ErythemaPhase 3NCT01659853

Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea

A Phase 3 study testing azelaic acid gel 15% in people with Erythema and Rosacea, run by Galderma R&D at 4 sites in United States.

Completed

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

Official record

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Trial summary

The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel 0.5% applied topically once daily versus azelaic acid gel 15% applied topically twice daily in subjects with moderate to severe facial erythema of rosacea. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Erythema, Rosacea
What is being tested?: azelaic acid gel 15%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 4 sitesUnited States
Study dates: Sep 2012to Dec 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

Subject is male or female aged 18 years or older.
Subject has a clinical diagnosis of facial rosacea.
Subject has a clinician's assessment score of moderate to severe erythema prior to enrollment.
Subject has a self assessment score of moderate to severe redness prior to enrollment.
Subjects with none to mild facial inflammatory lesions of rosacea prior to enrollment.

Who cannot join

Female subjects who are pregnant, nursing or planning a pregnancy during the study.
Subjects with a condition or who are in a situation, which in the Investigator's opinion may put a subject at risk, may confound study results, or may interfere with a subject's participation in the study.
Subjects with conditions causing facial erythema which would confound the assessment of treatment.
Subjects who are taking or have recently taken medications known to have interactions with α2-adrenergic agonists.
Subjects with known allergies or sensitivities to one of the components of the investigational products.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

DermResearch, Inc
Austin, Texas, 78759
Hudson Dermatology
Evansville, Indiana, 47714
Dermatology Specialists Research, LLC
Louisville, Kentucky, 40202
The Education & Research Foundation, Inc.
Lynchburg, Virginia, 24501

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Controlled, Double-masked, Crossover Design Study to Compare Efficacy and Assess Safety of CD07805/47 Gel 0.5% Applied Once Daily vs Azelaic Acid Gel 15% Applied Twice Daily in Subjects With Erythema of Rosacea

Read the detailed description

Adult subjects with moderate to severe facial erythema of rosacea who meet inclusion/exclusion criteria will be randomized at Baseline/Visit 1 in a 1:1 ratio to receive either CD07805/47 gel 0.5% once daily or azelaic acid gel 15% twice daily for 15 days. Following an appropriate washout period, subjects will then switch treatments and use the second investigational product as instructed for 15 days (according to the subject's randomization scheme). Subjects will re-qualify based upon inclusion/exclusion prior to Period 2 treatment.

Conditions: Erythema, Rosacea
Being tested: CD07805/47 gel 0.5%/CD07805/47 Vehicle, azelaic acid gel 15%
Medical subject headings: Erythema, 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%/CD07805/47 VehicleDrug
Also called brimonidine tartrate gel 0.5%, brimonidine tartrate gel vehicle
To maintain masking, CD07805/47 gel 0.5% will be administered along with CD07805/47 gel vehicle.
During each treatment period (baseline to Day 15):
CD07805/47 gel 0.5%, topical, once daily and CD07805/47 gel vehicle, topical, once daily
azelaic acid gel 15%Drug
Also called Finacea® gel 15%
During each treatment period (baseline to Day 15): azelaic acid gel 15%, topical, twice daily

Study groups in NCT01659853
Study group	Role	What they receive
Overall Study	Experimental	In this crossover study of CD07805/47 gel 0.5%/CD07805/47 Vehicle and azelaic acid gel 15%, 70 subjects were randomly assigned to treatment sequence. During Period 1 (15 days), 35 subjects received topical CD07805/47 gel 0.5% in the morning and topical CD07805/47 gel vehicle in the evening, and 35 received topical azelaic acid gel twice daily according to FDA approved prescribing information. Subjects crossed over to the other treatment in Period 2 (15 days). Receives: Drug: CD07805/47 gel 0.5%/CD07805/47 Vehicle; Drug: azelaic acid gel 15%

What is being measured

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

Composite Success
Composite Success, defined as a 2-grade improvement at 6 hours on both the clinician's and subject's erythema assessments at the end of each treatment period
Measured: Hour 6 on Day 15

Secondary outcomes (1)

Onset of Action
Onset of action, defined as an improvement on both the clinician's and subject's erythema assessments at 30 minutes post baseline application
Measured: 30 minutes after baseline treatment application on Day 15

