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Dose Response Study of Patients With Erythematous Rosacea

Primary Purpose

Erythematous (Type One) Rosacea

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

V-101

vehicle

About this trial

This is an interventional treatment trial for Erythematous (Type One) Rosacea focused on measuring Rosacea, erythema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

male or females at least 18 years of age
diagnosis of stable erythematous rosacea
< 3 inflammatory lesions
in good general health
females must be non-pregnant and non-lactating
must be willing to sign a consent form

Exclusion Criteria:

have ocular, phymatous or other types of rosacea
allergy to any ingredient in study drug
participation in other investigational studies within 30 days of enrollment
use of systemic steroids within 28 days of Baseline
use of tetracycline antibiotics within 28 days of baseline
use of products containing oxymetazoline within 14 days of baseline
use of topical steroids witin treatment area 14 days prior to baseline
use of Rx or OTC products for treatment of acne or rosacea within 14 days of baseline
use of any product for reducing redness within the treatment area witin 14 days prior to baseline
use of monoamine oxidase (MAO) inhibitors
use of niacin >/= 500mg/day

Sites / Locations

Therapeutics Clinical Research
Baumann Cosmetic & Research Institute
Dermatology Specialists Research
DBA Michigan Center for Skin Care Research
Academic Dermatology Associates
Oregon Medical Research Center, PC
DermResearch, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

V-101 Cream 0.01% Concentration

V-101 Cream 0.06% Concentration

V-101 Cream 0.1% Concentration

V-101 Cream 0.15% Concentration

Vehicle

Arm Description

Low dose

Mid-dose

High dose

Cream without an active ingredient

Outcomes

Primary Outcome Measures

Clinician's Erythema Assessment

Physician visual evaluation

Secondary Outcome Measures

Subject's Self Assessment

Patient assesses their condition

Full Information

NCT ID

NCT01186068

First Posted

August 17, 2010

Last Updated

November 22, 2010

Sponsor

Vicept Therapeutics, Inc.

Collaborators

Accenture

1. Study Identification

Unique Protocol Identification Number

NCT01186068

Brief Title

Dose Response Study of Patients With Erythematous Rosacea

Official Title

A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study of the Dose-Response Profile of V-101 Cream in Subjects With Erythematous Rosacea

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Vicept Therapeutics, Inc.

Collaborators

Accenture

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the dose-response relationship (effect) of four concentrations of V-101 Cream in patients with erythematous(redness) rosacea.

Detailed Description

Patients must have moderate to severe erythematous (facial redness) rosacea Male and female patients must be at least 18 years old and in good general health Female patients must not be pregnant or nursing

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erythematous (Type One) Rosacea

Keywords

Rosacea, erythema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

175 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

V-101 Cream 0.01% Concentration

Arm Type

Experimental

Arm Description

Low dose

Arm Title

V-101 Cream 0.06% Concentration

Arm Type

Experimental

Arm Description

Mid-dose

Arm Title

V-101 Cream 0.1% Concentration

Arm Type

Experimental

Arm Description

Mid-dose

Arm Title

V-101 Cream 0.15% Concentration

Arm Type

Experimental

Arm Description

High dose

Arm Title

Vehicle

Arm Type

Placebo Comparator

Arm Description

Cream without an active ingredient

Intervention Type

Drug

Intervention Name(s)

V-101

Intervention Description

Cream QD

Intervention Type

Other

Intervention Name(s)

vehicle

Intervention Description

Cream QD

Primary Outcome Measure Information:

Title

Clinician's Erythema Assessment

Description

Physician visual evaluation

Time Frame

Day 28 visit

Secondary Outcome Measure Information:

Title

Subject's Self Assessment

Description

Patient assesses their condition

Time Frame

28 Day Visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: male or females at least 18 years of age diagnosis of stable erythematous rosacea < 3 inflammatory lesions in good general health females must be non-pregnant and non-lactating must be willing to sign a consent form Exclusion Criteria: have ocular, phymatous or other types of rosacea allergy to any ingredient in study drug participation in other investigational studies within 30 days of enrollment use of systemic steroids within 28 days of Baseline use of tetracycline antibiotics within 28 days of baseline use of products containing oxymetazoline within 14 days of baseline use of topical steroids witin treatment area 14 days prior to baseline use of Rx or OTC products for treatment of acne or rosacea within 14 days of baseline use of any product for reducing redness within the treatment area witin 14 days prior to baseline use of monoamine oxidase (MAO) inhibitors use of niacin >/= 500mg/day

Overall Study Officials: