Erythematotelangiectatic 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 Name: Solaraze®
Pharmaceutical Form: Gel
INN or Proposed INN: DICLOFENAC SODIUM
CAS Number: 15307-79-6
Current Sponsor code: CD08100/02
Concentration unit: % perce
Sponsors
Galderma R&D SNC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - The subject is a male or female adult of at least 18 years old. - The subject presents a moderate to severe ETR 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 25
Exclusion criteria
Exclusion criteria: - The subject has the following forms of rosacea or rosacea like syndrome: papulopustular rosacea, rosacea conglobata or fulminans, corticosteroids-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; - The subject has an underlying disease, surgical or medical condition, which, in the opinion of the investigator • could interfere with evaluations of rosacea itself (e.g., atopic dermatitis, eczema, acne vulgaris); • could put the subject at risk, such as uncontrolled chronic or serious diseases which would normally prevent participation in any clinical trial (such as cancer or AIDS); - The subject has a known past history of hypersensitivity to diclofenac or any of the components of the study products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of CD08100/02 3% gel versus placebo gel after a 4-week treatment period, in subjects presenting with moderate to severe ETR. ;Secondary 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 each evaluation visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety;Timepoint(s) of evaluation of this end point: At each evaluation visit | — |
Countries
Germany
Contacts
Public ContactCTA Coordinator
Galderma R&D SNC
Outcome results
None listed