Effects of a Berry Oil Cream on Atopic Eczema and Skin

NCT04085549 | Terminated

• 1 other identifier: BOAE
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis Eczema

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• Change in transepidermal water loss (TEWL)

  Measurement of TEWL (g/m2h)

  Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks

• 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

• Change in skin pH

  Measurement of skin pH

  Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks

Secondary Outcomes (1)

• Change in symptoms of itching, dryness, flaking of skin

  Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks

Study Arms (3)

Berry Oil Cream

EXPERIMENTAL

Study part 1: Administered to a chosen eczema lesion on randomized body half 1-2 times/d or more frequently (use reported to study logbook) for two weeks. Also administered to forearm (randomized body half) twice/d for two weeks. Study part 2: Administered to randomized body half 1-2 times/d for five weeks.

Device: Berry Oil Cream

Control

NO INTERVENTION

Study part 1: A chosen eczema lesion on randomized body half is an untreated control for two weeks. Also one forearm (on randomized body half) is a control with no treatment for two weeks.

Reference cream

ACTIVE COMPARATOR

A commercial reference cream, not containing berry and plant oils. Study part 2: Administered to randomized body half 1-2 times/d for five weeks.

Other: Reference Cream

Interventions

Berry Oil Cream DEVICE

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

Berry Oil Cream

Reference Cream OTHER

Commercial refence cream not containing berry and plant oils.

Reference cream

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Atopic Eczema (mild or medium severity)

You may not qualify if:

• Other serious skin conditions (for example psoriasis)
• Known hypersensitivity to ingredients of the study creams
• Medication seriously affecting immune function

Sponsors & Collaborators

• Petra Larmo: lead
• Cliniscan Ltd: collaborator

Study Sites (1)

Mehiläinen (Private Clinic)

Turku, Finland

Location

Study Officials

• Risto Oksman, MD

  Cliniscan Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ph.D., R&D Manager

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 11, 2019
• Study Start: October 9, 2019
• Primary Completion: April 15, 2020
• Study Completion: April 15, 2020
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)