Clinical trial NCT05540496: Ocular, Periocular and Cutaneous Tolerance and Efficacy of Formula 2039002 10 in Patients With Palpebral Eczema
Official title: Ocular, Periocular and Cutaneous Tolerance and Efficacy of Formula 2039002 10 Product in Patients With Palpebral Eczema During 4 Weeks Under Dermatological and Ophthalmological Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eczema Eyelid
Keywords: palpebral eczema
ocular
periocular
Lead sponsor: Cosmetique Active International
Sponsor class: INDUSTRY
First posted: 2022-09-14
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: participants with palpebral eczema meeting the inclusion and exclusion criteria and agreeing with the study constraints

Brief summary: The eyelids are particularly susceptible to eczema. Eyelid eczemas also called palpebral eczema, are a common condition that causes the skin on or around the eyelid to become dry, itchy, and irritated.

The study aims at evaluating the ocular and peri-ocular tolerance and the efficacy of the investigational product under normal conditions of use in participants with a palpebral eczema ground.

This open-labeled, multicentric study was conducted under dermatological and ophthalmological control in Caucasian subjects over 18 years of age, of all skin types and having a sensitive skin, especially on eye contour. The investigational product was to be applied twice daily on eyes contour for 4 weeks.

Detailed description: The evaluation of the investigational product in participants with a palpebral eczema ground has been conducted under dermatological and ophthalmological control by Dermatech.

The study was conducted in the spirit of the French and European Guidelines for Good Clinical Practice, the recommendations of the International Conference on Harmonization (ICH) and according to the Helsinki Declaration in its latest version (Seoul 2008) and the General Data Protection Regulation (GDPR).

A 35-patient panel is considered as enough size to reach study objectives. The following statistical analysis are performed after data control and randomisation released.

* Excluded data: In case of incoherent /aberrant value, it could be decided to exclude the data from the analysis (a justification will be brought).
* Protocol deviation: All deviations from the protocol are listed. Deviations that may have an impact on the study results are identified.
* Initial characteristics: The initial characteristics of the patients will be summarized using descriptive statistics (means, minimum and maximum values for quantitative variables, absolute and relative frequencies for qualitative variables).
* Clinical assessment and self-assessment scales:

  * Calculation of mean and standard deviation at each time point at Day0 Time0 (D0T0), Day0 Time10 minutes (D0T10min), D14 and Day28 Time0 (D28T0) for the clinical assessment and at D0T0, D14 and D28T0 for the self-assessment scales.
  * Evaluation of time effect using a linear mixed effect model, with time (at D0T0, D0T10min, D14 and D28T0 for the clinical assessment and at D0T0, D14 and D28T0 for the self-assessment scales) as a fixed effect, and patients as a random effect to take into account that several measurements were performed on each patient.
  * In case of significance of the time effect, multiple comparisons among timepoints will be performed with Tukey adjustment). In case of non-convergence of the linear mixed effect model, a logistic mixed effect model could be performed as an alternative, where modalities would be grouped into two modalities (presence/absence of sign).
* Questionnaire of cosmetic acceptability: Calculation of effective and percentages of positive answers.
* Quality of life questionnaires: Qualitative variables will be summarized by effective and percentages. Quantitative variables will be summarized by mean and standard deviation, median and quartiles, and range.
* Safety analysis: Interpretation of safety data was performed by analyzing each reaction, attributable to the application of study product (reactions reported by patient in the daily log questionnaire and reactions reported by investigator during examination). The investigator gives his conclusion on the investigational product cutaneous acceptability.

Regarding the participants, the reasons for which a participant can be discontinued from the study or withdrawn from the data analysis, are:

* Withdrawal of the participant's consent (possible at any time and for whatever reason): in this case, the data collected for the study up to the date of the withdrawal will be analyzed unless patient express opposition. Patient agreement will be sought by the investigator or the study responsible for the use of routine follow-up data that could be collected after withdrawal of consent.
* Lost to follow up: in this case, the investigator or the study responsible will make an effort to contact the participant and determine the reason (at least 2 calls reported in the Case Report Form (CRF)).
* Emergence of a non-inclusion criterion.
* Investigator or study responsible decision (for example but not limited to: the investigator or study responsible believes for safety reasons or in the best interest of the participant that he/she had to stop its study participating).
* Protocol violation. The reason(s) of participant premature release will be sought and documented by the investigator or the study responsible in the appropriate pages of the CRF.

Regarding the investigational product, expected reactions after application of this type of cosmetic product are slight to very slight and not persistent discomfort or irritation reaction and are not considered as adverse events (AE). All adverse events will be investigated and evaluated from the informed consent form signature date for the study last visit date.

If such an adverse event is on-going at the final visit, the investigator will follow the event until complete resolution or stabilization.

Eligibility criteria: Inclusion Criteria:

* caucasian
* phototype I to IV
* palpebral eczema ground (blepharitis, epiphora, chronic whimpering/watery eyes)
* sensitive skin and especially on eye contour
* all skin types of eyes contours
* not tanned on the face (no sun or artificial U.V. exposure for at least a month)
* no exfoliation, scrubbing or peeling of the whole face for at least 2 weeks

Exclusion Criteria:

* at least one ocular functional sign at inclusion day
* receiving a medication which, in the investigator's judgment, places the patient at undue risk
* an intra-ocular surgery within the 6 months preceding the beginning of the study
* an ocular laser session, within the month preceding the beginning of the study

Primary outcomes:
measure: change in clinical assessment of efficacy items
timeFrame: change from baseline to Day28 Time0
Secondary outcomes:
measure: change in dermatological evaluation of the tolerance - functional signs
timeFrame: change from baseline to Day28 Time10minutes
measure: change in dermatological evaluation of the tolerance - clinical signs
timeFrame: change from baseline to Day28 Time10minutes
measure: change in ophthalmological evaluation of the tolerance - functional signs
timeFrame: change from baseline to Day28 Time10minutes
measure: change in ophthalmological evaluation of the tolerance - physical signs
timeFrame: change from baseline to Day28 Time10minutes
measure: change in self-assessment of efficacy items
timeFrame: change from baseline to Day28 Time0
measure: change in quality of life
timeFrame: change from baseline to Day28 Time0
measure: change in sensitivity and quality of life of patients
timeFrame: change from baseline to Day28 Time0
measure: cutaneous acceptability and efficacy
timeFrame: Day28 Time0
measure: global acceptability of the ocular and peri-ocular area
timeFrame: Day28
Other outcomes:
Locations:
city: Batumi
country: Georgia
facility: LTD Health
city: Kutaisi
country: Georgia
facility: LTD Kutaisi Primary Health Care centre #1
Study officials:
affiliation: Dermatech
name: Meryem Nili
role: STUDY_DIRECTOR
References: