Atopic DermatitisPhase 2NCT02691507
Trial to Determine the Therapeutic Benefit of an OTC Cream on Dry, Itchy Skin of Adults and Children With Eczema
A Phase 2 study testing EpiCeram Skin Barrier Emulsion and Experimental Product 1% Colloidal Oatmeal Balm in people with Atopic Dermatitis, run by Johnson & Johnson Consumer Inc. (J&JCI) at 2 sites in United States.
Trial summary
The objective of this 1 week trial is to evaluate the efficacy of an over-the-counter (OTC) 1% colloidal oatmeal skin protectant cream in adults and children with mild to moderate AD. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- EpiCeram Skin Barrier Emulsion and Experimental Product 1% Colloidal Oatmeal Balm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2016to Apr 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates)
- Male or female of any race or ethnicity, ages 12 and older
- Diagnosed as having eczema
- Willing to stop use of all non-assigned moisturizers and/or creams for the entire duration of the study
Who cannot join
- Known sensitivity to any investigational product ingredient
- Females who are pregnant , breastfeeding , or planning on becoming pregnant during the study
- Individuals with a history of skin cancer
- Use of a therapeutic (over-the-counter or prescription) body wash that contains an active ingredient for eczema
- Participation in any clinical study within 30 days of Visit 1
- Active infection of any type at the start of the study
Show all 10Show fewer
- Diagnosed as having severe eczema
- Has a compromised immune system
- Individuals with any planned surgeries and/or invasive medical procedures during the course of the study
- Requires greater than 2.0mg/day inhaled or intranasal corticosteroids
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stephens & Associates (Colorado Research Center)
Colorado Springs, Colorado, 80915
Stephens & Associates (Texas Reserach Center)
Richardson, Texas, 75081
About this study
Official title: A Clinical Trial to Determine the Therapeutic Benefit of an Investigational Over-The-Counter Cream on Dry, Itchy Skin of Adults and Children With Atopic Dermatitis.
The objective of this 1 week trial is to evaluate the efficacy of an over-the-counter (OTC) 1% colloidal oatmeal skin protectant cream in adults and children with mild to moderate AD.
Read the detailed description
Approximately 60 subjects will be enrolled to ensure 52 subjects complete the study (39 subjects: active treatment and 13 subjects: positive control).
Adults and children (ages 12 and over) will receive either a marketed or not yet marketed investigational product for the treatment of eczema. Subjects will be asked to stop use of prescription and all eczema treatments 2 days before the start of the study and during the study. Subjects will apply study product as indicated for 7 days to affected areas.
Subjects will record treatment use in a daily diary and complete questionnaires. A dermatologist will examine and score the eczema and symptoms. Skin moisture levels will also be tested.
- Conditions
- Atopic Dermatitis
- Being tested
- EpiCeram Skin Barrier Emulsion, Experimental Product 1% Colloidal Oatmeal Balm
- Keywords
- Eczema, Itchy Skin
- 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.
EpiCeram Skin Barrier EmulsionDevice
EpiCeram Skin Barrier Emulsion
Experimental Product 1% Colloidal Oatmeal BalmDrug
Also called Eczema Moisturizing Balm
Experimental Product 1% Colloidal Oatmeal Balm
| Study group | Role | What they receive |
|---|---|---|
| Positive Control | Active comparator | Marketed - EpiCeram(R) Skin Barrier Emulsion: Apply in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin. Receives: Device: EpiCeram Skin Barrier Emulsion |
| Experimental | Experimental | Not Yet Marketed - 1% Colloidal Oatmeal Balm: Apply at least once per night or more if needed. Receives: Drug: Experimental Product 1% Colloidal Oatmeal Balm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Itch Assessment Score Immediately Following Treatment
The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.
Measured: Baseline to immediately following treatment
Change From Baseline in the Itch Assessment Score 1 Hour After Treatment
The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.
Measured: Baseline to one hour after treatment
Change From Baseline in the Itch Assessment Score 2 Hours After Treatment
The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.
Measured: Baseline to two hours after treatment
Change From Baseline in the Itch Assessment Score 3 Hours After Treatment
The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.
Measured: Baseline to three hours after treatment
Change From Baseline in the Itch Assessment Score 4 Hours After Treatment
The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.
Measured: Baseline to four hours after treatment
Change From Baseline in the Itch Assessment Score 5 Hours After Treatment
The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.
Measured: Baseline to five hours after treatment
Change From Baseline in the Itch Assessment Score 6 Hours After Treatment
The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.
Measured: Baseline to six hours after treatment
Change From Baseline in the Itch Assessment Score 7 Days After Treatment
The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.
Measured: Baseline to seven days after treatment
Secondary outcomes (55)
Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Measured: Baseline to Immediately following treatment
Change From Baseline in Mean Corneometer Measurement 1 Hour After Treatment
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Measured: Baseline to one hour after treatment
Change From Baseline in Mean Corneometer Measurement 2 Hours After Treatment
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Measured: Baseline to two hours after treatment
Change From Baseline in Mean Corneometer Measurement 3 Hours After Treatment
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Measured: Baseline to three hours after treatment
Change From Baseline in Mean Corneometer Measurement 4 Hours After Treatment
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Measured: Baseline to four hours after treatment
Change From Baseline in Mean Corneometer Measurement 5 Hours After Treatment
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Measured: Baseline to five hours after treatment
Change From Baseline in Mean Corneometer Measurement 6 Hours After Treatment
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Measured: Baseline to six hours after treatment
Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Measured: Baseline to seven days after treatment
Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin
Questions were answered before treatment by the participant. The question is "I'm less distracted by my itchy skin"
Measured: 0 Days - Pre-treatment
Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin
Questions were answered before treatment by the participant. The question is "I wake up to calmer skin"
Measured: 0 Days - Pre-treatment
Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin
Questions were answered before treatment by the participant. The question is "My skin feels smooth"
Measured: 0 Days - Pre-treatment
Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin
Questions were answered before treatment by the participant. The question is "I feel comfortable showing my skin"
Measured: 0 Days - Pre-treatment
Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin
Questions were answered before treatment by the participant. The question is "My skin feels moisturized"
Measured: 0 Days - Pre-treatment
Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin
Questions were answered before treatment by the participant. The question is "My skin feels touchable"
Measured: 0 Days - Pre-treatment
Participant Questionnaire on Day 0 Pre-treatment - Soft Skin
Questions were answered before treatment by the participant. The question is "My skin feels soft"
Measured: 0 Days - Pre-treatment
Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Eczema Skin Over Past 2 Days
Questions were answered before treatment by the participant. The question is "Thinking about your experience over the past two days, please describe your degree of being distracted by your itchy, eczema skin. Would you say you were"
Measured: 0 Days - Pre-treatment
Participant Questionnaire on Day 0 Pre-treatment - Skin Upon Waking Over Past 2 Days
Questions were answered before treatment by the participant. The question is "Thinking about your experience over the past two days, how would you describe your skin upon awakening?"
Measured: 0 Days - Pre-treatment
Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days
Questions were answered before treatment by the participant. The question is "Thinking about how well you slept during the past two days, would you say your sleep was?"
Measured: 0 Days - Pre-treatment
Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days
Questions were answered before treatment by the participant. The question is "Thinking about how comfortable you felt showing your skin during the last two days, would you say that you were"
Measured: 0 Days - Pre-treatment
Participant Questionnaire Immediately After Treatment - Product Fast Absorbing
Questions were answered immediately after treatment by the participant. The question is "This product is fast absorbing"
Measured: 0 Days - Immediately after treatment
Participant Questionnaire Immediately After Treatment - Calm Skin
Questions were answered immediately after treatment by the participant. The question is "This product calms my skin"
Measured: 0 Days - Immediately after treatment
Participant Questionnaire Immediately After Treatment - Moisturized Skin
Questions were answered immediately after treatment by the participant. The question is "This product leaves my skin feeling immediately moisturized"
Measured: 0 Days - Immediately after treatment
Participant Questionnaire Immediately After Treatment - Product Does Not Sting
Questions were answered immediately after treatment by the participant. The question is "This product does not sting when applied"
Measured: 0 Days - Immediately after treatment
Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture
Questions were answered four hours after treatment by the participant. The question is "This product provides long lasting moisture"
Measured: Four hours after treatment
Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft
Questions were answered four hours after treatment by the participant. The question is "This product leaves my skin feeling soft"
Measured: Four hours after treatment
Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture
Questions were answered five hours after treatment by the participant. The question is "This product provides long lasting moisture"
Measured: Five hours after treatment
Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft
Questions were answered five hours after treatment by the participant. The question is "This product leaves my skin feeling soft"
