Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of the Medical Device 047 TD Dermatitis Cream in Adults and Children With Atopic and Contact Dermatitis Symptoms Confirmed by Clinical Parameters

NCT07056569 | Recruiting

• 1 other identifier: 047 TD - BK2024
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief Summary

The study aims to evaluate and confirm the performance of 047 TD Dermatitis cream in the improvement of eczematous dermatitis and contact dermatitis, throughout a reduction in disease severity and symptoms.

Conditions

Dermatitis, Contact; Dermatitis; Dermatitis, Chronic; Dermatitis, Eczematous; Dermatitis, Atopic Dermatitis

Keywords

Dermatitis; Atopic dermatitis; Contact dermatitis; Eczematous dermatitis

Outcome Measures

Primary Outcomes (1)

• Performance measured by reduction of disease severity and symptoms

  The evaluation and confirmation of the performance of 047\_TD Dermatitis cream in the improvement of eczematous dermatitis and contact dermatitis, through a reduction in disease severity and symptoms at 28 days of treatment, will be assessed by Investigator's Global Assessment (IGA) scores (successful threshold established as reduction of 1 point of the IGA score with respect to baseline value).

  End of treatment - 28 days.

Secondary Outcomes (10)

• Performance measured by reduction of disease severity and symptoms at 14 days

  14 days of treatment

• Eczema improvement assessed by Eczema Area and Severity Index (EASI) score

  Treatment day 14 and treatment day 28

• Pruritus improvement assessed by VAS

  Treatment day 14 and treatment day 28

• Anti-itch effect measured by patient reported assessment

  Day 1 of treatment

• Long lasting itch relief measured by patient reported assessment

  Treatment day 14 and 28

Study Arms (1)

047_TD Dermatitis cream

EXPERIMENTAL

047\_TD Dermatitis cream formulation with a film-forming action intended for relieving dermatitis symptoms will be applied twice a day for 28 days on the affected skin zone.

Device: 047_TD Dermatitis cream twice a day for 28 days

Interventions

047_TD Dermatitis cream twice a day for 28 days DEVICE

047\_TD Dermatitis cream will be applied twice a day for 28 days on the affected skin zone in sufficient amount of cream and let it dry.

047_TD Dermatitis cream

Eligibility Criteria

• Age: 6 Months - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male/ female \> 6 months \< 65 years
• Patient diagnosed AD/CD
• Patient with EASI max \<16
• Patient with IGA 1-3
• Patient in good condition with no serious systemic disease

You may not qualify if:

• Hypersensitivity to any 047\_TD Dermatitis cream ingredients
• Any other skin disease at the target area that would interfere the clinical assessment in the opinion of the investigator
• Any other adjuvant therapy for AD/CD (UV therapy, probiotics, homeopathy etc.) within 30 days before Baseline as well as during the entire study
• Any use of another topical emollient or other established treatment for AD/CD during the study at the site of flares (AD/CD lesions). Exception are usual hygienic products in the diaper area
• A history of currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy
• Drug abuser
• Don't accept to attend the study procedures and processes as outlined in the protocol. Parents don't accept for the subject less 18th years old
• Could not provide written informed consent or parents' informed consent to have their child participate in the study

Sponsors & Collaborators

• Biokosmes Srl: lead

Study Sites (3)

Studio Medico Pigatto Bersani

Milan, 20154, Italy

NOT YET RECRUITING

Poliambulatorio Verona

Verona, 37135, Italy

RECRUITING

Studio Medico

Voghera, 27058, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Dermatitis, Contact; Dermatitis; Bronchiolitis Obliterans Syndrome; Eczema; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypersensitivity, Immediate; Hypersensitivity

Central Study Contacts

Donatella Mariani

CONTACT

+41 79 844 2600; ssu@solarishc.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 9, 2025
• Study Start: June 5, 2025
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)