Juvidex (Mannose-6-Phosphate) in Accelerating the Healing of Split Thickness Skin Graft Donor Sites

NCT00664352 | Completed Phase 1

• 1 other identifier: RN1004-0082
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare the efficacy of two concentrations of Juvidex with placebo on the healing of split thickness skin graft donor sites

Conditions

Wound

Keywords

Double blind; Placebo controlled; wound healing

Outcome Measures

Primary Outcomes (1)

• The time to complete wound closure as assessed by the investigating physician

  Measured up to Day 28

Secondary Outcomes (1)

• Local wound tolerability

  Up to Day 28 after surgery

Study Arms (5)

1

EXPERIMENTAL

Drug: Mannose-6-Phosphate (Juvidex)

2

EXPERIMENTAL

Drug: Mannose-6-Phosphate (Juvidex)

3

EXPERIMENTAL

Drug: Mannose-6-Phosphate (Juvidex)

4

EXPERIMENTAL

Drug: Mannose-6-Phophate (Juvidex)

5

OTHER

Drug: Placebo

Interventions

Mannose-6-Phosphate (Juvidex) DRUG

* 100µL of 300mM (8.46 mg/100μL) Juvidex will be injected intradermally into each cm2 of one 3cm2 donor site and into the 0.5cm border around the donor site no more than 20 minutes before graft harvest (total dose 750µL). A further 300µL of 300mM (8.46 mg/100μL) Juvidex will be applied topically within 30 minutes of graft harvest and 24 hours after graft harvest. * 100µL of placebo will be injected intradermally into each cm2 of the other 3cm2 donor site and into the 0.5cm border around the donor site no more than 20 minutes before graft harvest (total dose 750µL). A further 300µL of placebo will be applied topically within 30 minutes of graft harvest and 24 hours after graft harvest.

1

Mannose-6-Phophate (Juvidex) DRUG

* 300µL of 600mM (16.93 mg/100μL) Juvidex will be applied topically to one 3cm2 donor site within 30 minutes of graft harvest and 24 hours after graft harvest. * 300µL of placebo will be applied topically to the other 3cm2 donor site within 30 minutes of graft harvest and 24 hours after graft harvest.

4

Placebo DRUG

* 100µL of placebo will be injected intradermally into each cm2 of one 3cm2 donor site and into the 0.5cm border around the donor site no more than 20 minutes before graft harvest (total dose 750µL). A further 300µL of placebo will be applied topically within 30 minutes of graft harvest and 24 hours after graft harvest. * Standard Care (moist wound healing dressings alone) will be applied to the other 3cm2 donor site.

5

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged 18-85 years who have given written informed consent.
• A body mass index between 18-35 calculated using Quetelets index-weight (kg)/height² (m).
• Subjects with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests and ECG as specified in the trial protocol (see Protocol Section 6.4.2). All laboratory tests must be performed within 28 days of the first trial dose administration.
• Female patients of child bearing potential who are using a highly effective method(s) of contraception and agree to do so from at least the screening visit until one month after administration of the final study dose. For the purposes of the protocol, highly effective method(s) of contraception will be defined as consistently and correctly used implants, injectables, combined oral contraceptives, sexual abstinence or a vasectomised partner

You may not qualify if:

• Subjects who on direct questioning and physical examination have history or evidence of hypertrophic or keloid scarring.
• Subjects with tattoos, birthmarks, moles or previous scars within 3cm of the area to be investigated during the trial.
• Afro-Caribbean subjects are excluded because of the increased susceptibility to hypertrophic and keloid scarring.
• Subjects who have had surgery in the area to be investigated within one year of the first dosing day.
• Subjects with a skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial.
• Subjects with any clinically significant medical condition or history of any condition that would impair wound healing including :
• Subjects with renal impairment (creatinine clearance (CLcr) of 80/ml/min or less)
• Significant hepatic impairment (LFTs \>3 times upper limit of normal).
• Congestive heart failure with a classification of \>2 according to the NYHA Classification (see appendix 5).
• A history of myocardial infarction, ischaemic heart disease (or presenting with symptoms or signs compatible with ischaemic heart disease), coronary vasospasm or peripheral vascular disease.
• Subjects, with significant cerebrovascular disease including a history of stroke, transient ischaemic attacks or haemorrhage.
• Malignancy (unless treated and disease-free for 5 years).
• Autoimmune disease (including active rheumatoid arthritis), immunosuppression (oral corticosteroids) or chemotherapy within the last 12 months.
• Uncontrolled hypertension SBP \> 180 mmHg, DBP \> 95mmHg.
• Diabetes (except diet controlled)

Sponsors & Collaborators

• Renovo: lead

Study Sites (1)

09Clinical Trials Unit, Renovo Limited

Manchester, M13 9XX, United Kingdom

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

mannose-6-phosphate

Study Officials

• Jim Bush, MBChB. MRCS

  General Medical Council

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: April 22, 2008
• Study Start: February 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: November 1, 2008
• Last Updated: January 6, 2009

Record last verified: 2009-01

Locations

GB (1)