manifest atopic dermatitis diagnosed according to Hanifin and Rajka, or seborrheic eczema or stasis dermatitis MedDRA version: 14.1 Level: PT Classification code 10041955 Term: Stasis dermatitis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 14.1 Level: LLT Classification code 10062813 Term: Seborrheic eczema System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 14.1 Level: LLT Classification code 10003641 Term: Atopic ecz
Conditions
Interventions
Product Name: Soventol HydroCort 1% cream
Pharmaceutical Form: Cream
INN or Proposed INN: Hydrocortisone
Other descriptive name: HYDROCORTISONE
Concentration unit: mg/g milligram(s)/gram
Concentration
Sponsors
MEDICE Arzneimittel Pütter GmbH & Co.KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • men and women aged 18 years or older; • manifest atopic dermatitis diagnosed according to Hanifin and Rajka, or seborrheic eczema or stasis dermatitis; • two comparable lesional areas of at least 2 cm2, with the clinical condition of atopic eczema or seborrheic eczema or stasis dermatitis rated mild; • the lesions should be located contralaterally for patients with atopic eczema and stasis dermatitis; • an erythema score = 1 in both lesional areas; • the physical examination of the skin must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the clinical trial; • female patients of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices [IUDs], sexual abstinence or vasectomized partner; • 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 48 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: • acne, suntan, eczema other than atopic eczema, seborrheic eczema or stasis dermatitis massive hyper- or hypopigmentation or tattoos in the treatment areas; • syphilitic or tuberculous dermatitis, varicella or vaccine reactions; • dark-skinned persons whose skin color prevents ready assessment of skin reactions; • evidence of drug or alcohol abuse; • pregnancy or nursing; • UV-therapy within 6 weeks before first treatment; • symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks before and during the trial; • participation in the treatment phase of another clinical trial within the last four weeks prior to the first administration of investigational drug in this clinical trial; • known allergic reactions to components of the investigational product/s; • treatment with systemic or locally acting medications which might counter or influence the trial aim within four weeks before the baseline visit and during the trial, e.g. antihistamines, medication that influences liver function, or glucocorticosteroids (exception: asthma may be found in patients with atopic dermatitis, therefore inhalation with corticosteroids in patients with asthma accompanying atopic dermatitis will be allowed); • contraindications according to the summary of product characteristics of Soventol® HydroCort 0.5% and Linolacort® Hydro 1.0%; • in the opinion of the investigator or physician performing the initial examination the patient should not participate in the clinical trial, e.g. due to probable noncompliance or inability to understand the trial and give adequately informed consent; • close affiliation with the investigator (e.g. a close relative) or persons working at the trial centers or patient is an employee of sponsor; • patient is institutionalized because of legal or regulatory order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the superiority of Soventol HydroCort 1% cream versus vehicle and to assess safety of Soventol HydroCort 1% cream;Secondary Objective: Clinical assessment of edema/papulation, oozing/crusting, excoriations, scaling and lichenification will be evaluated descriptively following the primary analysis.;Primary end point(s): The primary endpoint is the superiority of IMP versus vehicle with respect to the AUC of baseline corrected erythema scores.;Timepoint(s) of evaluation of this end point: AUC is determined over the whole experimental phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical assessment of edema/papulation, oozing/crusting, excoriations, scaling and lichenification will be evaluated descriptively.;Timepoint(s) of evaluation of this end point: The clinical assessments will be presented descriptively by visit. | — |
Countries
Germany
Contacts
Public ContactClinical Trials Information
bioskin GmbH
Outcome results
None listed