healthy volunteers
Conditions
Interventions
Trade Name: Soventol Wund- und Heilgel
Pharmaceutical Form: Gel
Trade Name: Bepanthen Wund- und Heilsalbe
Pharmaceutical Form: Ointment
INN or Proposed INN: Dexpanthenol
Other descriptive name: DEXPA
Sponsors
MEDICE Arzneimittel Pütter GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 • Negative urine pregnancy test (in female subjects of child bearing potential) • Reliable methods of contraception which result in a low failure rate (i.e. less than 1% per year) for women of childbearing potential (implants, injectables, combined oral contraceptives, some intrauterine-devices, sexual abstinence or vasectomised partner) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 36 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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) • Diabetes • 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 • Allergy to the ingredients of the test products • Pregnancy or lactation • Severe illness on account of which the subject should not participate in the study in the opinion of the investigator • Psychiatric conditions that might limit the participation in the trial and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing • Any history of drug addiction or alcoholism in the past 3 years • Infectious diseases • Subjects with expected poor compliance • If in the opinion of the investigator the subject should not participate in the study for any reason • Participation in a clinical trial within the last 30 days prior to the start of this study and during the study conduct • Employees of the study sites or of the Sponsor company • Subjects who are inmates in psychiatric wards, prison or state institutions • Subjects underlying any other restrictions due to the participation in other tests / test institutes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective will be the comparison of the investigational product versus untreated on the size of the open wound area/crusts assessed by image analysis at the different assessment time points (AUC over time on relative differences to baseline). ;Timepoint(s) of evaluation of this end point: not applicable;Secondary Objective: • Comparisons of ref product vs inv product and vs untreated on size of open wound area/crusts • Pair-wise comparisons of the inv product, ref product and untreated area on relative differences to baseline of size of open wound area/crusts. • Comparisons of size of open wound area/crusts at each post-treatment assessment time point vs baseline each treatment separately. • Pair-wise comparisons of inv product, ref product and untreated area on wound margin area • Pair-wise comparisons of inv product, ref product and untreated area on wound margin area at each post-treatment assessment time point. • Pair-wise comparisons of inv product, ref product and untreated area on wound healing assessed by visual scoring • Descriptive statistics for visual assessment scores of inflammation/infection or allergy. • Descriptive statistics for discontinuations. • Descriptive statistics for quantity of product usage. • Documentation and analysis of safety parameters. ;Primary end point(s): The size of the open wound area (including area covered with crusts) will be determined for defined time points by image analysis. The relative difference to baseline will be calculated. AUCs from first to last assessment time point will be calculated with trapezoid formula for the three treatments on these relative differences to baseline. Statistical analysis for the primary objective will be done on the AUC values. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Relative differences to baseline for open wound areas (including area covered with crusts) and actual wound size assessed by image analysis. Original wound margin area ratio to baseline wound size and AUC for original wound margin area ratio to baseline wound size from first to last assessment time point calculated with trapezoid formula for the three treatments. Visual assessment of wound healing at several time points. Inflammation and allergy signs at all time points. ;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Germany
Outcome results
None listed