Clinical study to investigate the efficacy and safety of an estradiol containing cream (0.01 % estradiol) in patients with dermatoporosis - Efficacy of estradiol on dermatoporosis

Dr. August Wolff GmbH & Co. KG Arzneimittel0 个研究点开始时间: 2011年6月17日最近更新: 2013年9月16日

适应症

试验速览

暂无简介。

•dermatoporosis stage I or II, i.e at least the presence of the following symptoms: skin atrophy and senile purpura or pseudo scar, otherwise healthy skin
•Skin thickness < 1mm as measured by ultrasound
•Clinical assessment of skin atrophy of = 2
•Postmenopausal women with last menstruation > 24 months prior study start
•Serum estradiol < 30 pg/ml l
•skin type II to IV (Fitzpatrick) , I may be also included
•= 60 years old
•Willingness to actively participate in the study and to come to the scheduled visits
•Signed written informed consent
•Willingness to discontinue the use of own cleansing and cosmetic products in the treatment areas throughout the course of the study
•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 44
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 44

•-Systemic treatment with drugs interfering with the immune system (in brackets: months prior to study day 1 and during conduct of study) : corticosteroids (3), estrogen or gestagen containing drugs or exogenous steroid hormones (1), use of estragen of gestagen injections (6), nonsteroidal anti-inflammatory drugs (0.5; The intake acetylisalicylic acid is permitted if low-dose prophylaxis or occasional intake for minor pain relief), anticoagulant intake (3)
•-Topical treatment of test areas: corticosteroids (3), anti-inflammatory substances (0.5), any of the test preparations tested in this study (1)
•-Diseases: atopic dermatitis, eczema, rosacea, allergic asthma bronchiale, hyper- or hypotension, bradycardia or bradyarrhytmia, tachycardia or tachyarrhythmia, chronic liver disease, estrogen dependent neoplasia, class III, IV or V Papanicolaou smear or evidence of cervical dysplasia, lyomyoma or endometriosis, sickle cell anaemia, osteosclerosis, idiopathic icterus, acute infection, active skin disease, e.g. skin tumors, keloids formation, hypertrophic scarring, moderate or severe illness within the last 2 weeks before first exposure, known infectious diseases, thromboemboembolic disorders or coagulation disorders
•-Known hypersensitivity against: one of the ingredients of the product, latex, local anesthetics or plasters

发起方