RosaceaPhase 3NCT01318733

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

A Phase 3 study testing CD07805/47 gel 0.5% in people with Rosacea, run by Galderma R&D at 27 sites in United States.

Completed

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

Trial summary

A long-term, open-label, non-comparative safety and efficacy study of CD07805/47 gel 0.5% once daily in subjects with moderate to severe facial erythema associated with rosacea. 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 0.5%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 449 participants
Where: 27 sitesUnited States
Study dates: Mar 2011to Jul 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 ≥3 at Screening and at Baseline (prior to study drug application).
A Patient Self Assessment (PSA) score of ≥3 at Screening and at Baseline (prior to 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.
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.
Previous refractive eye surgery such as photorefractive keratectomy (PRK), laser-assisted sub-epithelial keratectomy (LASEK), or laser-assisted in situ keratomileusis (LASIK).
Current treatment with monoamine oxidase (MAO) inhibitors.
Current treatment with 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.

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

United States27 sites

Arlington Center for Dermatology
Arlington, Texas, 76011
Metrolina Medical Research
Charlotte, North Carolina, 27277
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207
Cherry Creek Research, Inc
Denver, Colorado, 80209
Deaconess Clinic
Evansville, Indiana, 47713
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Rivergate Dermatology Clinical Research Center, PLLC
Goodlettsville, Tennessee, 37072
DermDox
Hazleton, Pennsylvania, 18201
East Tennessee Medical Research
Johnson City, Tennessee, 37604
TriCities Medical Research
Kingsport, Tennessee, 37660
Longmont Clinical PC
Longmont, Colorado, 80501
Madison Skin & Research, Inc.
Madison, Wisconsin, 53719
Palmetto Medical Research
Mt. Pleasant, South Carolina, 29464
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Compliant Clinical Research
Olathe, Kansas, 66061
Skin Specialists, PC
Omaha, Nebraska, 68144
Dermatology Research Center
Salt Lake City, Utah, 84124
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
Progressive Clinical Research, PA
San Antonio, Texas, 78229
The Laser Institute for Dermatology
Santa Monica, California, 90404
Gwinnett Clinical Research Center, Inc
Snellville, Georgia, 30078
DermResearch Center of New York, Inc
Stony Brook, New York, 11790
Dermcenter PC- Somerset Skin Centre
Troy, Michigan, 48084
Wenatchee Valley Medical Center - Clinical Research Department
Wenatchee, Washington, 98801
Wilmington Medical Research
Wilmington, North Carolina, 28401
Piedmont Medical Research
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of CD07805/47 Gel 0.5% Applied Topically Once Daily for up to 52 Weeks in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea

A long-term, open-label, non-comparative safety and efficacy study of CD07805/47 gel 0.5% once daily in subjects with moderate to severe facial erythema associated with rosacea.

Conditions: Rosacea
Being tested: CD07805/47 gel 0.5%
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 gel 0.5%Drug
In this open-label study, all subjects will receive treatment with CD07805/47 gel 0.5% applied once daily, for up to 12 months.

Study groups in NCT01318733
Study group	Role	What they receive
CD07805/47 Gel 0.5%	Experimental	Not described Receives: Drug: CD07805/47 gel 0.5%

What is being measured

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

Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea.
Static evaluation of erythema severity using the Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema
1. / Almost clear; slight redness
2. / Mild erythema; definite redness
3. / Moderate erythema; marked redness
4. / Severe erythema; fiery redness
Change in CEA from Baseline CEA (T0 at Baseline visit Day 1) at T3 of each post-baseline visit, including Day 1.
Measured: Over 1 year

Timeline

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

Mar 2011Jul 2012

First posted18 Mar 2011 (estimated)
Study startMar 2011
Primary completionJun 2012
Study completionJul 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 449 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01318733
Sponsor's protocol ID: RD.06.SPR.18142
Status last verified: Mar 2014
First submitted: 9 Mar 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, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of CD07805/47 Gel 0.5% Applied Topically Once Daily for up to 52 Weeks in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea
ClinicalTrials.gov ID: NCT01318733
Acronym / sponsor ID: RD.06.SPR.18142
Conditions: Rosacea
Keywords: Rosacea
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 449 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Jun 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 18 Mar 2011 (estimated)
Results: Posted 8 Jan 2014

Clinical summary

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

A long-term, open-label, non-comparative safety and efficacy study of CD07805/47 gel 0.5% once daily in subjects with moderate to severe facial erythema associated with rosacea.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CD07805/47 Gel 0.5%	Experimental	Drug: CD07805/47 gel 0.5%

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 ≥3 at Screening and at Baseline (prior to study drug application).
A Patient Self Assessment (PSA) score of ≥3 at Screening and at Baseline (prior to study drug application).

Key exclusion criteria (6 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.
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.
Previous refractive eye surgery such as photorefractive keratectomy (PRK), laser-assisted sub-epithelial keratectomy (LASEK), or laser-assisted in situ keratomileusis (LASIK).
Current treatment with monoamine oxidase (MAO) inhibitors.
Current treatment with barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists.

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 gel 0.5%In this open-label study, all subjects will receive treatment with CD07805/47 gel 0.5% applied once daily, for up to 12 months.	Drug	CD07805/47 Gel 0.5%

Primary outcome

Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea.
Time frame: Over 1 year
Static evaluation of erythema severity using the Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema 1. / Almost clear; slight redness 2. / Mild erythema; definite redness 3. / Moderate erythema; marked redness 4. / Severe erythema; fiery redness Change in CEA from Baseline CEA (T0 at Baseline visit Day 1) at T3 of each post-baseline visit, including Day 1.

Results and safety

Results posted to the registry on 8 Jan 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%	449	279

Primary outcome: Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea.

Time frame: Over 1 year. Mean (Standard Deviation). Unit: scores on a scale

Measure	CD07805/47 Gel 0.5% QD n = 449
Day 1 / Hour 3	-1.5 (.88)
Week 1/ Hour 3	-1.4 (.85)
Month 1/ Hour 3	-1.5 (.83)
Month 3 / Hour 3	-1.7 (.84)
Month 6 / Hour 3	-1.8 (.88)
Month 9 / Hour 3	-1.7 (.9)
Month 12 / Hour 3	-1.8 (.83)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CD07805/47 Gel 0.5%	12 of 449 (2.7%)	101 of 449 (22.5%)	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.

Scott Clark, MD principal investigator

Longmont Clinical PC

Lesly Davidson, MD principal investigator

Palmetto Medical Research

Steven Davis, MD principal investigator

Dermatology Clinical Research Center of San Antonio

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CD07805/47 gel 0.5% in people with Rosacea, run by Galderma R&D at 27 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 4 inclusion and 6 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 27 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. 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 8 Jan 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?

Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea. (time frame: Over 1 year). 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 NCT01318733.

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.