Papulopustular rosacea MedDRA version: 14.0 Level: PT Classification code 10039218 Term: Rosacea System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Solaraze® 3% gel
Product Code: CD08100/02
Pharmaceutical Form: Gel
INN or Proposed INN: DICLOFENAC SODIUM
CAS Number: 15307-79-6
Current Sponsor code: CD08100/02
Concentration unit: % perc
Sponsors
Galderma R&D SNC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject is a male or female adult aged of at least 18 years; 2. The subject presents with moderate to severe PPR characterized by the presence of at least 15 inflammatory lesions (papules and/or pustules) on the whole face except the central part of the face (nose, chin and middle forehead); Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. The subject has a particular form of rosacea or rosacea like syndrome: severe forms (rosacea conglobata or fulminans), corticosteroid induced rosacea or isolated pustulosis of the chin, facial erythrosis of known origin other than rosacea (known carcinoid syndrome, dysthyroidism, mastocytose, serotonin syndrome, lupus erythematosis) or peri-oral dermatitis; 2. The number of inflammatory or non inflammatory lesions on one half-face is greater than twice the number on the other half-face. 3. The subject has a severe erythema (grade more or equal to 3) or an erythema that, according to the Investigator, does not allow distinguishing papules and pustules.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy objective: To evaluate the efficacy of CD08100/02 3% gel versus placebo gel after a 6-week treatment period in subjects presenting with moderate to severe PPR . ;Secondary Objective: Safety objective: To evaluate the safety of CD08100/02 3% gel by adverse events (AE) reporting, physical examination and vital signs.;Primary end point(s): Efficacy;Timepoint(s) of evaluation of this end point: At baseline and at each evaluation visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety;Timepoint(s) of evaluation of this end point: At baseline and at each visit | — |
Countries
Germany
Contacts
Public ContactCTA Coordinator
Galderma R&D SNC
Outcome results
None listed