RosaceaPhase 2NCT02300129
Effect of CD07805/47 Gel in Rosacea Flushing
A Phase 2 study of Rosacea, run by Galderma R&D at 1 site in Germany.
Trial summary
Phase 2a study to assess the efficacy and safety of CD07805/47 0.5% gel in the prevention of the flush of rosacea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rosacea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to Jun 2014
- 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
- The subject is a male or female, who is at least 18 years of age or older at Screening visit.
- The subject has a clinical diagnosis of mild to moderate erythemato-telangiectatic rosacea or mild to moderate papulo-pustular rosacea according to the National Rosacea Society grading (Wilkin et al., 2004)
- The subject had at least five flushing episodes during the last week before Screening and Baseline visits
Who cannot join
- The subject has 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;
- The subject has current treatment with monoamine oxidase inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists;
- The subject has less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of CD07805/47 Gel in Subjects Presenting With Flushing Related to Erythematotelangiectatic or Papulopustular Rosacea
Phase 2a study to assess the efficacy and safety of CD07805/47 0.5% gel in the prevention of the flush of rosacea.
Read the detailed description
The objectives of this study in rosacea patients (type I\&II) are:
- to demonstrate objectively that CD07805/47 0.5% gel is able to prevent a flush induced by a specific trigger (hot water) in controlled condition;
- to demonstrate that CD07805/47 0.5% gel is able to prevent a flush whatever the trigger in everyday life condition;
- to investigate if reduction in redness is associated with a decrease in skin sensations such as heat, stinging/burning, skin tension and sweating;
- to demonstrate that such efficacy on transient redness and sensations takes place in both populations (rosacea type I and rosacea type II).
This is a single-centre, randomized, Investigator masked, placebo controlled study comprising the following periods:
A screening period of maximum 4 weeks
A one-week treatment phase (Period 1) with 3 sessions using the flush model, every other day.
This Period 1 includes a cross-over design (first and third sessions) and a split face design (second session). During this period, thirty six (36) subjects will receive on site the study drugs as follows (the order of each session being randomized):
- CD07805/47 placebo gel on both sides of the face,
- one side of the face treated with CD07805/47 0.5% gel, the other side treated with the CD07805/47 placebo gel (the allocation of treatment on each half-face will be determined according to a randomization list),
- CD07805/47 0.5% gel on both sides of the face;
A 2-days wash-out period (between Period 1 and Period 2) with no treatment on either side of the face
A 4-week treatment phase (Period 2) corresponding to a cross-over design during which the subjects will apply themselves the study drugs at home on the whole face, once daily 7 days per week.
The subjects will be divided in 2 groups of eighteen (18) subjects and will receive either the CD07805/47 0.5% gel the first 2 weeks and then the CD07805/47 placebo gel or the CD07805/47 placebo gel the first 2 weeks and then the CD07805/47 0.5% gel, according to randomization.
All the subjects taking part into the study will not be randomized separately in the two periods but to the full sequence at the beginning of the clinical trial (same randomization number during all the study), explaining the arms/groups detailed in the section "Arms and Interventions".
Only primary efficacy endpoint: total number of flushes for each 2-week period will be detailed in the outcome measures section.
The other endpoints are secondary or exploratory.
The purpose of Period 1 is to assess whether simpler and shorter designs based on flush induced by a trigger could be as efficient to detect prevention of flush than the more classical and longer design of Period 2.
- Conditions
- Rosacea
- Being tested
- CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo, Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo, CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47, Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47
- 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, CD07805/47+Placebo, Placebo, CD07805/47, PlaceboDrug
Period 1:
1g of CD07805/47 0.5% Gel on full face on Day 1 and 500mg on a half-face on Day 3.
500mg of Placebo Gel on a half-face on Day 3 and 1g on full face on Day 5.
Period 2:
1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks.
1g of Placebo Gel on full face once daily 7 days per week the 2 following weeks.
Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, PlaceboDrug
Period 1:
1g of Placebo Gel on full face on Day 1 and 500mg on a half-face on Day 3.
500mg of CD07805/47 0.5% Gel on a half-face on Day 3 and 1g on full face on Day 5.
