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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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24 January 2022 |
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Main ID: |
EUCTR2004-001241-14-SE |
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Date of registration:
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21/11/2005 |
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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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Efficacy of the topic RV3131A-HC3221 in the prevention of polymorphic light eruption - Topic RV3131A-HC3221
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Scientific title:
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Efficacy of the topic RV3131A-HC3221 in the prevention of polymorphic light eruption - Topic RV3131A-HC3221 |
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Date of first enrolment:
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19/12/2005 |
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Target sample size:
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45 |
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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:2004-001241-14 |
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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: yes
Single blind: yes
Double blind: no
Parallel group:
Cross over: no
Other: yes
Other trial design description: application areas randomised, investigator masked
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: no treatment applied to one area and vehicle applied to one area
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Phase:
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Human pharmacology (Phase I):
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III):
Therapeutic use (Phase IV):
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Countries of recruitment
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Austria
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Germany
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Sweden
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
· Male or female aged 18-45 with phototype II to IV (Fitzspatrick’s Classification
· History of PMLE
· Negative results to antinuclear antibodies, SS-A (Ro) antibodies and SS-B (La) antibodies searching
· Positive phototest on the control sites
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)
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
· PMLE eruption during the month preceding screening
· Hypersensitivity to test product or vehicle
· Sunburned in the last 3 months or planned sun exposure
· Pregnant or lactating
· Photoprotective treatments, photosensitive treatments, systemic corticosteroids or non steroidal anti inflammatory drug within 4 weeks prior to study start
· Cutaneous lesion or scar in test area
· Likely to develop keloid scars
· Participation in a study within last three months
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Polymorphous Light Eruption
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Intervention(s)
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Product Name: Sunscreen RV3131A HC3221
Product Code: RV3131A HC3221
Pharmaceutical Form: Cream
Pharmaceutical form of the placebo: Cream
Route of administration of the placebo: Topical use (Noncurrent)
Product Name: Sunscreen RV3131A HC3221
Product Code: RV3131A HC3221
Pharmaceutical Form: Cream
Pharmaceutical form of the placebo: Cream
Route of administration of the placebo: Topical use (Noncurrent)
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Primary Outcome(s)
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Main Objective: To evaluate the efficacy of sunscreen RV3131A HC3221 in the prevention of Polymorphic Light Eruption
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Secondary Objective: To evaluate the optimal dose to apply and assess the overall tolerability
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Primary end point(s): The preventive effect of the sunscreen RV3131A HC3221 will be evaluated by the absence of the photodermatosis apparition on the treated sites with a positive control phototest. A phototest will be considered positive if vesicles or papules appear.Clinical assessment of local irritation signs and evaluation of adverse events
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Secondary ID(s)
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2004-001241-14-AT
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V00096 CR 201 – 18 Jun 04
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 19/12/2005
Contact:
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