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5-fluorouracil Versus Placebo in Periocular Full Thickness Skin Grafts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02705352
Recruitment Status : Completed
First Posted : March 10, 2016
Results First Posted : February 25, 2020
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Michael Yoon, Massachusetts Eye and Ear Infirmary

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Ectropion
Skin Neoplasms
Interventions Drug: 5-Fluorouracil
Other: Normal saline
Enrollment 1
Recruitment Details Challenges recruiting patients into the study.
Pre-assignment Details  
Arm/Group Title 5-Fluorouracil Normal Saline
Hide Arm/Group Description

Antimetabolite will be injected 2 weeks after periocular reconstruction with full thickness skin graft. Injection will be repeated every 2 weeks for a total of up to 4 injections.

5-Fluorouracil: Treatment medication

Normal saline will be injected 2 weeks after periocular reconstruction with full thickness skin graft. Injection will be repeated every 2 weeks for a total of up to 4 injections.

Normal saline: Placebo

Period Title: Overall Study
Started 1 0
Completed 1 0
Not Completed 0 0
Arm/Group Title 5-Fluorouracil Normal Saline Total
Hide Arm/Group Description

Antimetabolite will be injected 2 weeks after periocular reconstruction with full thickness skin graft. Injection will be repeated every 2 weeks for a total of up to 4 injections.

5-Fluorouracil: Treatment medication

Normal saline will be injected 2 weeks after periocular reconstruction with full thickness skin graft. Injection will be repeated every 2 weeks for a total of up to 4 injections.

Normal saline: Placebo

Total of all reporting groups
Overall Number of Baseline Participants 1 0 1
Hide Baseline Analysis Population Description
Unable to recruit patients into the study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
<=18 years
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
>=65 years
1
 100.0%
1
 100.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 0 participants 1 participants
72  (0) 72  (0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
Female
0
   0.0%
0
   0.0%
Male
1
 100.0%
1
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
White
1
 100.0%
1
 100.0%
More than one race
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 0 participants 1 participants
1 1
Scar appearance   [1] 
Measure Type: Number
Unit of measure:  Units on a scale
Number Analyzed 1 participants 0 participants 1 participants
1 1
[1]
Measure Description: Patient and Observer Scar Assessment Scale (POSAS). The POSASv2.0 consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically on a ten-step scale (one is most normal, 10 is worst scar imaginable). Together they make up the ‘Total Score’ of the Patient and Observer Scale. Furthermore category boxes are available to score nominal parameters (e.g. type of colour). Moreover, the patient and observer also score their ‘Overall Opinion’. Total and subscales are averaged.
1.Primary Outcome
Title Graft Size Change
Hide Description Full thickness skin grafts will be measured prior to treatment (at time of surgery) and 12 months after surgery. Although the graft will be measured at each visit, the outcome is the final size at 12 months.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
One white male in study group
Arm/Group Title 5-Fluorouracil Normal Saline
Hide Arm/Group Description:

Antimetabolite will be injected 2 weeks after periocular reconstruction with full thickness skin graft. Injection will be repeated every 2 weeks for a total of up to 4 injections.

5-Fluorouracil: Treatment medication

Normal saline will be injected 2 weeks after periocular reconstruction with full thickness skin graft. Injection will be repeated every 2 weeks for a total of up to 4 injections.

Normal saline: Placebo

Overall Number of Participants Analyzed 1 0
Measure Type: Number
Unit of Measure: percent change in graft
10
2.Secondary Outcome
Title Adverse Events
Hide Description Treatment side effects will be recorded. Examples include pain, skin thinning, color/texture change, atrophy, telangiectasis, infection, and erythema.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Unable to recruit more study patients.
Arm/Group Title 5-Fluorouracil Normal Saline
Hide Arm/Group Description:

Antimetabolite will be injected 2 weeks after periocular reconstruction with full thickness skin graft. Injection will be repeated every 2 weeks for a total of up to 4 injections.

5-Fluorouracil: Treatment medication

Normal saline will be injected 2 weeks after periocular reconstruction with full thickness skin graft. Injection will be repeated every 2 weeks for a total of up to 4 injections.

Normal saline: Placebo

Overall Number of Participants Analyzed 1 0
Measure Type: Number
Unit of Measure: Events
0
3.Secondary Outcome
Title Early Post-operative Complications
Hide Description Surgery complications will be recorded, not related to treatment. Examples are wound dehiscence, graft necrosis, infection, bleeding, partial/complete graft failure and/or ectropion.
Time Frame 2 weeks after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Unable to recruit more study patients.
Arm/Group Title 5-Fluorouracil Normal Saline
Hide Arm/Group Description:

Antimetabolite will be injected 2 weeks after periocular reconstruction with full thickness skin graft. Injection will be repeated every 2 weeks for a total of up to 4 injections.

5-Fluorouracil: Treatment medication

Normal saline will be injected 2 weeks after periocular reconstruction with full thickness skin graft. Injection will be repeated every 2 weeks for a total of up to 4 injections.

Normal saline: Placebo

Overall Number of Participants Analyzed 1 0
Measure Type: Number
Unit of Measure: Number of events
0
4.Secondary Outcome
Title Surgeon and Patient Satisfaction
Hide Description Patient and Observer Scar Assessment Scale (POSAS). The POSASv2.0 consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically on a ten-step scale (one is most normal, 10 is worst scar imaginable). Together they make up the 'Total Score' of the Patient and Observer Scale. Furthermore category boxes are available to score nominal parameters (e.g. type of colour). Moreover, the patient and observer also score their 'Overall Opinion'. Total and subscales are averaged.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Unable to recruit more patients.
Arm/Group Title 5-Fluorouracil Normal Saline
Hide Arm/Group Description:

Antimetabolite will be injected 2 weeks after periocular reconstruction with full thickness skin graft. Injection will be repeated every 2 weeks for a total of up to 4 injections.

5-Fluorouracil: Treatment medication

Normal saline will be injected 2 weeks after periocular reconstruction with full thickness skin graft. Injection will be repeated every 2 weeks for a total of up to 4 injections.

Normal saline: Placebo

Overall Number of Participants Analyzed 1 0
Measure Type: Number
Unit of Measure: score on a scale
1
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 5-Fluorouracil Normal Saline
Hide Arm/Group Description

Antimetabolite will be injected 2 weeks after periocular reconstruction with full thickness skin graft. Injection will be repeated every 2 weeks for a total of up to 4 injections.

5-Fluorouracil: Treatment medication

Normal saline will be injected 2 weeks after periocular reconstruction with full thickness skin graft. Injection will be repeated every 2 weeks for a total of up to 4 injections.

Normal saline: Placebo

All-Cause Mortality
5-Fluorouracil Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
Hide Serious Adverse Events
5-Fluorouracil Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
5-Fluorouracil Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Shyana Harper
Organization: Massachusetts Eye and Ear
Phone: 6173915982
EMail: Shyana_harper@meei.harvard.edu
Layout table for additonal information
Responsible Party: Michael Yoon, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT02705352    
Other Study ID Numbers: 786680-1
First Submitted: February 22, 2016
First Posted: March 10, 2016
Results First Submitted: January 24, 2020
Results First Posted: February 25, 2020
Last Update Posted: February 25, 2020