NCT00989014

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

5 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

September 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
4 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

2 months

First QC Date

September 30, 2009

Results QC Date

September 19, 2013

Last Update Submit

February 16, 2021

Conditions

Erythematotelangiectatic Rosacea

Keywords

ErythematotelangiectaticRosacea

Outcome Measures

Primary Outcomes (1)

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

    Baseline and every hour for 12 hours following application

Study Arms (4)

CD07805/47 0.5% Topical Gel

EXPERIMENTAL

0.5% Topical Gel

Drug: CD07805/47

CD07805/47 0.18% Topical Gel

EXPERIMENTAL

0.18% Topical Gel

Drug: CD07805/47

CD07805/47 0.07% Topical Gel

EXPERIMENTAL

0.07% Topical Gel

Drug: CD07805/47

CD07805/47 Vehicle Topical Gel

PLACEBO COMPARATOR

Vehicle Topical Gel

Drug: CD07805/47 placebo

Interventions

CD07805/47DRUG

0.5% Topical Gel

CD07805/47 0.5% Topical Gel
CD07805/47 placeboDRUG

Vehicle Topical Gel

CD07805/47 Vehicle Topical Gel

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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

Philadephia Institute of Dermatology

Fort Washington, Pennsylvania, 19034, United States

Location

Derm Research, Inc

Austin, Texas, 78759, United States

Location

J&S Studies

College Station, Texas, 77845, United States

Location

The Education & Research Foundation

Lynchburg, Virginia, 24501, United States

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 DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2009

First Posted

October 2, 2009

Study Start

September 1, 2009

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

February 18, 2021

Results First Posted

November 21, 2013

Record last verified: 2013-09

Locations

US(5)