NCT00593177

A Safety and Efficacy Study of a Topical Gel for the Treatment of Mild to Moderate Psoriasis

A Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of 0.10% or 0.05% PTH (1-34) Gel Versus Placebo Gel in the Treatment of Mild to Moderate Plaque Psoriasis.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Manhattan Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to assess the tolerability and efficacy of a 0.10% or 0.05% PTH (1-34) parathyroid hormone peptide gel in the treatment of mild to moderate plaque psoriasis in comparison to treatment with the placebo gel alone.

Detailed description

This pilot study aims to confirm the results of a previous proof of concept study performed by Dr. Michael Holick using a different dosage form. The secondary objective is to determine if there is a dose dependent difference or trend in response between the two concentrations of PTH (1-34) peptide gel. Subjects will be randomized to receive one of three treatment groups on a 1:1:1 basis. The three treatment groups are: * Treatment Group 1: 0.05% PTH (1-34) Gel * Treatment Group 2: 0.10% PTH (1-34) Gel * Treatment Group 3: Placebo Gel

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
DRUG	PTH (1-34) Gel / Placebo Gel	Topical dosing of gel twice daily for eight weeks.

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-06-01
• Completion: 2008-07-01
• First posted: 2008-01-14
• Last updated: 2008-08-19

Locations

4 sites across 1 country: United States