Polymorphic Light EruptionNCT05320315
Protective Effect Assessment of Foto Ultra Isdin Solar Allergy Fusion Fluid on the UVA Induced PLE
A study testing Foto Ultra ISDIN® Solar Allergy Fusion Fluid in people with Polymorphic Light Eruption, run by Centre de Pharmacologie Clinique Applique a la Dermatologie at 1 site in France.
Trial summary
The primary objective of this Clinical Investigation was to assess the protective efficacy of a medical device (FOTO ULTRA ISDIN® SOLAR ALLERGY FUSION FLUID) against the polymorphic light eruption induced by the UVA. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polymorphic Light Eruption
- What is being tested?
- Foto Ultra ISDIN® Solar Allergy Fusion Fluid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 25 Feb 2021to 8 Jun 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers of both sexes aged >18 years with a known history of typical PLE on the chest after intense sun exposure and a last PLE outbreak since at least eight months,
- Subject with Phototype I to IV according to the Fitzpatrick classification (1988) (14),
- Subject in good health having normal results for the physical examination and medical antecedents compatible with the study requirements,
- subject of non-childbearing potential (tubal ligation, hysterectomy, bilateral ovariectomy), or, subject of childbearing potential who has been, in the opinion of the Investigator, using an approved method of birth control (e.g. oral contraception pill or patch, intra-uterine devices, contraceptive implants or vaginal rings, condoms, bilateral tubal ligation) for at least 1 month prior to first visit. Subject must agree to continue adequate contraception during the entire study period and for 1 month after the end of the study,
- Subject who, in the Investigator's opinion, will comply with the requirements of the protocol (e.g., follow protocol instructions, maintain regular contact to allow evaluation during the study),
- Subject agreeing to avoid exposure to UV radiation (tanning beds, phototherapy, and sunlight) on the whole body for at least six months before the screening visit and for the whole duration of the study,
- Subject agreeing to not apply cosmetic, medical or aesthetic treatments out of the study protocol on the chest during the whole study duration,
- Healthy subject registered with Social Security in accordance with French law on interventional research. (Law 2004-806 and its implementing decree n°2006-477 of 26 April 2006).
Who cannot join
- Female subject who is pregnant, parturient or breast feeding,
- Subject of childbearing potential having a positive urinary pregnancy test at Day 1,
- Subject has a PLE outbreak in the past eight months,
- Subject has a medical condition or is taking medication that could put him or her at undue risk,
- Subject has a pathology that is unstable or risks interfering with the study,
- Subject is currently receiving treatment that may interfere with interpretation of the study results,
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- Subject has known or suspected allergies or sensitivities to any of the components of the study product,
- Subjects with an underlying pathology, or with a surgical, physical or medical status which, according to the investigator, could interfere with the interpretation of the study results such as:
- Dermatological active pathologies (e.g. acne, psoriasis, eczema, urticaria...) in particular on the tested area (the chest) or suspicion/antecedents of allergies to cosmetics,
- All systemic or local uncontrolled pathologies,
- S kin anomalies (scars, excessive hair, tattooing…) on the chest,
- Subjects having been exposed to ultraviolet radiation (UV), natural (sun) or artificial (tanning salon), in the 6 months before the initial visit or who plans such an exposure during the study,
- Subjects having taken a systemic treatment, able to induce an abnormal response to UV, for more than 5 days during the month preceding inclusion (steroids, non-steroidal anti-inflammatories such as aspirin, insulin, antihistamines, anti-hypertensives, antibiotics such as quinolones, tetracyclines, thiazides and fluoroquinolones, and all other photosensitising treatments) or all treatments capable of inducing an abnormal response to UV (vitamin A derivatives, psoralen, aminolevulinic acid derivatives…) or planning to take these treatments during the study,
- Subjects having applied a local treatment on the chest 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,
- Protected subject as defined in the Articles of the CSP: Article 1121-7: person deprived of liberty by a judicial or administrative decision, or subject to psychiatric care or person admitted to a health or social institution for purposes other than the research. Article 1121-8: adult person subject to a legal protection measure or unable to express his/her consent.
