Safety and Tolerability Study of ZEP-3 Cream (0.1% and 1.0%), Administered Topically In Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

July 31, 2013

Primary Completion Date

January 31, 2014

Study Completion Date

February 28, 2014

Conditions
Healthy
Interventions
DRUG

0.1% ZEP-3 cream

"Topical application of 250mg ZEP-3 cream (0.1%) vs. placebo 4 times daily The IP is applied to in advanced demarcated sites in a dose escalating mode to 3 different treatment area sizes: small area of 2x1 cm (2 cm2), medium area of 2x5 cm (10 cm2), and large area of 4x5 cm (20 cm2).~The IP ZEP-3 cream will be applied on both ventral forearms (one application site per forearm) in a non-occlusive mode, spread and rubbed over the demarcated area.~* Right arm, single treatment area - ZEP-3 (0.1%)~* Left arm, single treatment area - Placebo cream"

DRUG

placebo

"Topical application of 250mg ZEP-3 cream (1.0%) vs. placebo 4 times daily The IP is applied to in advanced demarcated sites in a dose escalating mode to 3 different treatment area sizes: small area of 2x1 cm (2 cm2), medium area of 2x5 cm (10 cm2), and large area of 4x5 cm (20 cm2).~The IP ZEP-3 cream will be applied on both ventral forearms (one application site per forearm) in a non-occlusive mode, spread and rubbed over the demarcated area.~Right arm, single treatment area - ZEP-3 (1.0%)~Left arm, single treatment area - Placebo cream"

Trial Locations (1)

52621

Sheba Medical Center, Ramat Gan

All Listed Sponsors
lead

Shulov Innovate for Science Ltd. 2012

INDUSTRY

NCT01863160 - Safety and Tolerability Study of ZEP-3 Cream (0.1% and 1.0%), Administered Topically In Healthy Volunteers | Biotech Hunter | Biotech Hunter