Performance of [Eyes]™ cream after eyelid surgery
| ISRCTN | ISRCTN15031227 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15031227 |
| Secondary identifying numbers | 538 |
- Submission date
- 25/02/2010
- Registration date
- 25/03/2010
- Last edited
- 25/03/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Olivier Galatoire
Scientific
Scientific
Péritesco
4, rue Villédo
Paris
75001
France
Study information
| Study design | Single centre open label randomised controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | Randomised, parallel, open study of the in vivo performance of [Eyes]™ restructuring and regenerating cream in the follow-up care after standard post surgery care in uncomplicated eyelid surgery |
| Study acronym | EYES |
| Study objectives | Evaluation of the effect of the restructuring and regenerating cream of the brand [Eyes]™ applied following the standard care and after removal of the stitches and complete wound closure in uncomplicated eyelid surgery, on skin colour. |
| Ethics approval(s) | Approval received from the local ethics committee (Comité de Protection des Personnes Ile de France VIII; Hôpital Ambroise Paré-9) on the 23rd of November 2007 (ref: 07 10 61) |
| Health condition(s) or problem(s) studied | Condition of skin (colour and elasticity) after eyelid surgery |
| 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 |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Colour of the skin around the scar through chromametry at day 1, day 15, day 22, and day 29 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/01/2008 |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 30/06/2008 |
Locations
Countries of recruitment
- France
Study participating centre
Péritesco,
Paris
75001
France
75001
France
Sponsor information
Laboratoire Chauvin, Bausch & Lomb Inc. (France)
Industry
Industry
416, rue Samuel Morse
Montpellier Cedex 2
34961
France
"ROR" |
https://ror.org/018qejt38 |
|---|
Funders
Funder type
Industry
Laboratoire Chauvin, Bausch & Lomb Inc. (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
