RosaceaPhase 2NCT01174030

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

A Phase 2 study testing CD07805/47 Gel in people with Rosacea, run by Galderma R&D at 20 sites in United States.

Completed

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

Trial summary

The purpose of this vehicle controlled study is to evaluate the efficacy and safety of CD07805/47 gel 0.5% applied topically once daily (QD) for 4 weeks, and CD07805/47 gel 0.18% applied topically once daily (QD) or twice daily (BID) for 4 weeks, in subjects with moderate to severe facial erythema associated with… 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: 269 participants
Where: 20 sitesUnited States
Study dates: Aug 2010to Jan 2011
Phase: Phase 2
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 rosacea.
A Clinician Erythema Assessment (CEA) score of 3 at Screening and at Pre-dose (T0) on Baseline/Day 1.
A Patient Self Assessment-5 (PSA-5) score of 3 at Screening and at Pre-dose (T0) on Baseline/Day 1.
A Patient Self Assessment-11 (PSA-11) score of 5 at Screening and at Pre-dose (T0) on Baseline/Day 1.

Who cannot join

Three (3) or more facial inflammatory lesions.
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.
Known allergies or sensitivities to any components of the study medications, including the active gel ingredient, brimonidine tartrate.
Intraocular pressure (IOP) measurement less than 10 mm Hg.

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Arlington Center for Dermatology
Arlington, Texas, 76011
Dermatology Laser & Vein Specialists
Charlotte, North Carolina, 28207
Dermatology Treatment & Research Center
Dallas, Texas, 75230
Philadelphia Institute of Dermatology
Fort Washington, Pennsylvania, 19034
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina, 29007
DermDox
Hazleton, Pennsylvania, 18201
Dermatology Consulting Services
High Point, North Carolina, 27262
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
The Skin Wellness Center
Knoxville, Tennessee, 37902
Dermatology Specialists PC
Louisville, Kentucky, 40202
The Education & Research Foundation
Lynchburg, Virginia, 24501
Madison Skin & Research
Madison, Wisconsin, 53719
Skin Specialty Group
New York, New York, 10021
Meda Phase, Inc
Newnan, Georgia, 30263
Oregon Dermatology & Research Center
Portland, Oregon, 97210
Oregon Medical Research
Portland, Oregon, 97223
University of California at San Francisco
San Francisco, California, 94143-0660
Premier Clinical Research
Spokane, Washington, 99204
Central Dermatology, PC
St Louis, Missouri, 63117

Other trials in United States

About this study

Official title: A 4-week, Randomized, Double-blind, Parallel-group, Vehicle-controlled, Multicenter Study Investigating the Efficacy and Safety of CD07805/47 Gel 0.5% Applied Topically Once Daily (QD), and CD07805/47 Gel 0.18% Applied Topically Once Daily (QD) or Twice Daily (BID), in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea

Conditions: Rosacea
Being tested: CD07805/47 Gel, Vehicle Gel
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
CD07805/47 Gel 0.5% QD
Vehicle GelDrug
Vehicle Gel QD
CD07805/47 GelDrug
CD07805/47 Gel 0.18% QD
CD07805/47 GelDrug
CD07805/47 Gel 0.18% BID
Vehicle GelDrug
Vehicle Gel BID

Study groups in NCT01174030
Study group	Role	What they receive
CD07805/47 Gel 0.5% QD	Experimental	Not described Receives: Drug: CD07805/47 Gel
CD07805/47 Gel 0.18% QD	Experimental	Not described Receives: Drug: CD07805/47 Gel
CD07805/47 Gel 0.18% BID	Experimental	Not described Receives: Drug: CD07805/47 Gel
Vehicle Gel QD	Placebo comparator	Not described Receives: Drug: Vehicle Gel
Vehicle Gel BID	Placebo comparator	Not described Receives: Drug: Vehicle Gel

What is being measured

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

Composite Success
Composite success defined as 2-grade improvement on Clinician Erythema Assessment (CEA)and Patient Self Assessment-5 (PSA-5).
Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.
Measured: Day 29

Secondary outcomes (2)

CEA Success
CEA success defined as 2-grade improvement on CEA.
Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.
Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema
1. / Amost clear; slight redness
2. / Mild erythema; definite redness
3. / Moderate erythema; marked redness
4. / Severe erythema; fiery redness
Measured: Day 29
PSA-5 Success
Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.
PSA-5 success defined as 2-grade improvement on PSA-5.
Patient Self Assessment - 5 (PSA-5) - Grade/description 0 / No redness
1. / Very mild redness
2. / Mild redness
3. / Moderate redness
4. / Severe redness
Measured: day 29

Timeline

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

Aug 2010Jan 2011

First posted3 Aug 2010 (estimated)
Study startAug 2010
Primary completionDec 2010
Study completionJan 2011