Period 2:
1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks.
1g of Placebo Gel on full face once daily 7 days per week the 2 following weeks.
CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47Drug
Period 1:
1g of CD07805/47 0.5% Gel on full face on Day 1 and 500mg on a half-face on Day 3.
500mg of Placebo Gel on a half-face on Day 3 and 1g on full face on Day 5.
Period 2:
1g of Placebo on full face once daily 7 days per week for 2 weeks.
1g of CD07805/47 0.5% Gel on full face once daily 7 days per week the 2 following weeks.
Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47Drug
Period 1:
1g of Placebo Gel on full face on Day 1 and 500mg on a half-face on Day 3.
500mg of CD07805/47 0.5% Gel on a half-face on Day 3 and 1g on full face on Day 5.
Period 2:
1g of Placebo on full face once daily 7 days per week for 2 weeks.
1g of CD07805/47 0.5% Gel on full face once daily 7 days per week the 2 following weeks.
| Study group | Role | What they receive |
|---|---|---|
| CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo | Experimental | Period 1:
Application of 1g of CD07805/47 0.5% Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.
Application of 500mg of Placebo Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design)
Period 2 (cross-over design):
Application of 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks then 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks Receives: Drug: CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo |
| Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo | Experimental | Period 1:
Application of 1g of Placebo Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.
Application of 500mg of CD07805/47 0.5% Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).
Period 2 (cross-over design):
Application of 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks then 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks. Receives: Drug: Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo |
| CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47 | Experimental | Period 1:
Application of 1g of CD07805/47 0.5% Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.
Application of 500mg of Placebo Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).
Period 2 (cross-over design):
Application of 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks then 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks. Receives: Drug: CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47 |
| Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47 | Experimental | Period 1:
Application of 1g of Placebo Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.
Application of 500mg of CD07805/47 0.5% Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).
Period 2 (cross-over design):
Application of 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks then 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks. Receives: Drug: Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Flushes for Each 2-week Period
Measured: Day 22 and Day 36/Early termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2014
- Study completionJun 2014
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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 34 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
- NCT02300129
- Sponsor's protocol ID
- RD.03.SPR.40225E
- Status last verified
- Aug 2016
- First submitted
- 20 Nov 2014
- Last updated
- 20 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of CD07805/47 Gel in Subjects Presenting With Flushing Related to Erythematotelangiectatic or Papulopustular Rosacea
- ClinicalTrials.gov ID
- NCT02300129
- Acronym / sponsor ID
- RD.03.SPR.40225E
- Conditions
- Rosacea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Posted 20 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2a study to assess the efficacy and safety of CD07805/47 0.5% gel in the prevention of the flush of rosacea.
Detailed description
The objectives of this study in rosacea patients (type I\&II) are:
- to demonstrate objectively that CD07805/47 0.5% gel is able to prevent a flush induced by a specific trigger (hot water) in controlled condition;
- to demonstrate that CD07805/47 0.5% gel is able to prevent a flush whatever the trigger in everyday life condition;
- to investigate if reduction in redness is associated with a decrease in skin sensations such as heat, stinging/burning, skin tension and sweating;
- to demonstrate that such efficacy on transient redness and sensations takes place in both populations (rosacea type I and rosacea type II).
This is a single-centre, randomized, Investigator masked, placebo controlled study comprising the following periods:
A screening period of maximum 4 weeks
A one-week treatment phase (Period 1) with 3 sessions using the flush model, every other day.
This Period 1 includes a cross-over design (first and third sessions) and a split face design (second session). During this period, thirty six (36) subjects will receive on site the study drugs as follows (the order of each session being randomized):
- CD07805/47 placebo gel on both sides of the face,
- one side of the face treated with CD07805/47 0.5% gel, the other side treated with the CD07805/47 placebo gel (the allocation of treatment on each half-face will be determined according to a randomization list),
- CD07805/47 0.5% gel on both sides of the face;
A 2-days wash-out period (between Period 1 and Period 2) with no treatment on either side of the face
A 4-week treatment phase (Period 2) corresponding to a cross-over design during which the subjects will apply themselves the study drugs at home on the whole face, once daily 7 days per week.
