Dermatitis, Atopic Clinical Trial
Official title:
Randomized, Controlled, Observer-blinded, Intra-individual Clinical Trial to Examine the Efficacy and Safety of a New Medical Device (Modified Diprobase Formulation) in Adults With Quiescent Atopic Dermatitis
Verified date | September 2019 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This clinical trial is intended to investigate the efficacy and safety of a medical device compared to untreated on patients with quiescent atopic dermatitis.
Status | Completed |
Enrollment | 42 |
Est. completion date | October 17, 2018 |
Est. primary completion date | October 17, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients being willing and able to provide written informed consent to participate in the study; - Patients with self-reported history of AD (at least one flare up in the past with mild to moderate intensity), but with no flare-up within the last month; - Patients aged between 18 - 65 years; - Corneometer value < 35 a.u (on one volar forearm); - Skin type I-IV (Fitzpatrick et al. 1974); - Patients willing to adhere to trial procedures; - Patients willing to discontinue the use of own cleansing and cosmetic products (e.g. soaps, creams, moisturizers) in test areas 3 days before Day 1 and throughout the course of the trial; - Patients willing to stop smoking 2 hours before the instrumental measurements; - Patients willing not to drink caffeinated beverages 2 hours before the instrumental measurements; - Patients willing to avoid contact with water in the test areas 2 hours before the instrumental measurements; - Negative urine pregnancy test (for female patients of child bearing potential); - Women of child bearing potential have to use reliable methods of contraception with a low failure rate (i.e., less than 1 % per year; implants, injectables, combined oral contraceptives, hormone-based intrauterine-devices, sexual abstinence or vasectomized partner). Exclusion Criteria: - Any other skin disease on the whole body that would interfere the clinical assessment in the opinion of the Investigator; - Intake of drugs interfering with the immune system (e.g. corticosteroids, immunosuppressive drugs and antihistamines) within 30 days before screening as well as during the trial (with exception of routine vaccinations); - Intrarectal or topical corticosteroids (in the test area) within 2 weeks before screening as well as during the trial; - Known allergies to any of the ingredients of the test product; - Any use of another topical emollient or other established treatment for atopic dermatitis in the test area; - Any other adjuvant therapy for atopic dermatitis (UV therapy, probiotics homeopathy etc.); - Patients with a Body Mass Index > 30; - Diabetes mellitus; - Patients who use tanning beds regularly within the past 2 years; - Exposure of the test area to the sun; - Pregnant or lactating women; - Moles, tattoos, pigmentation or scars on the forearms that would influence the instrumental measurements; - Hairy skin on test areas; - Patients with 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; - Patients with any history of drug addiction or alcoholism in the past 3 years; - Patients with expected poor compliance; - Patients, who are inmates of psychiatric wards, prison or state institutions; - Participation in a clinical trial with investigational medicinal products or medical devices within the last 30 days prior to the start of this trial; - Patients underlying any other restrictions due to the participation in other tests / at other test institutes; - Employees of the trial sites or of the Sponsor's company; - Patients that according to the opinion of the Investigator should not participate in the trial for any reason. |
Country | Name | City | State |
---|---|---|---|
Germany | proDerm | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Bayer |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AUC of the skin hydration assessed of treatment with the test product compared to untreated | AUC: Area under the curve | Up to 4 weeks | |
Secondary | AUC of the short term skin hydration | Comparison of the test product to untreated | Day 1 | |
Secondary | Skin hydration by measuring skin capacitance assessed by Corneometry (unit: a.u.) | Comparison of the test product to untreated based on differences to Baseline as well as the comparison to Baseline | Up to 4 weeks | |
Secondary | Skin hydration after treatment by measuring skin capacitance assessed by Corneometry (unit: a.u.) | a.u.: arbitrary units | Up to 4 weeks | |
Secondary | Skin pH | Comparison of the test product to untreated based on the differences to Baseline | Up to 4 weeks | |
Secondary | Transepidermal water loss | Comparison of the test product to untreated based on differences to Baseline for SDS (Sodium dodecyl sulfate) unchallenged and SDS challenged skin | Up to 4 weeks | |
Secondary | Stratum corneum thickness assessed by Raman Spectrometry (unit: µm) | Comparison of the test product to untreated | Up to 8 hours | |
Secondary | Water gradient within stratum corneum assessed by Raman Spectrometry | Comparison of the test product to untreated | Up to 8 hours | |
Secondary | Number of participants with adverse events (AEs) | Up to 4 weeks | ||
Secondary | Compliance check | The diaries will be collected and checked for compliance and completeness of the daily record | Day 29 | |
Secondary | Water content within stratum corneum assessed by Raman Spectrometry (unit: %) | Comparison of the test product to untreated | Up to 8 hours |
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