of Clinical Operation, Medstat Research AS
Palo Alto and Stanford University California;
Post doctoral studies in Clinical Pharmacology Syntex Research Labs.
University of Oslo; Medical studies 1966-1970
University of Oslo; Ph.D. in biochemistry 1966
Summary of Experience:
Main areas of expertise include 30 years experience in clinical trial
management, including design of study protocols. Conducting initial
site visits, monitoring and close-down visits. Therapeutic areas of
expertise include Cardiology, Rheumatology, Neurology, Dermatology,
Nutrition and several Pharmacokinetic studies.
treatment of the ageing symptoms of facial skin
Title: A randomized, placebo-controlled
double blind study on the clinical efficacy of an oral treatment with
Dermavite® of ageing symptoms of the skin.
Study design: Randomised, placebo-controlled double-blind study
with an observation period of 6 months.
Subjects: A total of 44 female subjects were included in the
study 22 participants received DermaVite® while 22 received placebo.
Investigational treatment: The preparation studied (DermaVite®)
is a tablet containing a marine protein, alpha-lipoic acid, Lycopene,
pine-bark extract and vitamins and minerals. The placebo tablet had
an identical appearance and was packed in similar bottles, but did not
contain active ingredients. The dosage was 2 tablets per day.
Performance of the study: Objective measurements, skin thickness
and elasticity, as well as subjective observations, in form of clinical
parameters, were used for evaluation of the effect of the treatments.
In addition the participants made their self-evaluation of the effect,
using Visual Analogue Scales (VAS). Photos were taken initially and
on each of the control visits which took place after 2, 4 and 6 months.
Results: The two treatment groups were comparable at the outset
of the study with respect to the main parameters such as age and grade
of ageing symptoms of the skin. 20 subjects in the each of the two groups
completed the study according to the protocol. The results show a significant
improvement in skin quality both with regard to objective parameters
as well as subjective after treatment with DermaVite®. No significant
treatment effects were detected after treatment with placebo. The participants’
self-evaluation showed a statistical difference in favour of the active
treatment. The majority of the participants taking DermaVite® would
like to continue with the treatment after the study was concluded. The
tolerability’s of the treatments were excellent.