NCT01355458

Brief Summary

Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once daily is more efficacious than vehicle and provides an acceptable safety profile in the treatment of facial erythema associated with rosacea.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2011

Shorter than P25 for phase_3

Geographic Reach
2 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2 years until next milestone

Results Posted

Study results publicly available

November 21, 2013

Completed
Last Updated

February 18, 2021

Status Verified

September 1, 2013

Enrollment Period

4 months

First QC Date

May 16, 2011

Results QC Date

September 19, 2013

Last Update Submit

February 16, 2021

Conditions

Rosacea

Keywords

rosacea

Outcome Measures

Primary Outcomes (1)

  • Composite Success

    Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).

    Day 29

Study Arms (2)

CD07805/47 gel

EXPERIMENTAL
Drug: CD07805/47 gel

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

CD07805/47 gelDRUG

applied topically once daily

CD07805/47 gel
PlaceboDRUG

applied topically once daily

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 greater than or equal to 3 at Screening and at Baseline/Day 1 (prior to the study drug application).
  • A Patient Self Assessment (PSA) score of greater than or equal to 3 at Screening and at Baseline/Day 1 (prior to the study drug application).

You may not qualify if:

  • 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.
  • Presence of three (3) or more facial inflammatory lesions of rosacea.
  • Current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha agonists.
  • Less than 3 months stable dose treatment with tricyclic antidepressants, cardiac glycosides, beta blockers or other antihypertensive agents.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Michigan Center for Skin Care Research

Clinton Township, Michigan, 48038, United States

Location

Windsor Dermatology

East Windsor, New Jersey, 08520, United States

Location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97223, United States

Location

Philadelphia Institute of Dermatology

Fort Washington, Pennsylvania, 19034, United States

Location

The Skin Wellness Center

Knoxville, Tennessee, 37922, United States

Location

Arlington Center for Dermatology

Arlington, Texas, 76011, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

Dermatology Treatment & Research Center

Dallas, Texas, 72230, United States

Location

The Education & Research Foundation, Inc.

Lynchburg, Virginia, 24501, United States

Location

Lynderm Research Inc

Markham, Ontario, L3P 1A8, Canada

Location

Windsor Clinical Research Inc.

Windsor, Ontario, N8W 5L7, Canada

Location

Innovaderm Research, Inc

Montreal, Quebec, H2K 4L5, Canada

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Michael Graeber, MD
Organization
Galderma
michael.graeber@galderma.com
609-860-8201

Study Officials

  • Michael Graeber, MD

    Galderma R&D

    STUDY CHAIR

  • William Abramovits, MD

    Dermatology Treatment & Research Center

    PRINCIPAL INVESTIGATOR

  • Robert Bissonette, MD

    Innovaderm Research Inc.

    PRINCIPAL INVESTIGATOR

  • Zoe Draelos, MD

    Dermatology Consulting Services, High Point NC

    PRINCIPAL INVESTIGATOR

  • Kimberly Grande, MD

    The Skin Wellness Center

    PRINCIPAL INVESTIGATOR

  • Michael Jarratt, MD

    Derm Research, PLLC

    PRINCIPAL INVESTIGATOR

  • Charles Lynde, MD

    Lynderm Research Inc

    PRINCIPAL INVESTIGATOR

  • Robert Matheson, MD

    Oregon Medical Research Center

    PRINCIPAL INVESTIGATOR

  • Kappa Meadows, MD

    The Education & Research Foundation, Inc.

    PRINCIPAL INVESTIGATOR

  • Angela Moore, MD

    Arlington Center for Dermatology

    PRINCIPAL INVESTIGATOR

  • David Nieves, MD

    Windsor Dermatology

    PRINCIPAL INVESTIGATOR

  • Andrew Pollack, MD

    Philadelphia Institute of Dermatology

    PRINCIPAL INVESTIGATOR

  • Howard Sofen, MD

    Dermatology Research Associates

    PRINCIPAL INVESTIGATOR

  • Martin Steinhoff, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Daniel Stewart, DO

    Michigan Center for Skin Care Research

    PRINCIPAL INVESTIGATOR

  • Jerry Tan, MD

    Windsor Clinical Research Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2011

First Posted

May 18, 2011

Study Start

May 1, 2011

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

February 18, 2021

Results First Posted

November 21, 2013

Record last verified: 2013-09

Locations

CA(3)US(12)