The subjects will be divided in 2 groups of eighteen (18) subjects and will receive either the CD07805/47 0.5% gel the first 2 weeks and then the CD07805/47 placebo gel or the CD07805/47 placebo gel the first 2 weeks and then the CD07805/47 0.5% gel, according to randomization.
All the subjects taking part into the study will not be randomized separately in the two periods but to the full sequence at the beginning of the clinical trial (same randomization number during all the study), explaining the arms/groups detailed in the section "Arms and Interventions".
Only primary efficacy endpoint: total number of flushes for each 2-week period will be detailed in the outcome measures section.
The other endpoints are secondary or exploratory.
The purpose of Period 1 is to assess whether simpler and shorter designs based on flush induced by a trigger could be as efficient to detect prevention of flush than the more classical and longer design of Period 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo | Experimental | Drug: CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, PlaceboPeriod 1: Application of 1g of CD07805/47 0.5% Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3. Application of 500mg of Placebo Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design) Period 2 (cross-over design): Application of 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks then 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks |
| Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo | Experimental | Drug: Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, PlaceboPeriod 1: Application of 1g of Placebo Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3. Application of 500mg of CD07805/47 0.5% Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design). Period 2 (cross-over design): Application of 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks then 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks. |
| CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47 | Experimental | Drug: CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47Period 1: Application of 1g of CD07805/47 0.5% Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3. Application of 500mg of Placebo Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design). Period 2 (cross-over design): Application of 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks then 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks. |
| Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47 | Experimental | Drug: Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47Period 1: Application of 1g of Placebo Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3. Application of 500mg of CD07805/47 0.5% Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design). Period 2 (cross-over design): Application of 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks then 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The subject is a male or female, who is at least 18 years of age or older at Screening visit.
- The subject has a clinical diagnosis of mild to moderate erythemato-telangiectatic rosacea or mild to moderate papulo-pustular rosacea according to the National Rosacea Society grading (Wilkin et al., 2004)
- The subject had at least five flushing episodes during the last week before Screening and Baseline visits
Key exclusion criteria (3 listed)
- The subject has 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;
- The subject has current treatment with monoamine oxidase inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists;
- The subject has less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents;
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, CD07805/47+Placebo, Placebo, CD07805/47, PlaceboPeriod 1: 1g of CD07805/47 0.5% Gel on full face on Day 1 and 500mg on a half-face on Day 3. 500mg of Placebo Gel on a half-face on Day 3 and 1g on full face on Day 5. Period 2: 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks. 1g of Placebo Gel on full face once daily 7 days per week the 2 following weeks. | Drug | CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo |
| Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, PlaceboPeriod 1: 1g of Placebo Gel on full face on Day 1 and 500mg on a half-face on Day 3. 500mg of CD07805/47 0.5% Gel on a half-face on Day 3 and 1g on full face on Day 5. Period 2: 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks. 1g of Placebo Gel on full face once daily 7 days per week the 2 following weeks. | Drug | Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo |
| CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47Period 1: 1g of CD07805/47 0.5% Gel on full face on Day 1 and 500mg on a half-face on Day 3. 500mg of Placebo Gel on a half-face on Day 3 and 1g on full face on Day 5. Period 2: 1g of Placebo on full face once daily 7 days per week for 2 weeks. 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week the 2 following weeks. | Drug | CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47 |
| Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47Period 1: 1g of Placebo Gel on full face on Day 1 and 500mg on a half-face on Day 3. 500mg of CD07805/47 0.5% Gel on a half-face on Day 3 and 1g on full face on Day 5. Period 2: 1g of Placebo on full face once daily 7 days per week for 2 weeks. 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week the 2 following weeks. | Drug | Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47 |
Primary outcome
Total Number of Flushes for Each 2-week Period
Time frame: Day 22 and Day 36/Early termination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Rosacea, run by Galderma R&D at 1 site in Germany.
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 3 inclusion and 3 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 20 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 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 20 Oct 2016). 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?
Total Number of Flushes for Each 2-week Period (time frame: Day 22 and Day 36/Early termination). 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 20 Oct 2016.