Condition of skin (colour and elasticity) after eyelid surgery Surgery
Conditions
Interventions
After standard post surgery care (removal of stitches), the upper eyelid will be cleaned with an eye-wash-solution (Ophtaxia) - all patients.
One group will then apply the investigational product, [Ey
Sponsors
Laboratoire Chauvin, Bausch & Lomb Inc. (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Voluntary 2. Caucasian 3. Male or female 4. 18-65 years old 5. Representing all natures of skin 6. Uncomplicated eyelid surgery (excluding canthus): ptosis, aesthetic blepharoplasty, functional blepharoplasty, benign tumour of the upper eyelid or other benign problem with a scar having the length of the ptosis type 7. Followed immediate standard post surgery care: saline solution for cleaning, antiseptic drop, Vitamin A ointment 8. Stitches have been removed more than 24 hours and less than 72 hours previously (stitches removed approx. 7 days after surgery) 9. Not tanned 10. Willing to commit to no sun or artificial U.V. exposure during the entire study period 11. Not using self-tanning lotions on the face 12. Agree to come to the clinical unit with no make-up at all 13. Agree to wash their face with water only when coming to the clinical unit 14. Able to give their written participation consent 15. Affiliated to the social security in accordance to the recommendations of the French law about biomedical research
Exclusion criteria
Exclusion criteria: 1. Scar is not satisfactory 2. History of trauma in study eye 3. History of skin disease inducing a cicatrisation delay 4. Traumatic and complicated eyelid surgery 5. Any progressive pathology requiring the use of topical or systemic anti-inflammatory or anti-infectious agents 6. Insulin dependent diabetes 7. History of intolerance to the investigational product 8. Monocular patients 9. Patients treated with local or systemic anti-inflammatory drugs within 10 days prior to surgery 10. In case of surgery on the second eye, the patient is to be excluded if he was already included for the first study eye 11. Taking part of another study during the study period 12. Cannot commit to the absence of pregnancy and breastfeeding during the study period 13. Significant medical history, including history of medical or psychiatric illness or major surgery, suffering from acute or chronic or progressive illnesses, or presenting a dermatological or ophthalmological pathology likely to interfere with the data of the study 14. Being deprived of his/her freedom 15. Period of exclusion in the national file (VRB: Voluntaires pour la recherche biomédicale) 16. Unwilling to give their written informed consent 17. Not contactable by phone in case of emergency 18. PERITESCO's staff members (Note: PERITESCO is the conducting CRO for this study) 19. Does not fulfil the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Colour of the skin around the scar through chromametry at day 1, day 15, day 22, and day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Main secondary criterion: 1 Elasticity of the skin around the scar with a Cutometer at day 1, 15, 22 and 29 Further sec. criteria: 2. Assessment of the peri-cicatrical skin colour, the surface of the scar and the suppleness of the peri-cicatricail area at day 1, 15, 22 and 29 3. Photograph of the scar for image analysis of its surface at day 1, 15, 22 and 29 4. Photograph of the scar and the eyelid for image analysis of the oedema at day 1, 15, 22 and 29 self-assessment of the peri-cicatricial skin colour, the surface of the scar and the suppleness of the peri-cicatricial area at day 1, 15, 22 and 29 5. Questionnaire about the skin state at day 15, 22 and 29 6. Questionnaire about the investigational product at day 15, 22 and 29 - only for patients receiving the product 7. Dermatological and ophthalmological tolerance follow-up at day 15, 22 and 29 | — |
Countries
France
Outcome results
None listed