Study to Determine if Fibrin Affects the Ability of a Wound to Heal

Phase 1 Completed 40 enrolled Healthpoint

RandomizedParallel-groupSingle-blindTreatment

Summary

The objective of this study is to evaluate the potential inhibitory effects of HP802-247 Vehicle on wound closure (healing), by comparing mean days to closure of superficial (partial-thickness) thermal wounds against similar wounds treated with white petrolatum.

Timeline

Start: 2011-01
Primary completion: 2011-07
Completion: 2011-11

Outcome

Missed primary endpoint

registry Control vs Test Article; p = .3393; Mean Difference (Final Values) -1.1 (95% CI -3.08 to 0.84); Prentice-Wilcoxon test NCT01253135 ↗

registry Test Article vs Control; p = .4771; Log Rank NCT01253135 ↗

Publications

Vivas A, Fox JD, Baquerizo Nole KL, Maderal AD, Badiavas E, Cargill DI, Slade HB, Feldman SR, Kirsner RS. Cryo-Induced Thermal Wounds: A Human Acute Wound Model. J Drugs Dermatol. 2015 Jul;14(7):734-8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fibrin	Protein / enzyme biologic	—	Topical

Indications

No indication recorded.