun) or artificial (tanning salon) during the 4 weeks before the screening visit or who planned to expose himself/herself during the study,
- Subject having antecedent or current pathologies induced or aggravated by exposure to light or having abnormal reactions to sunlight (e.g. photosensitive dermatitis, polymorphous light eruption, solar urticaria, systemic lupus erythematosus, dermatomyositis),
- Subject having taken a systemic treatment of more than 5 days during the month preceding inclusion (steroids, non-steroidal anti-inflammatories including aspirin, insulin, anti-histamines, anti-hypertensive drugs, antibiotics such as quinolones, tetracyclines, thiazides and fluoroquinolones, and all photosensitising treatments) or any other treatment capable of inducing an abnormal response to UV or visible light (vitamin A derivatives, psoralen, aminolevulinic acid derivatives…) or who planned to take these treatments during the study,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)
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).
Individual Typologic Angle (ITA° - calculated value),
4 secondary outcomes
Clinical investigator's assessment by using clinical scale
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).
Safety / Local tolerance
Time frame: From the informed consent signature date until the end of the study (Day 5)
Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)
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).
Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Efficiency of Agents and Against Pigmentation Induced by Visible Light Exposures, run by Cosmetique Active International at 1 site in France.
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 7 inclusion and 14 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: finished, as of the sponsor's last update on 14 Feb 2025. 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 France. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE) (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).). 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 14 Feb 2025; AzTrials last refreshed its copy on 30 Oct 2026.