Condition category
Surgery
Date applied
25/02/2010
Date assigned
25/03/2010
Last edited
25/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Olivier Galatoire

ORCID ID

Contact details

Péritesco
4
rue Villédo
Paris
75001
France

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

Sponsor information

Organisation

Laboratoire Chauvin, Bausch & Lomb Inc. (France)

Sponsor details

416
rue Samuel Morse
Montpellier Cedex 2
34961
France

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes