NCT01119313CompletedPhase 2
A Phase II, Single-center, Randomized, Controlled, Double-blind Study to Assess Effects on Skin Conditions and Patient Reported Outcome of a Topical Formulation Containing LAS41002 on Lesional Skin in Patients With Atopic Eczema
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Almirall, S.A.
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in total sum score of Clinical signs
Study Overview
Brief Summary
The aim of the study is an intra-individual comparison of skin conditions in addition to a patient based assessment of product appearance in the topical treatment of atopic eczema.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •men and women aged 18 years or older;
- •two comparable treatment areas (difference in local SCORAD not greater than 3) on opposite extremities of 100 - 300 cm2 with at least one lesional region within each of these areas of ≥ 20 cm². Clinical condition of atopic eczema mild to moderate defined by a local SCORAD of at least 5 with
- •erythema ≥ 2
- •lichenification ≥ 1
- •dryness ≥ 1
- •itching ≥ 1
- •Erlangen atopy score sum equal or higher than 10 points (3);
- •the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
- •female patients of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices [IUDs], sexual abstinence or vasectomized partner;
- •written informed consent obtained
Exclusion Criteria
- •acne, suntan, eczema, hyperpigmentation or tattoos in the test areas;
- •dark-skinned persons whose skin color prevents ready assessment of skin reactions;
- •evidence of drug or alcohol abuse;
- •pregnancy or nursing;
- •UV-therapy within 6 weeks before first treatment;
- •symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
- •participation in the treatment phase of another clinical study within the last four weeks prior to the first administration of investigational drug in this study;
- •known allergic reactions to components of the study preparations, hypersensitivity against cetostearyl alcohol;
- •treatment with systemic or locally acting medications which might counter or influence the study aim (e.g. antihistamines or glucocorticosteroids) within two weeks before study day 1and throughout the study period (exception: asthma may be found in patients with atopic eczema, therefore inhalation with corticosteroids in patients with asthma accompanying atopic eczema will be allowed at a dose not exceeding 1 mg/day. The dosage should remain constant throughout the study period);
- •contraindications according to summary of product characteristics;
- •in the opinion of the investigator or physician performing the initial examination the patient should not participate in the study, e.g. due to probable noncompliance or inability to understand the study and give adequately informed consent;
- •patient is institutionalized because of legal or regulatory order
Arms & Interventions
LAS 41002
Experimental
Intervention: LAS 41002 (Drug)
Active
Active Comparator
Intervention: Active (Drug)
Outcomes
Primary Outcomes
Change in total sum score of Clinical signs
Time Frame: 15 days
scoring of clinical parameters (erythema, edema, crusting, excoriation, lichenification, dryness, itching) will be performed on a 4 point scale by investigator, comparing data from baseline (day1) vs end of trial (day15)
Secondary Outcomes
- change in skin hydration(15 days)
- Time dependancy of Skin penetration(2 hours)
- patient overall assessment(15 days)
- Number of skin reactions per patient as a measure of safety and tolerability(15 days)
- Number of Adverse Events per patients as a measure of safety and tolerability(Daily)
Investigators
Study Sites (1)
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