Timeline

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

Sep 2012Dec 2012

First posted8 Aug 2012 (estimated)
Study startSep 2012
Primary completionDec 2012
Study completionDec 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 ErythemaStudies of the same condition, open and under way.
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: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01659853
Sponsor's protocol ID: US10219
Status last verified: Mar 2014
First submitted: 6 Aug 2012
Last updated: 25 Aug 2022
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?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Controlled, Double-masked, Crossover Design Study to Compare Efficacy and Assess Safety of CD07805/47 Gel 0.5% Applied Once Daily vs Azelaic Acid Gel 15% Applied Twice Daily in Subjects With Erythema of Rosacea
ClinicalTrials.gov ID: NCT01659853
Acronym / sponsor ID: US10219
Conditions: Erythema, Rosacea
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: Sep 2012
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 8 Aug 2012 (estimated)
Results: Posted 10 Jul 2014

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 1

Arm	Type	Receives
Overall Study	Experimental	Drug: CD07805/47 gel 0.5%/CD07805/47 Vehicle, Drug: azelaic acid gel 15%In this crossover study of CD07805/47 gel 0.5%/CD07805/47 Vehicle and azelaic acid gel 15%, 70 subjects were randomly assigned to treatment sequence. During Period 1 (15 days), 35 subjects received topical CD07805/47 gel 0.5% in the morning and topical CD07805/47 gel vehicle in the evening, and 35 received topical azelaic acid gel twice daily according to FDA approved prescribing information. Subjects crossed over to the other treatment in Period 2 (15 days).

Who may qualify

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

Key inclusion criteria (5 listed)

Subject is male or female aged 18 years or older.
Subject has a clinical diagnosis of facial rosacea.
Subject has a clinician's assessment score of moderate to severe erythema prior to enrollment.
Subject has a self assessment score of moderate to severe redness prior to enrollment.
Subjects with none to mild facial inflammatory lesions of rosacea prior to enrollment.

Key exclusion criteria (5 listed)

Female subjects who are pregnant, nursing or planning a pregnancy during the study.
Subjects with a condition or who are in a situation, which in the Investigator's opinion may put a subject at risk, may confound study results, or may interfere with a subject's participation in the study.
Subjects with conditions causing facial erythema which would confound the assessment of treatment.
Subjects who are taking or have recently taken medications known to have interactions with α2-adrenergic agonists.
Subjects with known allergies or sensitivities to one of the components of the investigational products.

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%/CD07805/47 VehicleAlso: brimonidine tartrate gel 0.5%, brimonidine tartrate gel vehicleTo maintain masking, CD07805/47 gel 0.5% will be administered along with CD07805/47 gel vehicle. During each treatment period (baseline to Day 15): CD07805/47 gel 0.5%, topical, once daily and CD07805/47 gel vehicle, topical, once daily	Drug	Overall Study
azelaic acid gel 15%Also: Finacea® gel 15%During each treatment period (baseline to Day 15): azelaic acid gel 15%, topical, twice daily	Drug	Overall Study

Primary outcome

Composite Success
Time frame: Hour 6 on Day 15
Composite Success, defined as a 2-grade improvement at 6 hours on both the clinician's and subject's erythema assessments at the end of each treatment period

1 secondary outcome

Onset of Action
Time frame: 30 minutes after baseline treatment application on Day 15

Results and safety

Results posted to the registry on 10 Jul 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% and Vehicle, Then Azelaic Acid Gel 15%	35	35
Azelaic Acid Gel 15%, Then CD07805/47 Gel 0.5% and Vehicle	35	35

Primary outcome: Composite Success

Time frame: Hour 6 on Day 15. Number. Unit: percentage of subjects

Measure	CD07805/47 Gel 0.5% and Vehicle n = 35	Azelaic Acid Gel 15% n = 35
Value	14.3	5.7

Population analysed: A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 15 days. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CD07805/47 Gel 0.5 and Vehicle	0 of 70 (0%)	19 of 70 (27.1%)	Not reported
Azelaic Acid 15%	0 of 68 (0%)	27 of 68 (39.7%)	Not reported

Limitations and caveats (from the sponsor): A significant period effect was observed for CEA indicating there was carryover from period 1 to period 2. Therefore, as stated a priori in the protocol, only data from period 1 were used to analyze efficacy. All safety data are reported.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Ronald W. Gottschalk, MD study director

Galderma R&D

4 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 azelaic acid gel 15% in people with Erythema and Rosacea, run by Galderma R&D at 4 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 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 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 10 Jul 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: Hour 6 on Day 15). 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 NCT01659853.

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 25 Aug 2022; AzTrials last refreshed its copy on 30 Oct 2026.