A Prospective, Randomized, Partially Double-blinded, Placebo and Active-controlled, Parallel, Multiple-dose, Matched-pairs, Single-center Phase 2 Clinical Trial to Explore Efficacy and Safety of Topical Application of EG-Decorin to Skin Graft Donor Site in Patients with Wound

Not Applicable

Conditions: Diseases of the skin and subcutaneous tissue

Registration Number: KCT0003467

Lead Sponsor: Eyegene

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

1) arbitrary participation informed consent volunteer
2) 19~75 years when screening
3) the patient who need skin graft because of trauma, ulcer, burns, surgery incision defect
4) the patient who can give the following the skin graft donor site
(1) location: both sides leg similar location or ipsilateral(if ipsilateral donor site, the maxium distance= 3cm) leg skin graft
donor site
(2) 0.008~0.012 inch (0.20~0.30mm) split-thickness skin grafts (STSG)
(3) if the following size was content with criteria:
? 2 skin graft donor site areas are similar(permission within 25% difference)
? 2 skin graft donor site areas 38~127cm2(25% difference consideration)
(4) if the skin graft donor site which the previous skin graft donor site didn't give

Exclusion Criteria

1) active systemic infection or over 38? fever lasted 3 days within 1 week before inject investigaional product
2) the severity of disease excluded diabetes(immune deficiency syndrom, arteriosclerosis obliterans, variceal) could be influenced wound recovery
3) the patient who couldn't regulate blood sugar of HbA1c= 8.5% or severe diabetes complication
4) B or C type hepatitis patient(exclusion healthy carrier) or evidence of HIV(Human Immunodeficiency Virus)
5) thyroid cancer(stage I, II papillary, follicular, medullary types), basal cell or squamous cell carcinoma not metastasize in skin, CIN and CIS of cervix, other site malignancy tumor medical history within 3 years excluded intraepithelial carcinoma
6) hypersensitivity reaction anamnesis
7) the patient didn't progress the fix period received the prohibited drug or therapy before clinical trial
8) the patient who injecting the comcomitant prohibied drugs
9) creatinine > 1.5 x ULN(upper limit of Normal)
10) ALT >3 x ULN(upper limit of Normal)
11) Total bilirubin > 3 x ULN(upper limit of Normal)
12) Plasma Albumin < 2g/dL
13) INR
(1) if the patient are not injecting anticoagulant, prothrombin time/international normalized ratio (PT INR) > 1.5 x UNL(upper limit of Normal)
(2) the patient is relevant to the following category as the patient are injecting anticoagulant(e.g. warfarin or LMW heparin)
? active bleeding or hemorrhage inclination highly (e.g.: anamnesis aneurysm patient)
? target INR(2~3) couldn't maintain although injection the stable dose
14) smoker didn't stop smoking within clinical trial
15) the anamnesis patient who drink and other drug abuse before screening 6 months
16) the patient who contingently have the injection experience of psychotropic substances, narcotic analgesics before
screening 6 months
17) the psychosis or other central nerve patient who couldn't proceed the clinical trial by investigator judgment
18) communication impossible patient
19) the patient who have low understanding clinical trial or no willingness to visit or already scheduled elective surgery
by investigator judgement
20) pregnant woman or no willingness to stop breast-feeding
21) Not included the following criteria(in other words, the patient can participate if the following are relevent)
(1) menopause(non-therapy-induced amenorrhea over 12 months) woman
(2) infertility because of surgery(ovary or have no uterus) woman
(3) if man who have no any semen after man-infertility surgery have sexual relationship only one partner
(4) if pregnancy could be woman, woman who use the effective contraception as below.
? oral contraception
? contraception patch
? intrauterine device(IUD)
? contraception implant
? contraception injection(controlled-relaese)
? uterus hormone device
? tubal ligation and infertility surgery
(5) woman who agreed the abstinence within clinical trial
? the experience which the patient definitely have abstinence during all period
? excluded the intermittent abstinence(e.g.: ovulation, symptothermal, after ovulation) or external ejaculation
22) the patient who participate present participating or within 30 days after previous participation
23) other unsuitable cases by investigator judgement

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
100% re-epithelialization or not and lead time in experimental product and comparator by investigator judgement

Secondary Outcome Measures

Name	Time	Method
re-epithelialization area ratio(%) injected in experimental product and comparator;re-epithelialization velocity(re-epithelialization area(%)/ lead time(day));50% re-epithelialization lead time(day);100% re-epithelialization or not by investigator judgement;100% re-epithelialization or not by judging the photos in skin graft donor site;blister formation or breakdown occurrence patient ratio after 100% re-epithelialization;exudate occurence frequency and ratio in injected experimental product and comparator;exudate occurence aspect in injected experimental product and comparator