Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
538
Study information
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
Acronym
EYES
Study hypothesis
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
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)
Study design
Single centre open label randomised controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Phase IV
Drug names
Primary outcome measures
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 trial start date
01/01/2008
Overall trial end date
30/06/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
01/01/2008
Recruitment end date
30/06/2008
Locations
Countries of recruitment
France
Trial participating centre
Péritesco,
Paris
75001
France
Funders
Funder type
Industry
Funder name
Laboratoire Chauvin, Bausch & Lomb Inc. (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary