Performance of [Eyes]™ cream after eyelid surgery

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2010
INTERVENTION: 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, [Eyes]™ on the upper eyelid twice a day for 29 days. The other group will get no treatment. Both groups will have "Codexial Vaseline stérilisée" available to treat any discomfort CONDITION: Condition of skin (colour and elasticity) after eyelid surgery ; Surgery PRIMARY OUTCOME: Colour of the skin around the scar through chromametry at day 1, day 15, day 22, and day 29 SECONDARY OUTCOME: 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 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 soci
Epistemonikos ID: e6503aee734d90962841f6181579c5385a19d720
First added on: Aug 22, 2024