ErythemaPhase 3NCT01882712
Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Persistent Facial Erythema
A Phase 3 study testing CD07805/47 Gel 0.5% in people with Erythema, run by Galderma R&D.
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 for 29 days versus vehicle control, in subjects with moderate to severe chronic persistent vascular facial erythema Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erythema
- What is being tested?
- CD07805/47 Gel 0.5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Sep 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 at screening visit.
- Presence of chronic persistent vascular facial erythema for ≥ 3 months by history.
- A Clinician's Erythema Assessment (CEA) score of ≥3 at Screening and at Pre-dose (T0) on Baseline/Day 1.
- A Patient Self Assessment (PSA) score of ≥3 at Screening and at Pre-dose (T0) on Baseline/Day 1.
Who cannot join
- More than 2 facial inflammatory lesions (papules, pustules, and nodules).
- Presence of areas of significant scaling or crusting on the face.
- Presence of psoriatic lesions on the face.
- Presence of any other dermatological condition of the face that, in the opinion of the Investigator, may significantly interfere with the interpretation of the clinical trial results.
About this study
The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel 0.5% applied topically once daily for 29 days versus vehicle control, in subjects with moderate to severe chronic persistent vascular facial erythema
- Conditions
- Erythema
- Being tested
- CD07805/47 Gel 0.5%, CD07805/47 Gel Placebo
- Medical subject headings
- Erythema
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
CD07805/47 Gel PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| CD07805/47 Gel 0.5% | Experimental | active arm Receives: Drug: CD07805/47 Gel 0.5% |
| CD07805/47 Gel Placebo | Placebo comparator | Comparator arm Receives: Drug: CD07805/47 Gel Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite success on both CEA (Clinician Erythema Assessment ) and PSA (Patient Self Assessment)
2-grade improvement on both CEA and PSA at Hours 3, and 6 after Pre-dose (T0)on Day 29
Measured: Day 29
Secondary outcomes (1)
Composite improvement on both CEA (Clinician Erythema Assessment ) and PSA (Patient Self Assessment)
1-grade improvement on both CEA and PSA at 30 minutes after pre-dose (T0) on Day 1
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Primary completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ErythemaStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882712
- Sponsor's protocol ID
- RD.03.SPR.40191
- Status last verified
- Nov 2014
- First submitted
- 14 Jun 2013
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Persistent Facial Erythema
- ClinicalTrials.gov ID
- NCT01882712
- Acronym / sponsor ID
- RD.03.SPR.40191
- Conditions
- Erythema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Primary completion
- Sep 2015 (estimated)
- First posted
- 20 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel 0.5% applied topically once daily for 29 days versus vehicle control, in subjects with moderate to severe chronic persistent vascular facial erythema
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 0.5% | Experimental | Drug: CD07805/47 Gel 0.5%active arm |
| CD07805/47 Gel Placebo | Placebo comparator | Drug: CD07805/47 Gel PlaceboComparator arm |
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 at screening visit.
- Presence of chronic persistent vascular facial erythema for ≥ 3 months by history.
- A Clinician's Erythema Assessment (CEA) score of ≥3 at Screening and at Pre-dose (T0) on Baseline/Day 1.
- A Patient Self Assessment (PSA) score of ≥3 at Screening and at Pre-dose (T0) on Baseline/Day 1.
Key exclusion criteria (4 listed)
- More than 2 facial inflammatory lesions (papules, pustules, and nodules).
- Presence of areas of significant scaling or crusting on the face.
- Presence of psoriatic lesions on the face.
- Presence of any other dermatological condition of the face that, in the opinion of the Investigator, may significantly interfere with the interpretation of the clinical trial results.
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% | Drug | CD07805/47 Gel 0.5% |
| CD07805/47 Gel Placebo | Drug | CD07805/47 Gel Placebo |
Primary outcome
Composite success on both CEA (Clinician Erythema Assessment ) and PSA (Patient Self Assessment)
Time frame: Day 29
2-grade improvement on both CEA and PSA at Hours 3, and 6 after Pre-dose (T0)on Day 29
1 secondary outcome
Composite improvement on both CEA (Clinician Erythema Assessment ) and PSA (Patient Self Assessment)
Time frame: Day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CD07805/47 Gel 0.5% in people with Erythema, run by Galderma R&D.
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 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: withdrawn, as of the sponsor's last update on 6 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 on both CEA (Clinician Erythema Assessment ) and PSA (Patient Self Assessment) (time frame: Day 29). 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 6 Nov 2014.