Effects of a Berry Oil Cream on Atopic Eczema and Skin

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04085549

Enrollment

Registered

2019-09-11

Start date

2019-10-09

Completion date

2020-04-15

Last updated

2021-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis Eczema

Brief 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.

Interventions

DEVICEBerry Oil Cream

Cream containing berry and plant oils and humectants; a medical device product in development

OTHERReference Cream

Commercial refence cream not containing berry and plant oils.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Study has two parts. In part 1 the participants, care provider and outcome assessor know which treatment is given to each skin area. In part 2 participant, care provider, investigator and outcome assessor do not know which treatment is given to each skin area. Masking is done by identical cream tubes.

Eligibility

Sex/Gender

ALL

Age

12 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in sensation of itch	Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks	Visual Analog Scale (VAS) evaluation. Scale range 0-10. Decrease indicates better outcome/ milder symptoms.
Change in severity of atopic eczema	Part 1: Baseline, 2 weeks. Part 2: Baseline, 5 weeks	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.
Change in severity of symptoms	Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks	Modified Patient Oriented Eczema Measure (POEM) questionnaire. Scale range: 0-24. Decrease indicates better outcome/ milder symptoms.
Change in skin pH	Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks	Measurement of skin pH
Change in transepidermal water loss (TEWL)	Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks	Measurement of TEWL (g/m2h)
Change in skin hydration	Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks	Measurement of moisture (capacitance, proportional to water content of skin)

Secondary

Measure	Time frame	Description
Change in symptoms of itching, dryness, flaking of skin	Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks	Symptom logbooks: daily scoring from 0 (no symptoms) to 3 (severe symptoms)

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026