Ocular, Periocular and Cutaneous Tolerance and Efficacy of Formula 2039002 10 in Patients With Palpebral Eczema

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.