Evaluation of the impact from Polypodium leukotomos Extract on the Prophylaxis of Polymorphic Light Eruption (PMLE) An investigator initiated, prospective, open label study with an in Austria registered nutricional supplement
Conditions
Interventions
Trade Name: Fernblock
Product Name: Fernblock
Pharmaceutical Form: Capsule*
INN or Proposed INN: n.a.
CAS Number: n.a.
Current Sponsor code: Polypodium Leucotomos
Other descriptive name: Fernblock
Con
Sponsors
Univ.Clinic of Dermatology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient selection criteria: Patients with anamnesis and medication according PMLE are invited to take part in this trial. Inclusion criteria: Man and women =18a, =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: Age 65a; other photodermatosis or photosensitive disease; current treatment with systemic corticosteroids, antihistamins, immunsupressiv acting agents; phototherapy or photochemotherapy within the last 8 weeks; participation in another clinical trial; active infections; pregnancy; breast feeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the impact of oral administered poplypodium leucotomos extract on the prophylaxis of polymorphic light eruption (PMLE). Primary criteria: Intensity of skin lesions induced by Photoprovocation: Sum of number of papules, vesicles and plaques. ;Secondary Objective: Secondary criteria: Duration until raise of papules, vesicles and plaques. Intensity of itching. Duration until raising of itching . Intensity of erythema. Duration until raising of eriyhema. ;Primary end point(s): Primary criteria: Intensity of skin lesions induced by Photoprovocation: Sum of number of papules, vesicles and plaques. Study parameters: - Erythema yes/no if yes: slight/medium/severe - Papules yes/no if yes: 1 – 10 / > 10 – 30 / > 30 - Vesicles yes/no if yes: 1 – 10 / > 10 – 30 / > 30 - Plaques yes/no if yes: 1 – 10 / > 10 – 30 / > 30 - Itching tested via Visual Analogue Scale Evaluated will be Intensity and Duration until raise of PMLE läsions during first and second phase of Photoprovocation testing. First testing without second testing under intake of study drug. | — |
Countries
Austria
Outcome results
None listed