The Effects of a Botanical Moisturizer and an Unscented Soap on Eczema and Itch

NCT ID: NCT06804070

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-18
• Study Completion Date: 2024-10-30

Brief Summary

The purpose of this study is to examine the effects of a botanical moisturizer and an unscented soap on eczema severity, itch, mood, and various skin measures (such as skin hydration) in those with mild to moderate eczema.

Conditions

Atopic Dermatitis (Eczema)

Keywords

eczema; skin care; botanical; dry skin; itch

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participant

The participant is provided with and instructed to use a botanical moisturizer on the body for the duration of the study. The participant is also provided with and instructed to use an unscented soap, in replacement of the participant's usual cleansing product for the duration of the study.

Group Type: EXPERIMENTAL

Botanical Moisturizer + Unscented Soap

Intervention Type: OTHER

The intervention includes the use of 2 products:

1. A botanical moisturizer

2. An unscented bar of soap

Interventions

Botanical Moisturizer + Unscented Soap

The intervention includes the use of 2 products:

1. A botanical moisturizer

2. An unscented bar of soap

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Sex: female and male;
• Age : 18 years old and above;
• Phototype: I to IV;
• Type: Caucasian;
• Subjects with active eczema condition the body (showing flakiness, irritation, itch and intense dryness);
• Subjects with a SCORAD of 25 - 50;
• Subjects with dry skin on the study areas;
• Subject barely wearing makeup;
• Subjects must not take antibiotics and / or apply any antifungal treatments (body/scalp) for 1 month before study start and during the entire study duration;
• No change in hygiene, cosmetics, and make-up habits - except for the product(s) under study - during the entire study duration;
• Subjects agreeing not to change lifestyle habits during the study duration.
• Healthy subject;
• Subject having given her free informed, written consent;
• Subject willing to adhere to the protocol and study procedures;
• Subject with Polish citizenship.

Exclusion Criteria

• For women with childbearing potential: pregnant or nursing woman or woman planning to get pregnant during the study;
• Cutaneous pathology on the study zone (other than eczema);
• Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the study product (the subjects are allowed to use their topical corticosteroids during the study if needed; the information about the treatment and the number of applications must be noted in the daily log);
• Subject having undergone a surgery under general anesthesia within the previous month;
• Excessive exposure to sunlight or UV-rays within the previous month;
• Subject enrolled in another clinical trial during the study period (concerns the studied zones).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurofins Dermscan Pharmascan

INDUSTRY

Sponsor Role: collaborator

Codex Labs Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eurofins Dermscan Poland

Gdansk, , Poland

Countries

Poland

Other Identifiers

#STUU524AA0147-1

Identifier Type: -

Identifier Source: org_study_id