- Subject unable to communicate or cooperate with the Investigator due to poor mental development, language problems or impaired cerebral function,
- Subject currently participating in another clinical study related to pharmaceuticals or MDs or being in an exclusion period of another clinical study,
- Subject who has received (or who will receive) more than 4500 euros as indemnity for participating in clinical studies within the previous 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protective Effect Assessment Foto Ultra Isdin Solar Allergy Fusion Fluid (Isdin, s.a.) on the Ultraviolet A Induced Polymorphic Light Eruption
The primary objective of this Clinical Investigation was to assess the protective efficacy of a medical device (FOTO ULTRA ISDIN® SOLAR ALLERGY FUSION FLUID) against the polymorphic light eruption induced by the UVA.
The secondary objective of this Clinical Investigation was to assess the local safety and the overall tolerability of the test MD on the basis of AE/SAE reporting.
Read the detailed description
This was a PMCF investigation for a MD CE marked and used in its intended purpose with additional procedure non-invasive or non-burdensome.
This was a monocentric, single-blind, randomized, and controlled study performed with intra-individual comparisons. It is a type 2 Interventional study with minimal risks and constraints.
At least Fifteen (15) subjects with a known history of typical PLE on the chest after intense sun exposure were included in the study. The subjects were recruited via the CPCAD Subject Database or from those who spontaneously come to the CPCAD.
At Day 1, the tested MD was applied (2mg/cm²) on on side (10x15cm area) of the chest of each subject. The other side was not treated. Then, 15 minutes after application, both sides were irradiated with 40L/cm² of UVA. Same procedure was used from Day 2 to Day 5 with inceased UVA dose at Day 3 and Day 4 (50J/cm²) and Day 5 (60J/cm²).
UVA exposures have to be stopped once a PLE reaction was induced. Assessments (clinical, colorimetrical and photographs) were performed each day. Last assessments were perfomed at Day 8.
- Conditions
- Polymorphic Light Eruption
- Being tested
- Foto Ultra ISDIN® Solar Allergy Fusion Fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foto Ultra ISDIN® Solar Allergy Fusion FluidDevice
The tested MD is a very high protection sunscreen
| Study group | Role | What they receive |
|---|---|---|
| ACTIVE and UNTREATED | Other | This was an intraindividual comparison study. Active (DM sunscreen) treated zone and Untreated zone are compared Receives: Device: Foto Ultra ISDIN® Solar Allergy Fusion Fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative number of subjects who don't develop a positive PLE reaction
Cumulative number of subjects who don't develop a positive PLE reaction (at Day 8)
Measured: Day 8
Secondary outcomes (2)
Cumulative number of subjects who don't develop a positive PLE reaction by day
Cumulative number of subjects who don't develop a positive PLE reaction by day
Measured: from Day 1 to Day 8
PLE severity score
Scale of severity of polymorphous light eruption, 0 (no PLE) to 3 (severe PLE)
Measured: from Day 1 to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start25 Feb 2021
- Primary completion8 Jun 2021
- Study completion8 Jun 2021
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 Polymorphic Light EruptionStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Monocentric, single-blind, randomized, controlled, study with intra-individual comparisons
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Pharmacologie Clinique Applique a la Dermatologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320315
- Sponsor's protocol ID
- ISD-FT-355-01-2020
- Status last verified
- Apr 2022
- First submitted
- 17 Sep 2021
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make individual participant data (IPD) available to other researchers
Publications
Duteil L, Queille-Roussel C, Aladren S, Bustos X, Trullas C, Granger C, Krutmann J, Passeron T. Prevention of Polymorphic Light Eruption Afforded by a Very High Broad-Spectrum Protection Sunscreen Containing Ectoin. Dermatol Ther (Heidelb). 2022 Jul;12(7):1603-1613. doi: 10.1007/s13555-022-00755-5. Epub 2022 Jun 18.
PubMed 35716331
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effect Assessment Foto Ultra Isdin Solar Allergy Fusion Fluid (Isdin, s.a.) on the Ultraviolet A Induced Polymorphic Light Eruption
- ClinicalTrials.gov ID
- NCT05320315
- Acronym / sponsor ID
- ISD-FT-355-01-2020
- Conditions
- Polymorphic Light Eruption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre de Pharmacologie Clinique Applique a la DermatologieUniversity, hospital or other
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 8 Jun 2021 (actual)
- Study completion
- 8 Jun 2021 (actual)
- First posted
- 11 Apr 2022 (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.
The primary objective of this Clinical Investigation was to assess the protective efficacy of a medical device (FOTO ULTRA ISDIN® SOLAR ALLERGY FUSION FLUID) against the polymorphic light eruption induced by the UVA.
