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Randomized Study of PH-10 for Psoriasis

NCT01247818 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2012-09-28

No results posted yet for this study

Summary

PH-10 is an aqueous hydrogel formulation of rose bengal disodium (RB) for topical administration to the skin, and is being studied for the treatment of cutaneous skin disorders, specifically psoriasis and atopic dermatitis. This multicenter phase 2 study of subjects randomized sequentially by center to one of four treatment cohorts will assess efficacy and safety of topical PH-10 applied once daily to areas of mild to moderate plaque psoriasis.

Conditions

Interventions

DRUG

PH-10 (0.002% Rose Bengal)

PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.

DRUG

PH-10 (0.005% Rose Bengal)

PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.

DRUG

PH-10 (0.01% Rose Bengal)

PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.

DRUG

Vehicle

PH-10 vehicle will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.

Sponsors & Collaborators

  • Provectus Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Eric Wachter, Ph.D. · Provectus Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-08-31
Completion
2012-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01247818 on ClinicalTrials.gov