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Effect of CD07805/47 Gel in Rosacea Flushing

Primary Purpose

Rosacea

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
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
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rosacea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The subject is a male or female, who is at least 18 years of age or older at Screening visit.
  2. 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)
  3. The subject had at least five flushing episodes during the last week before Screening and Baseline visits

Exclusion Criteria:

  1. 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;
  2. The subject has current treatment with monoamine oxidase inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists;
  3. The subject has less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents;

Sites / Locations

  • Galderma Investigational site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

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

Arm Description

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

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.

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.

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.

Outcomes

Primary Outcome Measures

Total Number of Flushes for Each 2-week Period

Secondary Outcome Measures

Full Information

First Posted
November 20, 2014
Last Updated
August 29, 2016
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT02300129
Brief Title
Effect of CD07805/47 Gel in Rosacea Flushing
Official Title
Effect of CD07805/47 Gel in Subjects Presenting With Flushing Related to Erythematotelangiectatic or Papulopustular Rosacea
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total Number of Flushes for Each 2-week Period
Time Frame
Day 22 and Day 36/Early termination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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;
Facility Information:
Facility Name
Galderma Investigational site
City
Hamburg
Country
Germany

12. IPD Sharing Statement

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Effect of CD07805/47 Gel in Rosacea Flushing

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