Investigation of the Efficacy of Zesteem in Accelerating Early Wound Healing
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|ClinicalTrials.gov Identifier: NCT00984386|
Recruitment Status : Completed
First Posted : September 25, 2009
Last Update Posted : September 25, 2009
|Condition or disease||Intervention/treatment||Phase|
|Cicatrix Wound-healing||Drug: Zesteem Drug: Placebo||Phase 2|
Each subject received a total of six, 3mm punch biopsy wounds; three wounds to the upper inner aspect of each arm. Each punch biopsy site was randomly allocated to receive one of six treatments: Zesteem (0.02μg, 0.1μg, 0.2μg and 0.4μg/100μl), Placebo (vehicle), and Standard Care (moist wound healing dressings) only.
Zesteem and Placebo were administered to marked, anaesthetised sites, by intradermal injection 10 to 30 minutes before wounding. Sites randomised to receive Standard Care only received no additional treatment before wounding. After wounding, all sites received moist wound healing dressings (Standard Care).
Three days after wounding, all biopsy sites were anaesthetised and the wounds excised using a 5mm punch biopsy, for histological analysis. The Investigator closed all excision sites using sutures and Steri-strips to achieve a cosmetically acceptable result. Subjects attended a post-trial follow-up visit (13-18 days after dosing) where their sutures were removed and final safety assessments were performed.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Single Site, Placebo and Standard Care Controlled, Double Blind, Randomised Trial to Investigate the Efficacy of Four Doses of Zesteem in Accelerating Early Wound Healing of Punch Biopsy Skin Wounds.|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||April 2005|
|Actual Study Completion Date :||April 2005|
|Experimental: Intradermal Zesteem||
Intradermal Zesteem, 0.02μg/100μl administered once before punch biopsy
Intradermal Zesteem, 0.1μg/100μl administered once before punch biopsy
Intradermal Zesteem, 0.2μg/100μl administered once before punch biopsy
Intradermal Zesteem, 0.4μg/100μl administered once before punch biopsy
|Placebo Comparator: Placebo||
Intradermal placebo, 100μl administered once before punch biopsy
- To assess acceleration of early wound healing in male and postmenopausal female subjects following administration of intradermal Zesteem. The primary trial endpoint will be the distance travelled by the epithelium over the biopsy site. [ Time Frame: Day 3 ]
- To assess safety and tolerability of intradermal Zesteem in male and post-menopausal female subjects. [ Time Frame: 13-18 Days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00984386
|Renovo Clinical Trials Unit|
|Manchester, United Kingdom, M13 9XX|
|Principal Investigator:||Jonathan Duncan||Renovo|