Healthy subjects will be included in the study. The new generic formulation is intended to be used in the topical treatment of inflammatory processes.
Conditions
Interventions
Product Name: diflorasone
Pharmaceutical Form: Ointment
INN or Proposed INN: DIFLORASONE DIACETATE
CAS Number: 33564317
Concentration unit: % percent
Concentration type: equal
Concentration number: 0.
Sponsors
ALTANA Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following criteria have to be met for inclusion of a subject in the study: • males or females, aged 18 to 50 years; • skin type I to III according to Fitzpatrick; • healthy skin on which reddening can be easily recognized in the area of the test fields; • the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study; • non-tobacco using subjects for 30 days prior to start of study; • sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intrauterine device (IUD), condom with intravaginal spermicide; • written informed consent obtained. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects are to be excluded from the study when one or more of the following conditions are met: • acne, suntan, eczema, hyperpigmentation/hypopigmentation or tattoos in the test fields; • dark-skinned persons whose skin color prevents ready assessment of skin reactions, skin type IV to VI according to Fitzpatrick; • light dermatosis or other hypersensitivity to UVA/B; • multiple dysplastic nevi; • allergy to Fixomull Stretch used in this study; • evidence of drug or alcohol abuse within previous 12 months; • pregnancy or nursing; • symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study; • participation in another clinical trial involving UVB irradiation in the six months preceding the study; • known allergic reactions to components of the study preparations; • treatment with systemic or locally acting medications which might counter or influence the study aim within thirty days before the beginning of the study (e.g. antihistamines or glucocorticosteroids); • use of any concomitant medication with the exception of hormonal contraceptives, medications for regulation of thyroid function, or if necessary paracetamol; • in the opinion of the investigator or physician performing the initial examination the subject should not participate in the study, e.g. due to probable noncompliance or inability to understand the study and give adequately informed consent; • tobacco using subjects within 30 days prior to start of study; • receipt of any drug/device as part of a research study within 30 days prior to initial study dosing; • consumption on average of more than 500mg/day of caffeine per day prior to or during the study (i.e. in beverages).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is the comparison of the efficacy of a generic corticosteroid formulation with the reference listed drug Psorcon® E Emollient Ointment and the comparators Volon® A Salbe ointment and Dermoxin® Salbe ointment on suppression of UV-induced erythema in subjects with healthy skin.;Secondary Objective: n.a.;Primary end point(s): The area under the time-curve (AUC) of the delta a*-values will be analyzed for the reference product Psorcon® Ointment 0.05 %, the comparators Volon® A ointment and Dermoxin® ointment and the IMP Diflorasone Diacetate at 1.5 and 2.0 MED. The primary end point will be the comparison of the AUC for Psorcon® and the IMP Diflorasone Diacetate at that MED with the higher mean for Psorcon®. The other MED will be considered as the secondary analysis. | — |
Countries
Germany
Outcome results
None listed