Clinical study to investigate the efficacy and safety of an estradiol containing cream (0.01 % estradiol) in patients with senile ski

• Conditions: dermatoporosis stage I and II; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2011-002464-24-DE
• Lead Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-17
• Last Update Posted: 16 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

•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

Exclusion Criteria

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified