Functional Study to Investigate the Efficacy of a New Medical Device (Modified Diprobase Formulation)

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03672383
• Other study ID #: 19689
• Status: Completed
• Phase: N/A
• Start date: September 17, 2018
• Est. completion date: October 17, 2018

Study information

• Verified date: September 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

Intervention

Device:
• BAY987534
Form: cream; Route of Administration: topical; Frequency of Administration: twice daily ; Duration of Treatment: 4 weeks .

Locations

Country	Name	City	State
Germany	proDerm	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

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

External Links

•   Click here to find results for studies related to Bayer products