Atopic DermatitisNCT03719742
A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer
A study testing Sponsor Test Products in people with Atopic Dermatitis, run by Burt's Bees Inc. at 1 site in United States.
Trial summary
A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer Under the Supervision of Dermatologist and Pediatrician Read more about this study
- Who is it for?
- Ages 6 months to 7 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Sponsor Test Products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2018to 18 Jan 2019
- 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 6 months to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy, female or male infants/children, aged 6 months through 7 years.
- In generally good health (physical, mental, and social well-being, not merely the absence of disease/infirmity), according to parent/legal guardian report.
- Having Fitzpatrick skin type I-VI (refer to Appendix I: Fitzpatrick Skin Type).
- Having mild to moderate eczema involving 3% to 20% of body surface area, and with EASI score in the range of 1.1 to 20.0, further stratified into the following subgroups:
- Approximately 60% of subjects with clinically determined EASI score of 1.1-7.0 (mild)
- Approximately 40% of subjects with clinically determined EASI score of 7.1 to 20.0 (moderate)
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- Having a parent/legal guardian at least 18 years of age who regularly bathes the child and otherwise cares for the child, and who presents proof of guardianship (eg, insurance card, certificate of residence, or copy of officially issued family registration) at the baseline visit.
- Having a parent/legal guardian willing to provide written informed consent and who can read, speak, write, and understand English.
- Whose parent/legal guardian is willing to sign a photography release.
- Willing, and having a parent/legal guardian who is willing, to cooperate and participate by following study requirements (including those outlined in section 7.3) for the duration of the study and to report any changes in health status or medications, AE symptoms, or reactions immediately.
- Willing to bring in currently used moisturizer and cleanser to visit 1 for documentation by clinic staff.
Who cannot join
- Diagnosed with known allergies to skin care products or ingredient(s) in the test product.
- History of skin cancer within the past 5 years.
- Individuals who have clinically active bacterial, fungal, or viral skin infections or those who have a history of recurrent cutaneous infections, according to subject self-report.
- Individuals whose use of topical corticosteroids or systemic medications for their eczema has not been stable for at least 6 weeks prior to study start. This includes medicines such as hydrocortisone, clobetasol, betamethasone, halobetasol, fluocinide, diflorasone, mometasone, halcinonide, desoximetasone, pimecrolimus, tacrolimus, crisabarole, and fluticasone.
- Having a health condition and/or pre-existing or dormant dermatologic disease on the body (eg, psoriasis, rosacea, acne [severe acne, acne conglobata, nodules, or cysts], seborrheic dermatitis, severe excoriations.) that the Investigator or designee deems inappropriate for participation or could interfere with the outcome of the study.
- Who have observable suntan, scars, nevi, excessive hair, tattoos, or other dermal conditions on the body that might influence the test results in the opinion of the Investigator or designee.
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- Having a history of immunosuppression/immune deficiency disorders (including HIV infection, AIDS, multiple sclerosis, Crohn's disease, rheumatoid arthritis), had an organ transplant (heart, kidney, etc), or currently using oral or systemic immunosuppressive medications and biologics that are not used for the treatment of eczema (eg, azathioprine, belimumab, Cimzia, Cosentyx, cyclophosphamide, cyclosporine, Enbrel, Humira, Imuran, Kineret, mycophenolate mofetil, methotrexate, Orencia, Remicade, Rituxan, Siliq, Simponi, Stelara, Taltz) and/or undergoing radiation or chemotherapy as determined by study documentation.
- Having a disease such as asthma, diabetes, epilepsy, hypertension, hyperthyroidism, or hypothyroidism that is not controlled by diet or medication; experiencing asthma flares or having multiple health conditions.
- Having started a long-term medication within the last 2 months.
- With any planned surgeries and/or invasive medical procedures during the course of the study. Non-invasive planned surgeries will be reviewed for their impact on the study outcome and acceptability by the Investigator or designee.
- Who are currently participating in any other clinical trial at Stephens, another research facility, or doctor's office
- Who have participated in any clinical trial or experimental treatment involving the test area within 4 weeks prior to inclusion into the study at Stephens, at another research facility or doctor's office.
- Infants/children with a history of or exhibiting signs and symptoms of any systemic disease that may interfere with study evaluations (eg, urinary tract infections, significant bowel or urinary congenital malformation).
- Infant/child who has had a recent change in her/his dietary intake or who has had severe diaper rash within 1 week prior to baseline.
- Individuals who have received PUVA therapy for atopic dermatitis within 4 weeks prior to inclusion in the study.
- Individuals who have received phototherapy within 2 weeks prior to inclusion in the study.
- Individuals who have changed the type of moisturizer or cleanser used within the last 6 weeks prior to inclusion in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer Under the Supervision of Dermatologist and Pediatrician
A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer Under the Supervision of Dermatologist and Pediatrician
Read the detailed description
This single-center clinical trial is being conducted to demonstrate that the Sponsor's product does not statistically or clinically worsen eczema scores in children aged 6 months through 7 years after 4 weeks of treatment compared to baseline scores.
Safety and efficacy will be assessed through clinical grading at baseline and week 4. Efficacy will also be assessed through Corneometer and Tewameter measurements at baseline and week 4. Microbiome skin swab sampling will be performed at baseline and week 4. Parents/guardians will complete Patient Oriented Eczema Measure and Family Dermatology Quality of Life Index at baseline and week 4.
- Conditions
- Atopic Dermatitis
- Being tested
- Sponsor Test Products
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sponsor Test ProductsOther
Baby Bee Foaming Cleanser(at least once daily but not more than twice daily), BB Baby Ultra Gentle Lotion (Once immediately after cleansing and again approximately 10-12 hours after cleansing)
| Study group | Role | What they receive |
|---|---|---|
| Sponsor Test Products | Experimental | 1. Baby Bee Foaming Cleanser(at least once daily)
2. BB Baby Ultra Gentle Lotion (twice daily) Receives: Other: Sponsor Test Products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eczema Area Severity Index (EASI)
The primary efficacy endpoint is no worsening of the clinical appearance of atopic dermatitis/eczema as measured by the Eczema Area Severity Index (EASI) at week 4 from baseline. ranges from 0 (no eczema) to 72.
Measured: 4 Weeks
Secondary outcomes (1)
The secondary endpoint is that the sponsors test materials will be well tolerated and well perceived by subject parents/guardians according to the Family Dermatology Quality of Life Index (FDQLI)
Parent/Guardian Quality of Life as evaluated through subject parents/guardians according to the Family Dermatology Quality of Life Index (FDQLI). Scores range from 0-30. Measurement conducted at week 4 from baseline.
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start27 Sep 2018
- Primary completion18 Jan 2019
- Study completion18 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burt's Bees Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stephens & Associates, Inc.
- Responsible party
- Sponsor
- Investigators
- Lily Jiang, PhD, Principal investigator, Stephens & Associates, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719742
- Sponsor's protocol ID
- C18-D097
- Status last verified
- Apr 2019
- First submitted
- 23 Oct 2018
- Last updated
- 19 Apr 2019
- Results posted
- 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 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer Under the Supervision of Dermatologist and Pediatrician
- ClinicalTrials.gov ID
- NCT03719742
- Acronym / sponsor ID
- C18-D097
- Conditions
- Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Burt's Bees Inc.Industry (pharma, biotech, devices)
- Collaborators
- Stephens & Associates, Inc.
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 18 Jan 2019 (actual)
- Study completion
- 18 Jan 2019 (actual)
- First posted
- 25 Oct 2018 (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.
A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer Under the Supervision of Dermatologist and Pediatrician
Detailed description
This single-center clinical trial is being conducted to demonstrate that the Sponsor's product does not statistically or clinically worsen eczema scores in children aged 6 months through 7 years after 4 weeks of treatment compared to baseline scores.
Safety and efficacy will be assessed through clinical grading at baseline and week 4. Efficacy will also be assessed through Corneometer and Tewameter measurements at baseline and week 4. Microbiome skin swab sampling will be performed at baseline and week 4. Parents/guardians will complete Patient Oriented Eczema Measure and Family Dermatology Quality of Life Index at baseline and week 4.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sponsor Test Products | Experimental | Other: Sponsor Test Products1. Baby Bee Foaming Cleanser(at least once daily) 2. BB Baby Ultra Gentle Lotion (twice daily) |
Who may qualify
- Ages
- 6 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Healthy, female or male infants/children, aged 6 months through 7 years.
- In generally good health (physical, mental, and social well-being, not merely the absence of disease/infirmity), according to parent/legal guardian report.
- Having Fitzpatrick skin type I-VI (refer to Appendix I: Fitzpatrick Skin Type).
- Having mild to moderate eczema involving 3% to 20% of body surface area, and with EASI score in the range of 1.1 to 20.0, further stratified into the following subgroups:
- Having a parent/legal guardian at least 18 years of age who regularly bathes the child and otherwise cares for the child, and who presents proof of guardianship (eg, insurance card, certificate of residence, or copy of officially issued family registration) at the baseline visit.
Key exclusion criteria (17 listed)
- Diagnosed with known allergies to skin care products or ingredient(s) in the test product.
- History of skin cancer within the past 5 years.
- Individuals who have clinically active bacterial, fungal, or viral skin infections or those who have a history of recurrent cutaneous infections, according to subject self-report.
- Individuals whose use of topical corticosteroids or systemic medications for their eczema has not been stable for at least 6 weeks prior to study start. This includes medicines such as hydrocortisone, clobetasol, betamethasone, halobetasol, fluocinide, diflorasone, mometasone, halcinonide, desoximetasone, pimecrolimus, tacrolimus, crisabarole, and fluticasone.
- Having a health condition and/or pre-existing or dormant dermatologic disease on the body (eg, psoriasis, rosacea, acne [severe acne, acne conglobata, nodules, or cysts], seborrheic dermatitis, severe excoriations.) that the Investigator or designee deems inappropriate for participation or could interfere with the outcome of the study.
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 |
|---|---|---|
| Sponsor Test ProductsBaby Bee Foaming Cleanser(at least once daily but not more than twice daily), BB Baby Ultra Gentle Lotion (Once immediately after cleansing and again approximately 10-12 hours after cleansing) | Other | Sponsor Test Products |
Primary outcome
Eczema Area Severity Index (EASI)
Time frame: 4 Weeks
The primary efficacy endpoint is no worsening of the clinical appearance of atopic dermatitis/eczema as measured by the Eczema Area Severity Index (EASI) at week 4 from baseline. ranges from 0 (no eczema) to 72.
1 secondary outcome
The secondary endpoint is that the sponsors test materials will be well tolerated and well perceived by subject parents/guardians according to the Family Dermatology Quality of Life Index (FDQLI)
Time frame: 4 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 19 Apr 2019.
- 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.
Lily Jiang, PhD principal investigator
Stephens & Associates, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sponsor Test Products in people with Atopic Dermatitis, run by Burt's Bees 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 11 inclusion and 17 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 19 Apr 2019. 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?
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?
Eczema Area Severity Index (EASI) (time frame: 4 Weeks). 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 19 Apr 2019.