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

NCT03672383 | Completed

• 1 other identifier: 19689
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• AUC of the short term skin hydration

  Day 1

• Skin hydration by measuring skin capacitance assessed by Corneometry (unit: a.u.)

  Up to 4 weeks

• Skin hydration after treatment by measuring skin capacitance assessed by Corneometry (unit: a.u.)

  Up to 4 weeks

• Skin pH

  Up to 4 weeks

• Transepidermal water loss

  Up to 4 weeks

Study Arms (2)

BAY987534 (Treated Arm)

EXPERIMENTAL

Subjects with quiescent atopic dermatitis. Right or left volar forearm with test product applied.

Device: BAY987534

Untreated Arm

NO INTERVENTION

Subjects with quiescent atopic dermatitis. Right or left volar forearm without test product applied.

Interventions

BAY987534 DEVICE

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

Also known as: modified Diprobase formulation

BAY987534 (Treated Arm)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

proDerm

Hamburg, 22869, Germany

Location

Related Links

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

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Observer-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 14, 2018
• Study Start: September 17, 2018
• Primary Completion: October 17, 2018
• Study Completion: October 17, 2018
• Last Updated: September 4, 2019

Record last verified: 2019-09

Locations

DE (1)