Erythematotelangiectatic RosaceaPhase 2NCT00989014
Dose-Finding Study of CD07805/47 Topical Gel in Subjects With Erythematotelangiectatic Rosacea
A Phase 2 study testing CD07805/47 in people with Erythematotelangiectatic Rosacea, run by Galderma R&D at 5 sites in United States.
Trial summary
This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel (0.07%, 0.18%, and 0.50%), after a single application in subjects with a clinical diagnosis of stable moderate to severe… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erythematotelangiectatic Rosacea
- What is being tested?
- CD07805/47
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2009to Dec 2009
- 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.
- Clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea.
- CEA (clinician's erythema assessment) score greater than or equal to 3 at Screening and on Treatment visit at baseline.
- PSA (patient self assessment) score of greater than or equal to 3 at Screening and on Treatment visit at baseline.
- Presence of 2 or fewer inflammatory facial lesions.
Who cannot join
- History of Raynaud's Syndrome, glaucoma, orthostatic hypotension, thromboangiitis obliterans, cerebral or coronary insufficiency, or depression.
- History of refractive surgery such as photorefractive keratectomy.
- The subject is being treated with monoamine oxidase (MAO) inhibitor, anti-depressants, barbiturates, opiates, sedatives, systemic anesthetics, alpha-agonists, beta blockers, antihypertensive agents, cardiac glycosides, or systemic anticoagulants.
- The subject is currently enrolled in an investigational drug or device study or participated in such a study in the past 3 months prior to enrollment and is still in the exclusion period on the day of the Treatment visit.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Derm Research, Inc
Austin, Texas, 78759
J&S Studies
College Station, Texas, 77845
Philadephia Institute of Dermatology
Fort Washington, Pennsylvania, 19034
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
The Education & Research Foundation
Lynchburg, Virginia, 24501
About this study
Official title: Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Dose-Finding Study Investigating the Pharmacodynamics and Safety of Three Concentrations of CD07805/47 Topical Gel (0.07%, 0.18%, and 0.50%), Applied in Subjects With Moderate to Severe Erythematotelangiectatic Rosacea
This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel (0.07%, 0.18%, and 0.50%), after a single application in subjects with a clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea. Subjects will be randomized in a 1:1:1:1 ratio to receive either one of three CD07805/47 topical gel concentrations (0.07%, 0.18%, or 0.50%) or Vehicle Gel. All subjects will be treated with a single application (once daily dosing for one day) of study medication.
- Conditions
- Erythematotelangiectatic Rosacea
- Being tested
- CD07805/47, CD07805/47 placebo
- Keywords
- Erythematotelangiectatic, Rosacea
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD07805/47Drug
0.5% Topical Gel
CD07805/47Drug
0.18% Topical Gel
CD07805/47Drug
0.07% Topical Gel
CD07805/47 placeboDrug
Vehicle Topical Gel
| Study group | Role | What they receive |
|---|---|---|
| CD07805/47 0.5% Topical Gel | Experimental | 0.5% Topical Gel Receives: Drug: CD07805/47 |
| CD07805/47 0.18% Topical Gel | Experimental | 0.18% Topical Gel Receives: Drug: CD07805/47 |
| CD07805/47 0.07% Topical Gel | Experimental | 0.07% Topical Gel Receives: Drug: CD07805/47 |
| CD07805/47 Vehicle Topical Gel | Placebo comparator | Vehicle Topical Gel Receives: Drug: CD07805/47 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing.
Measured: Baseline and every hour for 12 hours following application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2009
- Study completionDec 2009
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 Erythematotelangiectatic 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Graeber, MD, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989014
- Sponsor's protocol ID
- RD.06.SPR.18144
- Status last verified
- Sep 2013
- First submitted
- 30 Sep 2009
- Last updated
- 18 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
- Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Dose-Finding Study Investigating the Pharmacodynamics and Safety of Three Concentrations of CD07805/47 Topical Gel (0.07%, 0.18%, and 0.50%), Applied in Subjects With Moderate to Severe Erythematotelangiectatic Rosacea
- ClinicalTrials.gov ID
- NCT00989014
- Acronym / sponsor ID
- RD.06.SPR.18144
- Conditions
- Erythematotelangiectatic Rosacea
- Keywords
- Erythematotelangiectatic, Rosacea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 2 Oct 2009 (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.
This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel (0.07%, 0.18%, and 0.50%), after a single application in subjects with a clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea. Subjects will be randomized in a 1:1:1:1 ratio to receive either one of three CD07805/47 topical gel concentrations (0.07%, 0.18%, or 0.50%) or Vehicle Gel. All subjects will be treated with a single application (once daily dosing for one day) of study medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CD07805/47 0.5% Topical Gel | Experimental | Drug: CD07805/470.5% Topical Gel |
| CD07805/47 0.18% Topical Gel | Experimental | Drug: CD07805/470.18% Topical Gel |
| CD07805/47 0.07% Topical Gel | Experimental | Drug: CD07805/470.07% Topical Gel |
| CD07805/47 Vehicle Topical Gel | Placebo comparator | Drug: CD07805/47 placeboVehicle Topical 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.
- Clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea.
- CEA (clinician's erythema assessment) score greater than or equal to 3 at Screening and on Treatment visit at baseline.
- PSA (patient self assessment) score of greater than or equal to 3 at Screening and on Treatment visit at baseline.
- Presence of 2 or fewer inflammatory facial lesions.
Key exclusion criteria (4 listed)
- History of Raynaud's Syndrome, glaucoma, orthostatic hypotension, thromboangiitis obliterans, cerebral or coronary insufficiency, or depression.
- History of refractive surgery such as photorefractive keratectomy.
- The subject is being treated with monoamine oxidase (MAO) inhibitor, anti-depressants, barbiturates, opiates, sedatives, systemic anesthetics, alpha-agonists, beta blockers, antihypertensive agents, cardiac glycosides, or systemic anticoagulants.
- The subject is currently enrolled in an investigational drug or device study or participated in such a study in the past 3 months prior to enrollment and is still in the exclusion period on the day of the Treatment visit.
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 |
|---|---|---|
| CD07805/470.5% Topical Gel | Drug | CD07805/47 0.5% Topical Gel |
| CD07805/470.18% Topical Gel | Drug | CD07805/47 0.18% Topical Gel |
| CD07805/470.07% Topical Gel | Drug | CD07805/47 0.07% Topical Gel |
| CD07805/47 placeboVehicle Topical Gel | Drug | CD07805/47 Vehicle Topical Gel |
Primary outcome
Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing.
Time frame: Baseline and every hour for 12 hours following application
Results and safety
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.
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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.
Michael Graeber, MD study director
Galderma R&D
5 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 in people with Erythematotelangiectatic Rosacea, run by Galderma R&D at 5 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 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 5 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 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?
Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing. (time frame: Baseline and every hour for 12 hours following application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.