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

Psoriasis Vulgaris Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

• NCT number: NCT00593177
• Study type: Interventional
• Source: Manhattan Pharmaceuticals
• Status: Completed
• Phase: Phase 2
• Start date: October 2007
• Completion date: July 2008