Effects of a Berry Oil Cream on Atopic Eczema and Skin

Atopic Dermatitis Eczema Clinical Trial

Official title:

Effects of a Berry Oil Cream on Atopic Eczema and Skin

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04085549
• Other study ID #: BOAE
• Status: Terminated
• Phase: N/A
• Start date: October 9, 2019
• Est. completion date: April 15, 2020

Study information

• Verified date: January 2021
• Source: Aromtech Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Atopic eczema is a chronic inflammatory skin disease associated with itch and inflammatory lesions in typical skin areas. The objective of this study is to investigate the effects of a cream containing berry and plant oils and humectants on atopic eczema and dry skin.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 83
• Est. completion date: April 15, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

Inclusion Criteria:

• Atopic Eczema (mild or medium severity)

Exclusion Criteria:

• Other serious skin conditions (for example psoriasis)

• Known hypersensitivity to ingredients of the study creams

• Medication seriously affecting immune function

Related Conditions & MeSH terms

• Atopic Dermatitis Eczema
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Device:
• Berry Oil Cream
Cream containing berry and plant oils and humectants; a medical device product in development

Other:
• Reference Cream
Commercial refence cream not containing berry and plant oils.

Locations

Country	Name	City	State
Finland	Mehiläinen (Private Clinic)	Turku

Sponsors (2)

Lead Sponsor	Collaborator
Petra Larmo	Cliniscan Ltd

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in severity of atopic eczema	Objective local Scoring Atopic Dermatitis (SCORAD) index. Scale range for objective local scorad in study part 1 (chosen eczema lesion) 0-63, in study part 2 (body half) 0-73. Decrease indicates better outcome/ milder symptoms.	Part 1: Baseline, 2 weeks. Part 2: Baseline, 5 weeks
Primary	Change in severity of symptoms	Modified Patient Oriented Eczema Measure (POEM) questionnaire. Scale range: 0-24. Decrease indicates better outcome/ milder symptoms.	Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks
Primary	Change in sensation of itch	Visual Analog Scale (VAS) evaluation. Scale range 0-10. Decrease indicates better outcome/ milder symptoms.	Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks
Primary	Change in transepidermal water loss (TEWL)	Measurement of TEWL (g/m2h)	Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks
Primary	Change in skin hydration	Measurement of moisture (capacitance, proportional to water content of skin)	Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks
Primary	Change in skin pH	Measurement of skin pH	Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks
Secondary	Change in symptoms of itching, dryness, flaking of skin	Symptom logbooks: daily scoring from 0 (no symptoms) to 3 (severe symptoms)	Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks