NCT01789775

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
114

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_3

Geographic Reach
3 countries

7 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

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 20, 2014

Completed
Last Updated

October 20, 2014

Status Verified

October 1, 2014

Enrollment Period

10 months

First QC Date

February 8, 2013

Results QC Date

October 14, 2014

Last Update Submit

October 14, 2014

Conditions

Rosacea

Outcome Measures

Primary Outcomes (1)

  • Composite Success Assessment (CEA) and Patient Self Assessment(PSA).

    Composite Success is defined as 1-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).

    Day 29

Secondary Outcomes (1)

  • Composite Success Assessment (CEA) and Patient Self Assessment(PSA).

    D1

Study Arms (2)

CD07805/47 gel Placebo

PLACEBO COMPARATOR

Placebo

Drug: Drug: CD07805/47 gel

CD07805/47 gel

EXPERIMENTAL

Intervention: Drug: CD07805/47 gel

Drug: CD07805/47 gel Placebo

Interventions

Drug: CD07805/47 gelDRUG
CD07805/47 gel Placebo
CD07805/47 gel PlaceboDRUG
CD07805/47 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 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:

  • More than 20 facial inflammatory lesions of rosacea
  • 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 treatment with monoamine oxidase (MAO) inhibitors, 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.
  • 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 (7)

Galderma Investigational Site

Montpellier, 34, France

Location

Galderma Investigational Site

Nice, 06, France

Location

Galderma Investigational Site

Chelyabinsk, Russia

Location

Galderma Investigational Site

Moscow, Russia

Location

Galderma Investigational Site

Saint Petersburg, Russia

Location

Galderma Investigational Site

Yekaterinburg, Russia

Location

Galderma Investigational Site

Eskilstuna, Sweden

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Galderma CPM
Organization
Galderma R&D
clinicaltrials@galderma.com
00 33 4 93 95 70 70

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

February 8, 2013

First Posted

February 12, 2013

Study Start

December 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

October 20, 2014

Results First Posted

October 20, 2014

Record last verified: 2014-10

Locations

FR(2)RU(4)SE(1)