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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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17 July 2012 |
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Main ID: |
EUCTR2008-004557-15-DE |
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Date of registration:
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16/09/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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10 days clinical pilot study to investigate the wound healing efficacy of Mirfulan® ointment (containing zinc oxide and cod liver) in an intra-individual comparison with a placebo, zinc oxide and cod liver oil after induction of suction blisters in 22 healthy subjects - Wound healing efficacy of Mirfulan® ointment in a suction blister model
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Scientific title:
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10 days clinical pilot study to investigate the wound healing efficacy of Mirfulan® ointment (containing zinc oxide and cod liver) in an intra-individual comparison with a placebo, zinc oxide and cod liver oil after induction of suction blisters in 22 healthy subjects - Wound healing efficacy of Mirfulan® ointment in a suction blister model |
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Date of first enrolment:
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25/11/2008 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004557-15 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: yes
Other specify the comparator: same as IMP but with only one active substance each
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
•Male or female subjects with healthy skin and skin type I to IV (Fitzpatrick et al. 1974)
•Age 18-55
•Willingness to actively participate in the study and to come to the scheduled visits
•Willingness to discontinue the use of own cleansing and cosmetic products (e.g. soaps, creams, moisturizers) in the treatment areas throughout the course of the study
•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)
•Willingness to avoid extended artificial as well as natural UV light two weeks before the study, during the whole course of the study and at least 3 months after the end of the study
•Willingness to avoid swimming or sauna as well as extreme sporting until the complete re-epithelization of the wounds
•Uniform skin color with no erythema in the test area
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
•Medication
-Systemic treatment with drugs interfering with the immune system:
Corticosteroids, antibiotics 30 days prior to study day 1 and during conduct of study
Antihistamines 30 days prior to study day 1 and during conduct of study
Immunosuppressants 30 days prior to study day 1 and during conduct of study
Antiphlogistics
(minor pain relief medicine like acetaminophene if not more than 1000 mg per day is allowed) 30 days prior to study day 1 and during conduct of study
-Systemic treatment with substances affecting blood coagulation
Acetylsalicylic acid 10 days prior to study day 1 and during the 10 days of the study
Anticoagulants 30 days prior to study day 1 and during conduct of study
Diuretics 30 days prior to study day 1 and during conduct of study
-Topical treatment of test areas*:
Corticosteroids, antibiotics 2 weeks prior to study day 1 and during conduct of study
Anti-inflammatory substances 2 weeks prior to study day 1 and during conduct of study
Pretreatment with any of the test preparations tested in this study 30 days prior to study day 1 and during conduct of study
* moisturizers and sun protection are allowed until 3 days prior to study day 1 but not during the conduct of the study
•Diseases
Atopic dermatitis, eczema and/or sensitive, very dry skin
Active skin disease, e.g. skin tumors
Moderate or severe illness within the last two weeks before first exposure
Known infectious diseases (e.g. hepatitis or AIDS)
•Known hypersensitivity against:
Wool wax alcohol
Hamamelis
Glycerolmonostearate
Other ingredients of the test products
Plaster
•History of keloids and hypertrophic scars
•TEWL before induction of suction blisters > 12 g/m2/h
•pregnancy or lactation
•moles, tattoos, pigmentation or scars on the forearm that would influence the visual scoring
•intensive UV-light exposure within two weeks before the beginning of the test as well as during the study
•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
•any history of severe illnesses in the past 3 years
•subjects with poor compliance
•participation in a clinical trial within the last 30 days prior to the start of this study
•subjects underlying any other restrictions due to the participation in other tests / test institutes
•employees of the study sites or of the Sponsor’s company
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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healthy volunteers
Mirfulan® ointment is a topical formulation for the treatment of wounds. Indications for the application of Mirfulan® are treatment of non-infectious acute and subacute skin damages with erythema, itching and pain.
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Intervention(s)
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Trade Name: Mirfulan
Pharmaceutical Form: Ointment
Other descriptive name: ZINC OXIDE
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 10-
CAS Number: 8001692
Other descriptive name: COD-LIVER OIL
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Ointment
Route of administration of the placebo: Topical use (Noncurrent)
Product Name: Control 1
Pharmaceutical Form: Ointment
CAS Number: 8001692
Other descriptive name: COD-LIVER OIL
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Ointment
Route of administration of the placebo: Topical use (Noncurrent)
Product Name: Control 2
Pharmaceutical Form: Ointment
Other descriptive name: ZINC OXIDE
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Ointment
Route of administration of the placebo: Topical use (Noncurrent)
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Primary Outcome(s)
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Main Objective: The primary objective of the study is to assess the efficacy in wound healing of Mirfulan® ointment in comparison to a placebo and the two ingredients zinc oxide and cod liver oil after induction of wounds (suction blisters). For this purpose TEWL measurements directly after induction of suction blisters will be compared with TEWL measurements at the last study day (day 10). Comparisons between products will be based on a repeated measures ANOVA including one within-subjects factor product.
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Primary end point(s): Primary endpoint:
Comparison of test products based on differences in TEWL (day 10 – day 1)
Secondary endpoints:
Comparison of test products based on TEWL at each assessment timepoint (difference to baseline)
Comparison of test products based on wound area at each assessment timepoint (% changes from baseline)
Comparison of test products based on AUC (TEWL, Wound area)
Comparisons to baseline for each test product (TEWL, Wound area raw data)
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Secondary Objective: •Raw TEWL values at each assessment time point. Comparison of all four test formulations.
•Difference from baseline of TEWL for each product and each assessment time point.
•Area under the curve (AUC) for TEWL ranging from day 1 to day 10
•Raw values of size of wound areas at each assessment time point. Comparison of all four test formulations.
•Comparison of wound areas at baseline with all other assessment time points after application (percent changes (reduction) to baseline will be calculated). Comparison of all four test formulations
•Area under the curve for size of wound area ranging from day 1 to day 10
•Safety parameters will be documented and analyzed
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Secondary ID(s)
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08.0278-38
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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