Clinical trial NCT03672383: Functional Study to Investigate the Efficacy of a New Medical Device (Modified Diprobase Formulation)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatitis, Atopic
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-09-14
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial is intended to investigate the efficacy and safety of a medical device compared to untreated on patients with quiescent atopic dermatitis.


Eligibility criteria: 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.

Primary outcomes:
measure: AUC of the skin hydration assessed of treatment with the test product compared to untreated
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: AUC of the short term skin hydration
timeFrame: Day 1
measure: Skin hydration by measuring skin capacitance assessed by Corneometry (unit: a.u.)
timeFrame: Up to 4 weeks
measure: Skin hydration after treatment by measuring skin capacitance assessed by Corneometry (unit: a.u.)
timeFrame: Up to 4 weeks
measure: Skin pH
timeFrame: Up to 4 weeks
measure: Transepidermal water loss
timeFrame: Up to 4 weeks
measure: Stratum corneum thickness assessed by Raman Spectrometry (unit: µm)
timeFrame: Up to 8 hours
measure: Water gradient within stratum corneum assessed by Raman Spectrometry
timeFrame: Up to 8 hours
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 4 weeks
measure: Compliance check
timeFrame: Day 29
measure: Water content within stratum corneum assessed by Raman Spectrometry (unit: %)
timeFrame: Up to 8 hours
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: proDerm
Study officials:
References: