Studies performed as of April 29, 2020

Schenefeld, April 29, 2020

The Covid-19 pandemic has a massive impact with regard to the conduct of clinical studies. Some studies cannot be performed at the moment, while others can only be conducted with additional and specific safety and hygienic measures in place. We have implemented such measures to a great extent and are now able to perform a variety of studies with possible deviations in timing and budget. As of today, we are able to perform the following studies:

In-vivo Clinical Testing

  • In Vivo SPF Determination
  • Studies on vulnerable population (no studies with young children and babies)
  • Oral Care Studies
  • Tolerability Testing
    • Epicutaneous Patch Testing
    • Use Tests
  • Efficacy testing
    • Anti-Aging
    • Anti-Pollution (Smoke and PM)
    • Barrier Protection and Recovery
    • Tailored studies with efficacy measurements:
      • Preferably studies with low number of subjects per day
      • Preferably studies with short treatment periods
  • Wound Healing depending on the design
  • Sweat Odor Testing (Sniff Evaluation directly in axilla)
  • Microbiome Studies
  • Raman Studies
  • Use Test for Eye Tolerability

Remote Trials or Virtual Trials

  • Home-use tests with questionnaires
  • Use tests with questionnaires and self-assessment
  • Use tests with questionnaires and remote dermatological assessment

Biophysical Hair Testing

  • Conditioning, Detangling, Easy To Comb
  • Smoothness Of Hair Surface
  • Hair Suppleness
  • Repairing Efficacy, Supple/Flexible Hair
  • Color Protection
  • Protection Against Heat, Sun, UV, Damage, Bleaching Or Dyeing
  • Protection and Resistance Broken Hairs
  • Anti-Spliss/Split-Ends After Combing
  • Anti-Frizz
  • Volume-Increasing/Long-Lasting Volume
  • Long-Lasting Curls
  • Strength Of Fixation, Hold (Stiffness, Bending, Elastic)
  • Combability After Styling
  • Anti-Age
  • Anti-Pollution
  • Anti-Static
  • Moisturizing Hair
  • Weather Resistance

In-vivo Clinical Testing Currently NOT Performed

  • Water resistance studies for SPF determination (with limitations)
  • FDA-Hotroom studies for Antiperspirants (with limitations)

proDERM update in relation to SARS-Cov-2/Covid-19

Schenefeld, April 7, 2020

On March 19 we informed you about what measures we had taken in relation to the pandemic.

In the meantime we have been in discussion with many of you. I am very grateful for the positive feedback we have received and your understanding and cooperation to deal with this extremely difficult situation. I highly value your partnership and can assure you that the entire proDERM Team will work extremely hard to continue to provide you with the best and most reliable service.

Today I would like to provide a brief update on where we stand today and how this affects current and future studies.

  • First and foremost, all staff are healthy and have adapted fast to working remotely where possible.
  • We have had one member of staff tested positive for SARS-Cov-2 on return from skiing. But as they went into quarantine directly after their vacation, a cross-infection amongst proDERM staff members was prevented and luckily, the individual only experienced mild symptoms and has now fully recovered.
  • By way of precaution, we sent any staff with even the slightest suspicion of SARS-Cov-2 infection into quarantine until proven negative.
  • Thanks to initiating safety precautions early on, our dedicated staff, reliable volunteers and a great deal of luck we were able to finalize a major ongoing trial according to protocol and to continue other ongoing studies.
  • We are now able to start a small number of new studies by implementing the following safety measures: keeping a distance of 2 m (and/or using physical barriers like plexiglass), staff AND volunteers wearing facial masks, mandatory hand disinfection and regular disinfection of door nobs, etc. Typical studies that qualify are low in subject numbers, do not involve close-up examinations, etc.
  • We have also jump started our capabilities for remote trials and remote examinations. This includes questionnaires, self-assessments, application controls and remote dermatological assessments. More specific information will be published soon.
  • With reduced study activities some of our employees have entered short-time work. We thereby prevented lay-offs and can go back to full scale as soon as study activities can safely be resumed at a more normal pace.

With this externally enforced break there is often time to think ahead. We are pleased to be in discussion with so many of you to plan future projects. This crisis is truly bigger than anything most of us have experienced in our lifetime. I nevertheless feel that we should already look ahead to determine future needs. I therefore invite you to use this time to discuss your current and future study needs with us.

We share with you the hope that we can soon approach a less restricted life and workstyle and wish you, your family, friends and colleagues all the best.

Yours sincerely

Klaus-Peter Wilhelm

Klaus-Peter Wilhelm
Gründer und CEO

proDERM statement in relation to Covid-19

Schenefeld, March 19, 2020

The increasing, extremely dynamic spread of the corona virus has global effects on our life and the economy. Like everyone we experience extreme disruption by this development.

We have already in the very early phase of this Pandemic taken immediate measures to safeguard the health of study participants, employees and visitors, most importantly uplifting hygiene procedures, cancelling meetings and travel and sending part of the staff into home-office.

We are currently reassessing on a daily basis if and how we can continue performing clinical studies in accordance with government guidelines and the precautionary and hygienic measures we have taken (see attachment). Our number one priority has been and still is to finalize those ongoing studies. To make that happen, we had to postpone most studies that had not yet started, especially those with high volunteer numbers. This is to ensure the need for keeping the distance between people and reducing the number of contact points.

We have contacted all Sponsors whose studies are directly affected. If we have forgotten to contact you, please accept our sincere apologies. This was not out of neglect or disrespect but solely due to our capacity. 3 weeks ago we were running on maximum capacity. Within a week we needed to arrange for a coordinated almost shutdown. This has been an exhausting exercise. But it was not only absolutely necessary but as of today successful.

What is the current status? So far all ongoing projects continue almost as planned. Everyone who possibly can is in home-office and our IT manages this manifold increase in VPN-traffic thanks to an excellent infrastructure, broadband internet and last but not least an excellent and dedicated IT-Team.

With all these modifications and safety precautions we now slowly start looking ahead. As of today it is not foreseeable when we can re-start new study activities. We will continue to evaluate the situation very carefully and react in a responsible way.

But most importantly:

  • No one of our team or study participants has yet been infected thanks to early taken safety measures and a great portion of luck
  • The majority of study participants continues to come to their scheduled study visits
  • The spirit of the proDERM-Team is wonderful. The whole team is motivated and works unimaginably hard to do whatever they can do to assure highest quality even in times of crisis
  • We are very confident to manage this crisis and grow stronger
  • We are using some of our ‘free time’ to advance some long-overdue projects

At the same time, we would like to encourage you to look ahead with us and to discuss your current and future study needs with us. Now is the time to plan for re-starting the economy once this worldwide shutdown is over.

Our thoughts are with you, your families and colleagues. We are all in this together and we will all manage this together.

Yours sincerely

Klaus-Peter Wilhelm

Klaus-Peter Wilhelm
Founder and CEO

Download: proDERM measures against Covid-19: