EczemaNCT05413395
Assessment of the Effects on the Skin Microbiome of Amending an Over-the-counter Eczema Product With Activated Oil (AO)
A study testing topical colloidal oatmeal formulation with a modified plant oil and topical colloidal oatmeal formulation in people with Eczema, run by GlycosBio, Inc. at 1 site in United States.
Trial summary
This is a single-center, randomized, blinded, controlled trial assessing the effects on the skin microbiome in patients with eczema of amending a standard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation with a modified plant oil ("Activated Oil", AO) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eczema
- What is being tested?
- topical colloidal oatmeal formulation with a modified plant oil and topical colloidal oatmeal formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2022to 1 Mar 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
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female subjects aged who have a recent eczema itch flareup and/or pre-flare-up symptoms at screening as determined by visual analog scale (VAS).
- Diagnosis of mild to moderate eczema (grade 3 - 7 on the Rajka-Langeland severity index).
- Having a target lesion with an ADSI score of 6-12 and an erythema and pruritus subscore of ³2 (moderate).
- Generally good health based on reported history.
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- Able to discontinue all medical and over the counter topical emollients, moisturizers, and / or other skin barrier lotions.
- Females of child-bearing potential should agree to continue using a medically acceptable method of birth control throughout the study and for 30 days immediately after the last dose of study drug.
- Ability to administer topical medication and be willing to adhere to the study interventions.
- Agreement to adhere to Lifestyle Considerations throughout the duration of the study.
Who cannot join
- Pregnancy or lactation.
- Any type of malignancy involving the Study Site Area (Lesion or Non-Lesion site) in the last 5 years.
- Known allergy to hydrocortisone or topical antibiotic.
- Topical or oral use of an antibiotic within the last 7 days prior to baseline clinical visit.
- Bleach bathing in the 7 days prior to Baseline clinical visit.
- Current use of Class I-III topical corticosteroids or systemic medications (e.g. Dupixent) potentially affecting eczema or the skin.
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- Surgeries or invasive medical procedures planned during course of study.
- Suspected non-compliance or non-cooperation.
- Intake of experimental drugs or experimental topical skin treatments within 30 days prior to study start.
- Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subject's participation in or ability to complete the study.
- Diagnosis of human immunodeficiency virus in medical history.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Center for Clinical Studies
Houston, Texas, 77004
Stephen K Tyring, MD, PhD, 713-528-8818
About this study
This is a single-center, randomized, blinded, controlled trial assessing the effects on the skin microbiome in patients with eczema of amending a standard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation with a modified plant oil ("Activated Oil", AO)
- Conditions
- Eczema
- Being tested
- topical colloidal oatmeal formulation with a modified plant oil, topical colloidal oatmeal formulation
- Medical subject headings
- Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical colloidal oatmeal formulation with a modified plant oilOther
Standard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation with a modified plant oil ("Activated Oil", AO). The AO contains proprietary blends of plant oils that have selective antimicrobial properties.
topical colloidal oatmeal formulationOther
Standard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation
| Study group | Role | What they receive |
|---|---|---|
| Protocol | Experimental | Standard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation with a modified plant oil ("Activated Oil", AO) applied to designated "target lesion sites" and "non-lesion sites" (study sites) twice per day for 14 days, followed by a 7-day regression durability period during when no product is applied. Receives: Other: topical colloidal oatmeal formulation with a modified plant oil |
| Control | Active comparator | Standard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation amended with deionized water to match the colloidal oatmeal concentration of the Protocol arm applied to designated "target lesion sites" and "non-lesion sites" (study sites) twice per day for 14 days, followed by a 7-day regression durability period during when no product is applied. Receives: Other: topical colloidal oatmeal formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atopic Dermatitis Severity Index (ADSI) score
Change in mean Atopic Dermatitis Severity Index (ADSI) score from baseline between the protocol and control arms by the 14-day application period. The ADSI comprises an assessment of erythema, pruritus, exudation, excoriation, and lichenification, each on a scale of 0 to 3 to give a maximum score of 15. The maximum score means a worsen condition.
Measured: 14 days
Change in absolute abundance of S. aureus on target lesion site
Difference in reduction in absolute abundance of S. aureus on target lesion site compared to initial absolute abundance at target lesion site (Baseline measurement) between the protocol and control arms by 14-day application period of application period.
Measured: 14 days
Secondary outcomes (4)
Change in relative abundance of S. aureus on non-lesion site
Change in relative abundance of S. aureus on non-lesion site compared to initial relative abundance at target lesion site (Baseline measurement) between the protocol and control arms.
Measured: 14 days
Change in absolute abundance of S. aureus and S. epidermidis on target lesion versus non-lesion site.
Change in absolute abundance of S. aureus and S. epidermidis on the target lesion site compared to the initial absolute abundance of S. aureus and S. epidermidis at the non-lesion site (Baseline measurement) between the protocol and control arms.
Measured: 14 days
Change in Shannon Diversity Index between the target lesion site and non-lesion site
Change in Shannon Diversity Index between the target lesion site compared to the initial Shannon Diversity Index at the non-lesion site (Baseline measurement).
Measured: 14 days
Change in Eczema Area and Severity Index (EASI) score
Change in mean Eczema Area and Severity Index (EASI) score from baseline between the protocol and control arms. An EASI score is a tool used to measure the extent (area) and severity of atopic eczema (Eczema Area and Severity Index). For more information, see Hanifin JM, et al. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group. Exp Dermatol. 2001 Feb;10(1):11-8.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start17 Jun 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EczemaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, randomized, blinded, controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlycosBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Center for Clinical Studies, Texas
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413395
- Sponsor's protocol ID
- GLYCOS-002-AD22
- Status last verified
- Jun 2022
- First submitted
- 7 Jun 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effects on the Skin Microbiome of Amending an Over-the-counter Eczema Product With Activated Oil (AO)
- ClinicalTrials.gov ID
- NCT05413395
- Acronym / sponsor ID
- GLYCOS-002-AD22
- Conditions
- Eczema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- GlycosBio, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Center for Clinical Studies, Texas
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 10 Jun 2022 (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.
This is a single-center, randomized, blinded, controlled trial assessing the effects on the skin microbiome in patients with eczema of amending a standard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation with a modified plant oil ("Activated Oil", AO)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-center, randomized, blinded, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Protocol | Experimental | Other: topical colloidal oatmeal formulation with a modified plant oilStandard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation with a modified plant oil ("Activated Oil", AO) applied to designated "target lesion sites" and "non-lesion sites" (study sites) twice per day for 14 days, followed by a 7-day regression durability period during when no product is applied. |
| Control | Active comparator | Other: topical colloidal oatmeal formulationStandard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation amended with deionized water to match the colloidal oatmeal concentration of the Protocol arm applied to designated "target lesion sites" and "non-lesion sites" (study sites) twice per day for 14 days, followed by a 7-day regression durability period during when no product is applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female subjects aged who have a recent eczema itch flareup and/or pre-flare-up symptoms at screening as determined by visual analog scale (VAS).
- Diagnosis of mild to moderate eczema (grade 3 - 7 on the Rajka-Langeland severity index).
- Having a target lesion with an ADSI score of 6-12 and an erythema and pruritus subscore of ³2 (moderate).
Key exclusion criteria (11 listed)
- Pregnancy or lactation.
- Any type of malignancy involving the Study Site Area (Lesion or Non-Lesion site) in the last 5 years.
- Known allergy to hydrocortisone or topical antibiotic.
- Topical or oral use of an antibiotic within the last 7 days prior to baseline clinical visit.
- Bleach bathing in the 7 days prior to Baseline clinical visit.
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 |
|---|---|---|
| topical colloidal oatmeal formulation with a modified plant oilStandard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation with a modified plant oil ("Activated Oil", AO). The AO contains proprietary blends of plant oils that have selective antimicrobial properties. | Other | Protocol |
| topical colloidal oatmeal formulationStandard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation | Other | Control |
Primary outcome
Atopic Dermatitis Severity Index (ADSI) score
Time frame: 14 days
Change in mean Atopic Dermatitis Severity Index (ADSI) score from baseline between the protocol and control arms by the 14-day application period. The ADSI comprises an assessment of erythema, pruritus, exudation, excoriation, and lichenification, each on a scale of 0 to 3 to give a maximum score of 15. The maximum score means a worsen condition.
Change in absolute abundance of S. aureus on target lesion site
Time frame: 14 days
Difference in reduction in absolute abundance of S. aureus on target lesion site compared to initial absolute abundance at target lesion site (Baseline measurement) between the protocol and control arms by 14-day application period of application period.
4 secondary outcomes
Change in relative abundance of S. aureus on non-lesion site
Time frame: 14 days
Change in absolute abundance of S. aureus and S. epidermidis on target lesion versus non-lesion site.
Time frame: 14 days
Change in Shannon Diversity Index between the target lesion site and non-lesion site
Time frame: 14 days
Change in Eczema Area and Severity Index (EASI) score
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing topical colloidal oatmeal formulation with a modified plant oil and topical colloidal oatmeal formulation in people with Eczema, run by GlycosBio, Inc. at 1 site in United States.
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 10 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 5 Jul 2022. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel J Monticello, Ph.D. ((346) 772-0354, dmonticello@glycosbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atopic Dermatitis Severity Index (ADSI) score (time frame: 14 days). The study lists 2 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 5 Jul 2022.