Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of CD07805/47 Gel in Rosacea Flushing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02300129
Recruitment Status : Completed
First Posted : November 24, 2014
Results First Posted : October 20, 2016
Last Update Posted : October 20, 2016
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

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.

Condition or disease Intervention/treatment Phase
Rosacea Drug: CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo Drug: Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo Drug: CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47 Drug: Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47 Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effect of CD07805/47 Gel in Subjects Presenting With Flushing Related to Erythematotelangiectatic or Papulopustular Rosacea
Study Start Date : April 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Experimental: CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo

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

Drug: CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo

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.


Experimental: Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo

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.

Drug: Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo

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.


Experimental: CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47

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.

Drug: CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47

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.


Experimental: Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47

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.

Drug: Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47

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 Measures :
  1. Total Number of Flushes for Each 2-week Period [ Time Frame: Day 22 and Day 36/Early termination ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300129


Locations
Layout table for location information
Germany
Galderma Investigational site
Hamburg, Germany
Sponsors and Collaborators
Galderma R&D

Layout table for additonal information
Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT02300129     History of Changes
Other Study ID Numbers: RD.03.SPR.40225E
First Posted: November 24, 2014    Key Record Dates
Results First Posted: October 20, 2016
Last Update Posted: October 20, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Layout table for MeSH terms
Rosacea
Flushing
Skin Diseases
Skin Manifestations
Signs and Symptoms