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Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea

Primary Purpose

Rosacea

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

CD07805/47 gel 0.5%

About this trial

This is an interventional treatment trial for Rosacea focused on measuring 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 or older.
A clinical diagnosis of facial rosacea.
A Clinician Erythema Assessment (CEA) score of ≥3 at Screening and at Baseline (prior to study drug application).
A Patient Self Assessment (PSA) score of ≥3 at Screening and at Baseline (prior to study drug application).

Exclusion Criteria:

Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia.
Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression.
Previous refractive eye surgery such as photorefractive keratectomy (PRK), laser-assisted sub-epithelial keratectomy (LASEK), or laser-assisted in situ keratomileusis (LASIK).
Current treatment with monoamine oxidase (MAO) inhibitors.
Current treatment with barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists.
Less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents.

Sites / Locations

The Laser Institute for Dermatology
Cherry Creek Research, Inc
Longmont Clinical PC
Gwinnett Clinical Research Center, Inc
Deaconess Clinic
Compliant Clinical Research
Hamzavi Dermatology
Dermcenter PC- Somerset Skin Centre
Minnesota Clinical Study Center
Skin Specialists, PC
DermResearch Center of New York, Inc
Metrolina Medical Research
Dermatology, Laser & Vein Specialists of the Carolinas
Wilmington Medical Research
Piedmont Medical Research
DermDox
Palmetto Medical Research
Rivergate Dermatology Clinical Research Center, PLLC
East Tennessee Medical Research
TriCities Medical Research
Tennessee Clinical Research Center
Arlington Center for Dermatology
Dermatology Clinical Research Center of San Antonio
Progressive Clinical Research, PA
Dermatology Research Center
Wenatchee Valley Medical Center - Clinical Research Department
Madison Skin & Research, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CD07805/47 Gel 0.5%

Arm Description

Outcomes

Primary Outcome Measures

Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea.

Static evaluation of erythema severity using the Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema / Almost clear; slight redness / Mild erythema; definite redness / Moderate erythema; marked redness / Severe erythema; fiery redness Change in CEA from Baseline CEA (T0 at Baseline visit Day 1) at T3 of each post-baseline visit, including Day 1.

Secondary Outcome Measures

Full Information

NCT ID

NCT01318733

First Posted

March 9, 2011

Last Updated

February 16, 2021

Sponsor

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT01318733

Brief Title

Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea

Official Title

A Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of CD07805/47 Gel 0.5% Applied Topically Once Daily for up to 52 Weeks in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

July 2012 (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

A long-term, open-label, non-comparative safety and efficacy study of CD07805/47 gel 0.5% once daily in subjects with moderate to severe facial erythema associated with rosacea.

6. Conditions and Keywords

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

Rosacea

Keywords

Rosacea

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

449 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CD07805/47 Gel 0.5%

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

CD07805/47 gel 0.5%

Intervention Description

In this open-label study, all subjects will receive treatment with CD07805/47 gel 0.5% applied once daily, for up to 12 months.

Primary Outcome Measure Information:

Title

Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea.

Description

Time Frame

Over 1 year

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 or older. A clinical diagnosis of facial rosacea. A Clinician Erythema Assessment (CEA) score of ≥3 at Screening and at Baseline (prior to study drug application). A Patient Self Assessment (PSA) score of ≥3 at Screening and at Baseline (prior to study drug application). Exclusion Criteria: Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia. Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression. Previous refractive eye surgery such as photorefractive keratectomy (PRK), laser-assisted sub-epithelial keratectomy (LASEK), or laser-assisted in situ keratomileusis (LASIK). Current treatment with monoamine oxidase (MAO) inhibitors. Current treatment with barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists. Less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents.

Overall Study Officials: