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Completed

NCT Number: NCT06819709

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

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

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Key information

Conditions

Atopic Dermatitis (Eczema) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eurofins Dermscan Poland

Gdansk, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (cutaneous hydration rate < 50 A.U);
  • 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 cutaneous acceptability/efficacy 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).

Treatment and study plan

Botanical Moisturizer + Oral Supplement + Unscented Soap

Other

The intervention includes 3 products:

  • A botanical moisturizer
  • An oral supplement containing l-histidine (an amino acid) and antioxidants
  • An unscented bar of soap

Primary outcomes

  1. Objective and Subjective Scoring of Eczema Severity

    Time frame: 8 weeks

    Change in eczema severity was assessed using SCORAD (SCOring of Atopic Dermatitis).

    A. First, the spread of eczema on different body areas is assessed by the investigator and calculated as a percent, where the maximum is 100%.

    B. Second, the intensity of skin redness, swelling, oozing, scratch marks, skin thickening and dryness is scored by the investigator from 0 to 3, where 0 is none, 1 is mild, 2 is moderate, and 3 is severe.

    C. Finally, for the subjective score, participants are asked to report the intensity of symptoms (itch and sleeplessness) from 0 to 10, where 0 is no itch or no sleeplessness, and 10 is the worst imaginable itch or insomnia sleeplessness.

    The total score of the objective SCORAD is obtained with the following formula: SCORAD = A/5 + 7 B/2 + C

  2. Localized Eczema Severity

    Time frame: 8 weeks

    Change in localized eczema severity is assessed with the Eczema Area and Severity Index (EASI). Skin redness, elevation, scratching, and thickening are assessed by the investigator on a scale of 0 to 3, where 0 is none, 1 is mild, 2 is moderate, 3 is severe. The localized EASI is the sum of these scores.

  3. Localized Eczema Severity

    Time frame: 4 weeks

    Change in localized eczema severity is assessed with the Eczema Area and Severity Index (EASI). Skin redness, elevation, scratching, and thickening are assessed by the investigator on a scale of 0 to 3, where 0 is none, 1 is mild, 2 is moderate, 3 is severe. The localized EASI is the sum of these scores.

Secondary outcomes

  1. Skin Hydration

    Time frame: 4 weeks

    Change in skin hydration is assessed with a Corneometer.

  2. Skin Hydration

    Time frame: 8 weeks

    Change in skin hydration is assessed with a Corneometer.

  3. Transepidermal Water Loss

    Time frame: 4 weeks

    Change in transepidermal water loss is assessed with a Tewameter TM 300

  4. Transepidermal Water Loss

    Time frame: 8 weeks

    Change in transepidermal water loss is assessed with a Tewameter TM 300

  5. Desquamation Index

    Time frame: 4 weeks

    Change in desquamation is assessed with D-Squam®.

  6. Desquamation Index

    Time frame: 8 weeks

    Change in desquamation is assessed with D-Squam®.

  7. Positive and Negative Affect

    Time frame: 4 weeks

    Change in mood is assessed with the PANAS-SF (Positive and Negative Affect Schedule- Short Form).

    Participants are asked to evaluate the degree to which they experienced components of positive and negative affect : Interested, Distressed, Excited, Upset, Strong, Guilty, Scared, Hostile, Enthusiastic, Proud, Irritable, Alert, Ashamed, Inspired, Nervous, Determined, Attentive, Jittery, Active, and Afraid. A 5-point scale was used where 1 is very slightly or not at all, 2 is a little, 3 is moderately, 4 is quite a bit, and 5 is extremely.

  8. Positive and Negative Affect

    Time frame: 8 weeks

    Change in mood is assessed with the PANAS-SF (Positive and Negative Affect Schedule- Short Form).

    Participants are asked to evaluate the degree to which they experienced components of positive and negative affect : Interested, Distressed, Excited, Upset, Strong, Guilty, Scared, Hostile, Enthusiastic, Proud, Irritable, Alert, Ashamed, Inspired, Nervous, Determined, Attentive, Jittery, Active, and Afraid. A 5-point scale was used where 1 is very slightly or not at all, 2 is a little, 3 is moderately, 4 is quite a bit, and 5 is extremely.

Sponsors and collaborators

Lead sponsor

Codex Labs Corporation

Industry

Collaborators

  • Eurofins Dermscan Pharmascan

Registry information

Official study title

Clinical and Instrumental Efficacy Evaluation of One Cosmetic Oral Supplement - Eczema Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 11, 2025
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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