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Dose-Finding Study of CD07805/47 Topical Gel in Subjects With Erythematotelangiectatic Rosacea

Primary Purpose

Erythematotelangiectatic Rosacea

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

CD07805/47

CD07805/47 placebo

About this trial

This is an interventional treatment trial for Erythematotelangiectatic Rosacea focused on measuring Erythematotelangiectatic, Rosacea

Eligibility Criteria

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

Inclusion Criteria:

Male or female who is at least 18 years of age.
Clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea.
CEA (clinician's erythema assessment) score greater than or equal to 3 at Screening and on Treatment visit at baseline.
PSA (patient self assessment) score of greater than or equal to 3 at Screening and on Treatment visit at baseline.
Presence of 2 or fewer inflammatory facial lesions.

Exclusion Criteria:

History of Raynaud's Syndrome, glaucoma, orthostatic hypotension, thromboangiitis obliterans, cerebral or coronary insufficiency, or depression.
History of refractive surgery such as photorefractive keratectomy.
The subject is being treated with monoamine oxidase (MAO) inhibitor, anti-depressants, barbiturates, opiates, sedatives, systemic anesthetics, alpha-agonists, beta blockers, antihypertensive agents, cardiac glycosides, or systemic anticoagulants.
The subject is currently enrolled in an investigational drug or device study or participated in such a study in the past 3 months prior to enrollment and is still in the exclusion period on the day of the Treatment visit.

Sites / Locations

Burke Pharmaceutical Research
Philadephia Institute of Dermatology
Derm Research, Inc
J&S Studies
The Education & Research Foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

CD07805/47 0.5% Topical Gel

CD07805/47 0.18% Topical Gel

CD07805/47 0.07% Topical Gel

CD07805/47 Vehicle Topical Gel

Arm Description

0.5% Topical Gel

0.18% Topical Gel

0.07% Topical Gel

Vehicle Topical Gel

Outcomes

Primary Outcome Measures

Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing.

Secondary Outcome Measures

Full Information

NCT ID

NCT00989014

First Posted

September 30, 2009

Last Updated

February 16, 2021

Sponsor

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT00989014

Brief Title

Dose-Finding Study of CD07805/47 Topical Gel in Subjects With Erythematotelangiectatic Rosacea

Official Title

Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Dose-Finding Study Investigating the Pharmacodynamics and Safety of Three Concentrations of CD07805/47 Topical Gel (0.07%, 0.18%, and 0.50%), Applied in Subjects With Moderate to Severe Erythematotelangiectatic Rosacea

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galderma R&D

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel (0.07%, 0.18%, and 0.50%), after a single application in subjects with a clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea. Subjects will be randomized in a 1:1:1:1 ratio to receive either one of three CD07805/47 topical gel concentrations (0.07%, 0.18%, or 0.50%) or Vehicle Gel. All subjects will be treated with a single application (once daily dosing for one day) of study medication.

6. Conditions and Keywords

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

Erythematotelangiectatic Rosacea

Keywords

Erythematotelangiectatic, Rosacea

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CD07805/47 0.5% Topical Gel

Arm Type

Experimental

Arm Description

0.5% Topical Gel

Arm Title

CD07805/47 0.18% Topical Gel

Arm Type

Experimental

Arm Description

0.18% Topical Gel

Arm Title

CD07805/47 0.07% Topical Gel

Arm Type

Experimental

Arm Description

0.07% Topical Gel

Arm Title

CD07805/47 Vehicle Topical Gel

Arm Type

Placebo Comparator

Arm Description

Vehicle Topical Gel

Intervention Type

Drug

Intervention Name(s)

CD07805/47

Intervention Description

0.5% Topical Gel

Intervention Type

Drug

Intervention Name(s)

CD07805/47

Intervention Description

0.18% Topical Gel

Intervention Type

Drug

Intervention Name(s)

CD07805/47

Intervention Description

0.07% Topical Gel

Intervention Type

Drug

Intervention Name(s)

CD07805/47 placebo

Intervention Description

Vehicle Topical Gel

Primary Outcome Measure Information:

Title

Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing.

Time Frame

Baseline and every hour for 12 hours following application

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female who is at least 18 years of age. Clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea. CEA (clinician's erythema assessment) score greater than or equal to 3 at Screening and on Treatment visit at baseline. PSA (patient self assessment) score of greater than or equal to 3 at Screening and on Treatment visit at baseline. Presence of 2 or fewer inflammatory facial lesions. Exclusion Criteria: History of Raynaud's Syndrome, glaucoma, orthostatic hypotension, thromboangiitis obliterans, cerebral or coronary insufficiency, or depression. History of refractive surgery such as photorefractive keratectomy. The subject is being treated with monoamine oxidase (MAO) inhibitor, anti-depressants, barbiturates, opiates, sedatives, systemic anesthetics, alpha-agonists, beta blockers, antihypertensive agents, cardiac glycosides, or systemic anticoagulants. The subject is currently enrolled in an investigational drug or device study or participated in such a study in the past 3 months prior to enrollment and is still in the exclusion period on the day of the Treatment visit.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Graeber, MD

Organizational Affiliation

Galderma R&D

Official's Role

Study Director

Facility Information:

Facility Name

Burke Pharmaceutical Research

City

Hot Springs

State/Province

Arkansas

ZIP/Postal Code

71913

Country

United States

Facility Name

Philadephia Institute of Dermatology

City

Fort Washington

State/Province

Pennsylvania

ZIP/Postal Code

19034

Country

United States

Facility Name

Derm Research, Inc

City

Austin

State/Province

Texas

ZIP/Postal Code

78759

Country

United States

Facility Name

J&S Studies

City

College Station

State/Province

Texas

ZIP/Postal Code

77845

Country

United States

Facility Name

The Education & Research Foundation

City

Lynchburg

State/Province

Virginia

ZIP/Postal Code

24501

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Dose-Finding Study of CD07805/47 Topical Gel in Subjects With Erythematotelangiectatic Rosacea

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