A monocentric, observer-blind, randomized clinical study using an abrasive wound model with an intra-individual comparison to investigate the wound healing properties of a topical wound healing product in comparison to untreated and a reference product in 36 healthy subjects

Overview

No summary available.

Registry

who.int

Start Date

April 23, 2014

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Men and women
•Age 18 to 55
•Skin type I to III (according to Fitzpatrick et al., 1974\)
•Willingness to actively participate in the study and to come to the scheduled visits
•Willingness to discontinue the application of leave\-on cosmetics (e.g. creams, lotions) and to avoid the use of detergents (e.g. soaps) in the test area throughout the course of the study and 3 days before the start of study
•Willingness to avoid hard physical exercises (with heavy sweating), sauna, swimming and bathing during the test phase
•Willingness to avoid extensive artificial as well as natural UV light on the test areas during the whole course of the study and for at least 3 months after the end of study
•Willingness to avoid contact of the test area with water during the time of patch application (careful showering)
•Uniform skin color and no erythema or dark pigmentation in the test area
•Signed written informed consent to participate in the study

•Active skin disease, moles, tattoos, strong pigmentation and hairy skin at the test area or scars in the test area that would influence the visual scoring
•Psoriasis and/or Lichen ruber and/or atopic dermatitis
•History of keloids and hypertrophic scars
•History of plaster sensitivity
•Intake of drugs interfering with the immune system (e.g. antiphlogistics, corticosteroids, immuno\-suppressants, and antihistamines) within up to 30 days (depending on the kind of therapy) before the start of the study as well as during the study
•Concomitant therapy with substances at doses affecting blood coagulation (e.g. acetylic acid, anticoagulants diuretics, thiazides) within up to 14 days prior to the start of the study as well as during the study
•Topical treatment of the test areas with drugs (e.g. with corticosteroids, antibiotics, anti\-inflammatory substances) within 14 days prior to the start of the study as well as during the study ( moisturizers and sun protection are allowed until 3 days prior)
•Treatment (within up to 14 days prior to the start of the study as well as during the study) with medication of concomitant illnesses which might influence the study (e.g. diabetes, dysfunction of blood clotting)
•Intensive UV\-light exposure within two weeks before the start of the study as well as during the study at the test areas
•Removal of axillary lymph nodes