RosaceaPhase 3NCT01355471

Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea

A Phase 3 study testing CD07805/47 Gel in people with Rosacea, run by Galderma R&D at 15 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rosacea
What is being tested?: CD07805/47 Gel
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 293 participants
Where: 15 sitesin 2 countries
Study dates: May 2011to Jan 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

15 sites in 2 countries.

Country

City, postcode or hospital

15 sites in 2 countries

United States12 sites

J&S Studies Inc.
College Station, Texas, 77845
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina, 29607
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Dermatology Specialists Research
Louisville, Kentucky, 40202
Baumann Cosmetic and Research Institute
Miami Beach, Florida, 33140
Skin Specialty Dermatology
New York, New York, 10155
MedaPhase, Inc.
Newnan, Georgia, 30263
Oregon Dermatology and Research Center
Portland, Oregon, 97210
Haber Dermatology & Cosmetic Surgery
South Euclid, Ohio, 44118
Premier Clinical Research
Spokane, Washington, 99201
Central Dermatology PC
St Louis, Missouri, 63117
Grekin Skin Institute
Warren, Michigan, 48088

Other trials in United States

Canada3 sites

Kirk Barber Research Inc.
Calgary, Alberta, T25 3B3
Nexus Clinical Research
St. John's, Newfoundland and Labrador, A1A 5E8
Newlab Clinical Research Inc.
St. John's, Newfoundland and Labrador, A1C2H5

Other trials in Canada

About this study

Official title: A Multicenter, Randomized Double-Blind, Vehicle-Controlled, Parallel Group Study to Demonstrate the Efficacy and Safety of CD07805/47 Gel Applied Topically Once Daily in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea

Conditions: Rosacea
Being tested: CD07805/47 Gel, Placebo
Keywords: rosacea
Medical subject headings: Rosacea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CD07805/47 GelDrug
applied topically once daily
PlaceboDrug
applied topically once daily

Study groups in NCT01355471
Study group	Role	What they receive
CD07805/47 gel	Experimental	Not described Receives: Drug: CD07805/47 Gel
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Composite Success
Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).
Measured: Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Jan 2012

First posted18 May 2011 (estimated)
Study startMay 2011
Primary completionNov 2011
Study completionJan 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for RosaceaStudies of the same condition, open and under way.
More trials run by Galderma R&DThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 293 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01355471
Sponsor's protocol ID: RD.06.SPR.18141
Status last verified: Sep 2013
First submitted: 16 May 2011
Last updated: 18 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Enrolling by invitation
Vbeam Pro Pulse Dye Laser for the Treatment of Vascular Conditions
Rosacea, Vascular Diseases
RecruitingPhase 2
A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
Papulopustular Rosacea
Recruiting
Dermocosmetic Treatment for Facial Redness in Rosacea With or Without Laser Therapy
Rosacea, Erythematotelangiectatic, Rosacea Subtype 1 (Erythematotelangiectatic)
RecruitingObservational study
Determinants of Chronic Inflammatory Skin Disease Trajectories
Atopic Dermatitis, Psoriasis

All Rosacea trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized Double-Blind, Vehicle-Controlled, Parallel Group Study to Demonstrate the Efficacy and Safety of CD07805/47 Gel Applied Topically Once Daily in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea
ClinicalTrials.gov ID: NCT01355471
Acronym / sponsor ID: RD.06.SPR.18141
Conditions: Rosacea
Keywords: rosacea
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 293 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: May 2011
Primary completion: Nov 2011 (actual)
Study completion: Jan 2012 (actual)
First posted: 18 May 2011 (estimated)
Results: Posted 21 Nov 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
CD07805/47 gel	Experimental	Drug: CD07805/47 Gel
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CD07805/47 Gelapplied topically once daily	Drug	CD07805/47 gel
Placeboapplied topically once daily	Drug	Placebo

Primary outcome

Composite Success
Time frame: Day 29
Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).

Results and safety

Results posted to the registry on 21 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CD07805/47 Gel	148	141
Placebo	145	142

Primary outcome: Composite Success

Time frame: Day 29. Number. Unit: participants

Measure	CD07805/47 Gel n = 142	Placebo n = 142
Day 29/ Hour 3	36	13
Day 29 / Hour 6	36	13
Day 29 / Hour 9	25	15
Day 29 / Hour 12	30	14

CD07805/47 Gel vs Placebo: p <0.001, GEE: Logit link function

Population analysed: Intent-to-Treat (ITT) population(i.e. Hours 3,6,9,12)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CD07805/47 Gel	1 of 148 (0.7%)	0 of 148 (0%)	Not reported
Placebo	0 of 145 (0%)	0 of 145 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rosacea

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Enrolling by invitation
Vbeam Pro Pulse Dye Laser for the Treatment of Vascular Conditions
Rosacea, Vascular Diseases
RecruitingPhase 2
A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
Papulopustular Rosacea
Recruiting
Dermocosmetic Treatment for Facial Redness in Rosacea With or Without Laser Therapy
Rosacea, Erythematotelangiectatic, Rosacea Subtype 1 (Erythematotelangiectatic)
RecruitingObservational study
Determinants of Chronic Inflammatory Skin Disease Trajectories
Atopic Dermatitis, Psoriasis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Graeber, MD study chair

Galderma R&D

Kirk Barber, MD principal investigator

Kirk Barber Research Inc.

Leslie Baumann, MD principal investigator

Baumann Cosmetic and Research Institute

15 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CD07805/47 Gel in people with Rosacea, run by Galderma R&D at 15 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Success (time frame: Day 29). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01355471.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.