The secondary objective of this Clinical Investigation was to assess the local safety and the overall tolerability of the test MD on the basis of AE/SAE reporting.
Detailed description
This was a PMCF investigation for a MD CE marked and used in its intended purpose with additional procedure non-invasive or non-burdensome.
This was a monocentric, single-blind, randomized, and controlled study performed with intra-individual comparisons. It is a type 2 Interventional study with minimal risks and constraints.
At least Fifteen (15) subjects with a known history of typical PLE on the chest after intense sun exposure were included in the study. The subjects were recruited via the CPCAD Subject Database or from those who spontaneously come to the CPCAD.
At Day 1, the tested MD was applied (2mg/cm²) on on side (10x15cm area) of the chest of each subject. The other side was not treated. Then, 15 minutes after application, both sides were irradiated with 40L/cm² of UVA. Same procedure was used from Day 2 to Day 5 with inceased UVA dose at Day 3 and Day 4 (50J/cm²) and Day 5 (60J/cm²).
UVA exposures have to be stopped once a PLE reaction was induced. Assessments (clinical, colorimetrical and photographs) were performed each day. Last assessments were perfomed at Day 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Monocentric, single-blind, randomized, controlled, study with intra-individual comparisons
| Arm | Type | Receives |
|---|---|---|
| ACTIVE and UNTREATED | Other | Device: Foto Ultra ISDIN® Solar Allergy Fusion FluidThis was an intraindividual comparison study. Active (DM sunscreen) treated zone and Untreated zone are compared |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy volunteers of both sexes aged >18 years with a known history of typical PLE on the chest after intense sun exposure and a last PLE outbreak since at least eight months,
- Subject with Phototype I to IV according to the Fitzpatrick classification (1988) (14),
- Subject in good health having normal results for the physical examination and medical antecedents compatible with the study requirements,
- subject of non-childbearing potential (tubal ligation, hysterectomy, bilateral ovariectomy), or, subject of childbearing potential who has been, in the opinion of the Investigator, using an approved method of birth control (e.g. oral contraception pill or patch, intra-uterine devices, contraceptive implants or vaginal rings, condoms, bilateral tubal ligation) for at least 1 month prior to first visit. Subject must agree to continue adequate contraception during the entire study period and for 1 month after the end of the study,
- Subject who, in the Investigator's opinion, will comply with the requirements of the protocol (e.g., follow protocol instructions, maintain regular contact to allow evaluation during the study),
Key exclusion criteria (18 listed)
- Female subject who is pregnant, parturient or breast feeding,
- Subject of childbearing potential having a positive urinary pregnancy test at Day 1,
- Subject has a PLE outbreak in the past eight months,
- Subject has a medical condition or is taking medication that could put him or her at undue risk,
- Subject has a pathology that is unstable or risks interfering with 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foto Ultra ISDIN® Solar Allergy Fusion FluidThe tested MD is a very high protection sunscreen | Device | ACTIVE and UNTREATED |
Primary outcome
Cumulative number of subjects who don't develop a positive PLE reaction
Time frame: Day 8
Cumulative number of subjects who don't develop a positive PLE reaction (at Day 8)
2 secondary outcomes
Cumulative number of subjects who don't develop a positive PLE reaction by day
Time frame: from Day 1 to Day 8
PLE severity score
Time frame: from Day 1 to Day 8
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 11 Apr 2022.
- Derived from this study: PubMed 35716331Duteil L, Queille-Roussel C, Aladren S, Bustos X, Trullas C, Granger C, Krutmann J, Passeron T. Prevention of Polymorphic Light Eruption Afforded by a Very High Broad-Spectrum Protection Sunscreen Containing Ectoin. Dermatol Ther (Heidelb). 2022 Jul;12(7):1603-1613. doi: 10.1007/s13555-022-00755-5. Epub 2022 Jun 18.
- Individual participant dataSharing planned: No. No plan to make individual participant data (IPD) available to other researchers
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?
A study testing Foto Ultra ISDIN® Solar Allergy Fusion Fluid in people with Polymorphic Light Eruption, run by Centre de Pharmacologie Clinique Applique a la Dermatologie 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 8 inclusion and 18 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 11 Apr 2022. 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?
Cumulative number of subjects who don't develop a positive PLE reaction (time frame: Day 8). 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 NCT05320315, 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 11 Apr 2022.