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 269 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01174030
Sponsor's protocol ID: RD.06.SPR.18161
Status last verified: Jan 2014
First submitted: 30 Jul 2010
Last updated: 26 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 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 4-week, Randomized, Double-blind, Parallel-group, Vehicle-controlled, Multicenter Study Investigating the Efficacy and Safety of CD07805/47 Gel 0.5% Applied Topically Once Daily (QD), and CD07805/47 Gel 0.18% Applied Topically Once Daily (QD) or Twice Daily (BID), in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea
ClinicalTrials.gov ID: NCT01174030
Acronym / sponsor ID: RD.06.SPR.18161
Conditions: Rosacea
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 269 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Dec 2010 (actual)
Study completion: Jan 2011 (actual)
First posted: 3 Aug 2010 (estimated)
Results: Posted 11 Mar 2014

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: 5

Arm	Type	Receives
CD07805/47 Gel 0.5% QD	Experimental	Drug: CD07805/47 Gel
CD07805/47 Gel 0.18% QD	Experimental	Drug: CD07805/47 Gel
CD07805/47 Gel 0.18% BID	Experimental	Drug: CD07805/47 Gel
Vehicle Gel QD	Placebo comparator	Drug: Vehicle Gel
Vehicle Gel BID	Placebo comparator	Drug: Vehicle Gel

Who may qualify

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

Key inclusion criteria (5 listed)

Male or female, who is at least 18 years of age or older.
A clinical diagnosis of rosacea.
A Clinician Erythema Assessment (CEA) score of 3 at Screening and at Pre-dose (T0) on Baseline/Day 1.
A Patient Self Assessment-5 (PSA-5) score of 3 at Screening and at Pre-dose (T0) on Baseline/Day 1.
A Patient Self Assessment-11 (PSA-11) score of 5 at Screening and at Pre-dose (T0) on Baseline/Day 1.

Key exclusion criteria (4 listed)

Three (3) or more facial inflammatory lesions.
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.
Known allergies or sensitivities to any components of the study medications, including the active gel ingredient, brimonidine tartrate.
Intraocular pressure (IOP) measurement less than 10 mm Hg.

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 GelCD07805/47 Gel 0.5% QD	Drug	CD07805/47 Gel 0.5% QD
Vehicle GelVehicle Gel QD	Drug	Vehicle Gel QD
CD07805/47 GelCD07805/47 Gel 0.18% QD	Drug	CD07805/47 Gel 0.18% QD
CD07805/47 GelCD07805/47 Gel 0.18% BID	Drug	CD07805/47 Gel 0.18% BID
Vehicle GelVehicle Gel BID	Drug	Vehicle Gel BID

Primary outcome

Composite Success
Time frame: Day 29
Composite success defined as 2-grade improvement on Clinician Erythema Assessment (CEA)and Patient Self Assessment-5 (PSA-5). Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.

2 secondary outcomes

CEA Success
Time frame: Day 29
PSA-5 Success
Time frame: day 29

Results and safety

Results posted to the registry on 11 Mar 2014, 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 0.5% QD	53	51
CD07805/47 Gel 0.18% QD	54	52
CD07805/47 Gel 0.18% BID	54	52
Vehicle Gel QD	55	53
Vehicle Gel BID	53	52

Primary outcome: Composite Success

Time frame: Day 29. Number. Unit: participants

Measure	CD07805/47 Gel 0.5% QD n = 53	CD07805/47 Gel 0.18% QD n = 54	CD07805/47 Gel 0.18% BID n = 54	Vehicle Gel QD n = 55	Vehicle Gel BID n = 53
Day 29/Hour 3	16	10	10	2	4
Day 29/Hour 6	15	10	9	4	7
Day 29/Hour 9	17	7	11	2	10
Day 29/Hour 12	10	5	8	2	9

CD07805/47 Gel 0.5% QD vs Vehicle Gel QD: Odds Ratio (OR): 8.392 (95% CI 2.637 to 26.710), p <0.001, GEE:Logit link function
CD07805/47 Gel 0.18% BID vs Vehicle Gel BID: Odds Ratio (OR): 1.269 (95% CI 0.586 to 2.747), p = 0.549, GEE:Logit link function
CD07805/47 Gel 0.18% QD vs Vehicle Gel QD: Odds Ratio (OR): 3.738 (95% CI 1.097 to 12.742), p = 0.027, GEE:Logit link function

Population analysed: Intent-to Treat (ITT) population, LOCF when the data are missing at all four timepoints (i.e. Hours 3, 6, 9, 12) LOCF method will be applied from previous visit.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CD07805/47 Gel 0.5% QD	0 of 53 (0%)	18 of 53 (34%)	Not reported
CD07805/47 Gel 0.18% QD	1 of 54 (1.9%)	13 of 54 (24.1%)	Not reported
CD07805/47 Gel 0.18% BID	0 of 54 (0%)	14 of 54 (25.9%)	Not reported
Vehicle Gel QD	1 of 55 (1.8%)	16 of 55 (29.1%)	Not reported
Vehicle Gel BID	0 of 53 (0%)	8 of 53 (15.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 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 director

Galderma R&D, Inc

William Abramovits, MD principal investigator

Dermatology Treatment & Research Center

Fran Cook-Bolden, MD principal investigator

Skin Specialty Group

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CD07805/47 Gel in people with Rosacea, run by Galderma R&D at 20 sites in United States.

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 5 inclusion and 4 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 26 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 20 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 11 Mar 2014). 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 NCT01174030.

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 26 Feb 2021.