Center for Clinical Studies (Phase II-IV)
Since 2010, national and international clinical studies (Phase II-IV) have been carried out for new medications/medicinal products in the fields of Dermatology and Aesthetic Medicine in our Center for Clinical Studies.
We contribute to the research of methods of detection and treatment of human disease including ensuring the effectiveness and harmlessness of new procedures.
Our patients in the Study Center are under the personal care of specially trained study personnel, including highly qualified doctors, nurses and medical assistants. Our long-standing, experienced study team works according to all required standards and the safety and rights of study participants are of utmost priority.
We have a fully equipped, modern Center of Studies with purpose-built premises.
Our doctors are for the most part specialists in Dermatology and have extensive experience in carrying out clinical studies.
Study assistants are medically skilled technicians, nurses or certified study nurses, who are also able to demonstrate many years of clinical study experience.
All the members of the validation group are trained in the ICH-GCP standards for medication clinical studies and GCP-ISO14155 standards for medical product clinical studies. Refresher courses take place regularly every two years.
We comply with the highest quality standards (e.g. SOP’s, intern evaluations, etc.). Audits and inspections are continually passed successfully without serious shortcomings.
There is high patient recruitment potential due to a large catchment area and advertising (Facebook, flyers, newspaper advertisements) and inquiries from interested test persons from our database.
Study Center Equipment:
- 2 separate lockable study office and examination rooms for carrying out visits, storing study medication and current study documentation (cabinets are also lockable)
- 1 separate treatment room for injections and hypodermics
- 1 waiting room
- 1 archives for storing study files (equipped with fire alarm, extinguisher, protected from solar radiation/water damage, air-conditioned, lockable and with entry control)
- 1 separate monitor room with WIFI access
- 2 refrigerator with temperature controls (min. – max. thermometer)
- 2 freezer -20 °C, with temperature controls (min. – max. thermometer)
- Air conditioning with constant temperature
- 1 centrifuge
- 1 special accuracy weighing machine
- Blood pressure monitor, thermometer, body weight scale, height measurement equipment
- Computer for entering eCRF’s
- Fax machine
- High speed internet connection
Form of patient files: digital files. Inspection for monitoring purposes possible at any time in the presence of the study assistant.
Study title CAIN457ADE08 / Metabolyx
Investigational Product Cosentyx (Secukinumab) 4-wöchentlich 300mg s.c.
Objective Efficacy of secukinumab in combination with lifestyle intervention compared to secukinumab without lifestyle intervention.
Study design Randomised, open label, parallel group design, 28 weeks + 28 weeks extension phase
Study title CNTO1959PSO3012 / Janssen GUIDE
Investigational Product Tremfya (Guselkumab)
Objective Evaluation of further therapeutic strategies with guselkumab
Study design Randomised, double-blind, parallel group design
Study title ABY-035-002 / Affibody
Investigational Product ABY-035
Objective Dose finding and efficacy, safety, tolerability and pharmacokinetics of ABY-035
Study design Randomised, placebo-controlled, double-blinded
Study title M-14745-41
Investigational Product 16 weeks with DMF (Skilarence), then with tildrakizumab (Illumetri)
Objective To evaluate the efficacy of tildrakizumab in moderate to severe plaque psoriasis patients who do not respond to DMF.
Study design Open-label, randomised trial
Study title CB-03-01/35/ Cassiopea
Investigational Product The trial includes the following four investigational medicinal products:
1. CB-03-01 (cortexolone-17α-propionate) solution, 5.0%.
2. CB-03-01 (cortexolone-17α-propionate) solution, 7.5%.
3. minoxidil solution 2% (active control).
4. placebo solution (placebo control).
Objective Evaluation of the efficacy and safety of CB-03-01 solution at doses of 5.0% and 7.5% compared with minoxidil solution 2% and the placebo solution for the treatment of androgenetic alopecia for females.
Study design Multi-centre, prospective, randomised, double-blind, minoxidil- and vehiclecontrolled, dose-ranging study.
Study title M930061001 / Merz BCheek
Investigational Product VP 1 Lido US (Belotero Volume Lidocain). Restylane Lyft Lidocaine (Comparator device)
Objective Safety and efficacy of the medical device VP1 Lido US compared to an approved dermal filler
Study design A prospective, multicentre, randomised, comparator-controlled, evaluator-blinded study.
Study title M602011070 /Merz Botox
Investigational Product Clostridium botulinum neurotoxin type A, Bocouture®)
Objective Evaluation of the efficacy and safety of NT 201 in the simultaneous treatment of wrinkles of the upper facial region (horizontal forehead wrinkles, glabellar wrinkles and lateral eyelid wrinkles).
Study design A prospective, randomised, placebo-controlled, multicentre, double-blind study with an open label extension period.
Study title 19E2031 / Hallura
Investigational Product HLR gel in three different concentrations
Objective Volume deficit in the midface, volume deficit of the lips, correction of the nasolabial folds. Safety and performance of the investigational product in the three different concentrations.
Study design Not randomised, open label
Study title MT10109L-004 / Allergan
Investigational Product MT10109L (NivobotulinumtoxinA)
Objective Safety evaluation of MT10109L (nivobotulinumtoxinA) for the treatment of glabellar and lateral canthal lines
Study design A long-term, multicentre, open-label study to evaluate the safety of MT10109L (nivobotulinumtoxinA).
Contact for Patients
Are you interested in taking part in one of our current studies or want to be entered into our database for future studies?
We are continually on the lookout for new study participants.
We would be happy to make ourselves available to answer any of your questions.
Address: Huschbergertsr. 20 40212 Düsseldorf
Participation in a clinical study is voluntary and free of cost. Most of the time we also reimburse your travel costs or any reasonable, related expenses.
Contact for Sponsors
Are you a sponsor or CRO and looking for a qualified center of studies with experience in the fields of Dermatology or Aesthetics?
We have a large pool of potential test persons and have excellent recruiting results.