dermatoporosis stage I and II
Conditions
Interventions
Trade Name: Linoladiol N
Pharmaceutical Form: Cream
Other descriptive name: ESTRADIOL HEMIHYDRATE
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 0.01
Sponsors
Dr. August Wolff GmbH & Co. KG Arzneimittel
Eligibility
Sex/Gender
All
Inclusion criteria
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 24 months prior study start •Serum estradiol =65 years) yes F.1.3.1 Number of subjects for this age range 44
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of test product and placebo on changes of epidermis thickness to baseline after 8 weeks of treatment as measured with a vivascope ;Secondary Objective: •Thickness of epidermis (vivascope) at baseline, after 4 weeks of treatment and follow-up visit •Skin elasticity (Cutometer) at baseline, after 4 and 8 weeks of treatment and follow-up visit •Phase shift rapid in vivo measurements of skin at baseline, after 4 and 8 weeks of treatment and follow-up visit •Thickness of skin (22MHz ultrasound) at baseline, after 4 and 8 weeks of treatment and follow-up visit •Clinical assessment of skin atrophy (investigator) •Changes in senile purpura, pseudo scars and if applicable skin laceration •Tolerability assessed after 2, 4, 6 and after 8 weeks of treatment by study personnel and patient •Self assessment of skin fragility •Skin histology •Laboratory parameters: FSH, LH and estradiol at baseline, after 12, 14 and 16 days of treatment as well as after 8 weeks of treatment •Explorative: count of papillae (Vivasope), if possible, at baseline, after 4 and 8 weeks of treatment and at the follow-up visit •Safety parameters ;Primary end point(s): Change of epidermal thickness to baseline measured after 8 weeks of treatment with a vivascope.;Timepoint(s) of evaluation of this end point: after 8 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Change of epidermal thickness to baseline measured after 4 weeks of treatment and after 12 weeks (follow-up visit) with a vivasope •Changes of skin elasticity parameter R7 (Ur/Uf: elastic relaxation to total elasticity) to baseline after 4 and 8 weeks of treatment and at the follow-up visit (after 12 weeks) measured with Cutometer •Morphological structure of skin: Changes for parameters Rz, Ra to baseline, after 4 and 8 weeks of treatment and at the follow-up visit (after 12 weeks) measured with PRIMOS •Changes in skin thickness to baseline, as measured with by 22MHz ultrasound after 4 and 8 weeks of treatment and at the follow-up visit (after 12 weeks) •Clinical assessment of skin atrophy (investigator), at baseline, 4 and 8 weeks after treatment and at final visit •Changes in senile purpura, pseudo scars and if applicable skin laceration (clinical photography at baseline and after 8 weeks of treatment) •Tolerability assessed after 2, 4, 6 and after 8 weeks of treatment by study personnel and patient •Self assessment of skin fragility by patients once weekly •Skin histology (PE, 4 mm punch biopsy at baseline and after 8 weeks of treatment): Immunohistochemistry: HE (tissues), collagen I + III, EVG •Laboratory parameters: FSH, LH and estradiol at baseline, after 12, 14 and 16 days of treatment as well as after 8 weeks of treatment •Safety parameters (e.g. adverse events, blood safety parameters) ;Timepoint(s) of evaluation of this end point: after 8 weeks of treatment | — |
Countries
Germany
Contacts
Public ContactSabine Müller-Röhr
Dr. August Wolff GmbH & Co. KG
Outcome results
None listed