Patients with different dermatological diseases ? Atopic eczema (MedDRA 6.0, LLT: 10003641) ? Dishydrotic hand eczema (MedDRA 6.0, LLT: 10013913) ? Plaque type psoriasis (MedDRA 6.0, LLT: 10050576) ? Seborrheic eczema (MedDRA 6.0, LLT: 10039795) ? Acne vulgaris (MedDRA 6.0, LLT: 10000519) MedDRA version: 6.0 Level: LLT Classification code 10040833
Conditions
Sponsors
IDEA AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: One of the following dermal indications (mild to moderate): ? Atopic eczema in the crook of the arm or hollow of the knee ? Dishydrotic hand eczema ? Plaque type psoriasis (hyperkeratoses removed before treatment by urea or salicylic acid) ? Seborrheic eczema ? Acne vulgaris Aged 18–80 years Reliable method of contraception for women of childbearing potential Are the trial subjects under 18? 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
Exclusion criteria
Exclusion criteria: Systemic therapy for skin diseases within 2 weeks prior to start of treatment except if maintained stable during the whole course of the study and approved by the safety officer UV therapy for dermal indications within 4 weeks prior to start of treatment Chronic or acute illness requiring systemic antiinflammatory treatment except if maintained stable during the whole course of the study and approved by the safety officer Skin cancer and precancerous skin lesions, except basal cell carcinoma (BCC), squamous cell carcinoma (SCC) and actinic keratosis if located outside the target area History of peptic ulcers or gastric intolerance with NSAIDs History of asthma bronchiale History of chronic airway infection History of renal insufficiency Thrombocytopathia Immunosuppressants (e.g., corticosteroids) within 2 weeks prior to start of treatment Known sensitisation to NSAIDs Pregnancy or lactation Mental disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Clinical evaluation of the efficacy of IDEA-070 (ketoprofen in Transfersome®) in patients with different dermatological diseases using the Investigator Global Assessment score (IGA). ;Secondary Objective: 1.Clinical evaluation of the efficacy of IDEA-070 (ketoprofen in Transfersome®) in patients with different dermatological diseases using the following scores: a) Patient Global Assessment score (PGA) b) Indication specific scores (SCORAD, DASI, PASI, GAGS) 2.Safety of IDEA-070 evaluated by a) description of AE profile b) changes in laboratory values c) physical examination d) vital signs including body weight and body temperature e) ketoprofen plasma levels ;Primary end point(s): The primary endpoint will be the investigator global assessment using the Investigator Global Assessment SCORE (IGA) | — |
Countries
Germany
Outcome results
None listed