ClinicalTrials.gg
Sign In
CompletedNCT06819709Updated Feb 11, 2025

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

An interventional study of Botanical Moisturizer + Oral Supplement + Unscented Soap in Atopic Dermatitis (Eczema), sponsored by Codex Labs Corporation. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-11.

Sponsored by Codex Labs Corporation · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Apr 2024, registered Jan 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Atopic Dermatitis (Eczema)

Keywords

  • eczema
  • skin care
  • oral supplement
  • antioxidant
  • l-histidine
  • botanical
  • itch
  • dry skin
03

In context

Dermatitis, Atopic

1,443 studies on the registry are indexed under Dermatitis, Atopic; 253 are open to participants now.

This study's enrollment of 35 is below the median of 83 across 1,143 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Codex Labs Corporation is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Participant

    The participant is provided with and instructed to use a botanical moisturizer on the body and to take an oral supplement 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.

    Other: Botanical Moisturizer + Oral Supplement + Unscented Soap

Interventions

  • OtherBotanical Moisturizer + Oral Supplement + Unscented Soap

    The intervention includes 3 products: 1. A botanical moisturizer 2. An oral supplement containing l-histidine (an amino acid) and antioxidants 3. An unscented bar of soap

06

What researchers measure

Primary outcomes

  1. Objective and Subjective Scoring of Eczema Severity

    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

    Time frame: 8 weeks

  2. Localized Eczema Severity

    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.

    Time frame: 8 weeks

  3. Localized Eczema Severity

    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.

    Time frame: 4 weeks

Secondary outcomes

  1. Skin Hydration

    Change in skin hydration is assessed with a Corneometer.

    Time frame: 4 weeks

  2. Skin Hydration

    Change in skin hydration is assessed with a Corneometer.

    Time frame: 8 weeks

  3. Transepidermal Water Loss

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

    Time frame: 4 weeks

  4. Transepidermal Water Loss

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

    Time frame: 8 weeks

  5. Desquamation Index

    Change in desquamation is assessed with D-Squam®.

    Time frame: 4 weeks

  6. Desquamation Index

    Change in desquamation is assessed with D-Squam®.

    Time frame: 8 weeks

  7. Positive and Negative Affect

    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.

    Time frame: 4 weeks

  8. Positive and Negative Affect

    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.

    Time frame: 8 weeks

07

Study locations

1 site
  • Eurofins Dermscan Poland
    Gdansk, Poland
08

References and documents

Individual participant data

Plan to share: No — Data will need to be protected for patentability reasons while IP is being filed. Once IP considerations are finalized, data can be shared.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2024 to primary completion in Aug 2024, 4 months.

Of 61 industry-sponsored interventional studies with no phase under Dermatitis, Atopic, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 27. This study's 4 months is below that.

Counting every sponsor, half of 163 studies reached it within 16 months; a quarter within 7 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 12, 2025
First posted
Feb 11, 2025
StartActual
Apr 15, 2024
Primary completionActual
Aug 17, 2024
CompletionActual
Sep 2, 2024
Last update
Feb 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06819709
Lead sponsor
Codex Labs Corporation
Collaborators
Eurofins Dermscan Pharmascan
Responsible party
Sponsor
First posted
Feb 11, 2025
Start date
Apr 15, 2024
Primary completion
Aug 17, 2024
Completion
Sep 2, 2024
Last update
Feb 11, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Dermatitis, Atopic →

Other studies from this sponsor

Codex Labs Corporation

Start the discussion