Atopic Dermatitis (Eczema)NCT06804070
The Effects of a Botanical Moisturizer and an Unscented Soap on Eczema and Itch
A study testing Botanical Moisturizer + Unscented Soap in people with Atopic Dermatitis (Eczema), run by Codex Labs Corporation at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis (Eczema)
- What is being tested?
- Botanical Moisturizer + Unscented Soap
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePoland
- Study dates
- 18 Mar 2024to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Instrumental Efficacy Evaluation on Eczema of One Cosmetic Product
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)
- Being tested
- Botanical Moisturizer + Unscented Soap
- Keywords
- eczema, skin care, botanical, dry skin, itch
- Medical subject headings
- Dermatitis, Atopic, Eczema, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botanical Moisturizer + Unscented SoapOther
The intervention includes the use of 2 products:
- A botanical moisturizer
- An unscented bar of soap
| Study group | Role | What they receive |
|---|---|---|
| Participant | Experimental | 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. Receives: Other: Botanical Moisturizer + Unscented Soap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective and Subjective Scoring of Eczema Severity
Change in eczema severity was assessed using SCORAD (SCOring of Atopic Dermatitis).
- First, the spread of eczema on different body areas is assessed by the investigator and calculated as a percent, where the maximum is 100%.
- 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.
- 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
Measured: 8 weeks
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.
Measured: 4 weeks
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.
Measured: 8 weeks
Secondary outcomes (8)
Skin Hydration
Change in skin hydration is assessed with a Corneometer.
Measured: 4 weeks
Skin Hydration
Change in skin hydration is assessed with a Corneometer.
Measured: 8 weeks
Transepidermal Water Loss
Change in transepidermal water loss is assessed with a Tewameter TM 300
Measured: 4 weeks
Transepidermal Water Loss
Change in transepidermal water loss is assessed with a Tewameter TM 300
Measured: 8 weeks
Desquamation Index
Change in desquamation is assessed with D-Squam®.
Measured: 4 weeks
Desquamation Index
Change in desquamation is assessed with D-Squam®.
Measured: 8 weeks
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.
Measured: 4 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start18 Mar 2024
- Primary completion29 Aug 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (Eczema)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Codex Labs Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804070
- Sponsor's protocol ID
- #STUU524AA0147-1
- Status last verified
- Jan 2025
- First submitted
- 12 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will need to be protected for patentability reasons while IP is being filed. Once IP considerations are finalized, data can be shared.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Instrumental Efficacy Evaluation on Eczema of One Cosmetic Product
- ClinicalTrials.gov ID
- NCT06804070
- Acronym / sponsor ID
- #STUU524AA0147-1
- Conditions
- Atopic Dermatitis (Eczema)
- Keywords
- eczema, skin care, botanical, dry skin, itch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Codex Labs CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant | Experimental | Other: Botanical Moisturizer + Unscented SoapThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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);
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botanical Moisturizer + Unscented SoapThe intervention includes the use of 2 products: 1. A botanical moisturizer 2. An unscented bar of soap | Other | Participant |
Primary outcome
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
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.
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.
8 secondary outcomes
Skin Hydration
Time frame: 4 weeks
Skin Hydration
Time frame: 8 weeks
Transepidermal Water Loss
Time frame: 4 weeks
Transepidermal Water Loss
Time frame: 8 weeks
Desquamation Index
Time frame: 4 weeks
Desquamation Index
Time frame: 8 weeks
Positive and Negative Affect
Time frame: 4 weeks
Positive and Negative Affect
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: No. Data will need to be protected for patentability reasons while IP is being filed. Once IP considerations are finalized, data can be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botanical Moisturizer + Unscented Soap in people with Atopic Dermatitis (Eczema), run by Codex Labs Corporation at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective and Subjective Scoring of Eczema Severity (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.