Measured: Five hours after treatment
Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture
Questions were answered six hours after treatment by the participant. The question is "This product provides long lasting moisture"
Measured: Six hours after treatment
Participant Questionnaire 6 Hours After Treatment - Calms Skin
Questions were answered six hours after treatment by the participant. The question is "This product calms my skin"
Measured: Six hours after treatment
Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin
Questions were answered six hours after treatment by the participant. The question is "I'm less distracted by my itchy skin"
Measured: Six hours after treatment
Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin
Questions were answered six hours after treatment by the participant. The question is "I feel comfortable showing my skin"
Measured: Six hours after treatment
Participant Questionnaire 6 Hours After Treatment - Shield for Skin
Questions were answered six hours after treatment by the participant. The question is "This product feels like a shield for my skin"
Measured: Six hours after treatment
Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized
Questions were answered six hours after treatment by the participant. The question is "This product leaves my skin feeling moisturized"
Measured: Six hours after treatment
Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable
Questions were answered six hours after treatment by the participant. The question is "This product makes my skin feel touchable"
Measured: Six hours after treatment
Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft
Questions were answered six hours after treatment by the participant. The question is "This product makes my skin feel soft"
Measured: Six hours after treatment
Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth
Questions were answered six hours after treatment by the participant. The question is "This product leaves my skin feeling smooth"
Measured: Six hours after treatment
Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin
Questions were answered six hours after treatment by the participant. The question is "Thinking about your experience after using this product, please describe your degree of being distracted by your itchy, eczema skin. Would you say you were"
Measured: Six hours after treatment
Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin
Questions were answered six hours after treatment by the participant. The question is "Thinking about how comfortable you felt showing your skin after using this product, would you say that you were"
Measured: Six hours after treatment
Participant Questionnaire 7 Days After Treatment - Skin Feels Calm
Questions were answered seven days after treatment by the participant. The question is "This product calms my skin"
Measured: Seven days after treatment
Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin
Questions were answered seven days after treatment by the participant. The question is "I'm less distracted by my itchy skin"
Measured: Seven days after treatment
Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking
Questions were answered seven days after treatment by the participant. The question is "I wake up to calmer skin"
Measured: Seven days after treatment
Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin
Questions were answered seven days after treatment by the participant. The question is "I feel comfortable showing my skin"
Measured: Seven days after treatment
Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture
Questions were answered seven days after treatment by the participant. The question is "This product provides long lasting moisture to my skin"
Measured: Seven days after treatment
Participant Questionnaire 7 Days After Treatment - Shield for Skin
Questions were answered seven days after treatment by the participant. The question is "This product feels like a shield for my skin"
Measured: Seven days after treatment
Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized
Questions were answered seven days after treatment by the participant. The question is "This product leaves my skin feeling moisturized"
Measured: Seven days after treatment
Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable
Questions were answered seven days after treatment by the participant. The question is "This product makes my skin feel touchable"
Measured: Seven days after treatment
Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets
Questions were answered seven days after treatment by the participant. The question is "This product does not rub off on sheets"
Measured: Seven days after treatment
Participant Questionnaire 7 Days After Treatment - Skin Feels Soft
Questions were answered seven days after treatment by the participant. The question is "This product makes my skin feel soft"
Measured: Seven days after treatment
Participant Questionnaire 7 Days After Treatment - Moisturized All Day
Questions were answered seven days after treatment by the participant. The question is "This product leaves my skin feeling moisturized all day"
Measured: Seven days after treatment
Participant Questionnaire 7 Days After Treatment - Slept Better
Questions were answered seven days after treatment by the participant. The question is "I slept better due to less itching or skin discomfort"
Measured: Seven days after treatment
Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth
Questions were answered seven days after treatment by the participant. The question is "This product leaves my skin feeling smooth"
Measured: Seven days after treatment
Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin
Questions were answered seven days after treatment by the participant. The question is "Thinking about your experience while using this product, please describe your degree of being distracted by your itchy, eczema skin. Would you say you were"
Measured: Seven days after treatment
Participant Questionnaire 7 Days After Treatment - Skin on Waking
Questions were answered seven days after treatment by the participant. The question is "Thinking about your experience when using this product, how would you describe your skin upon awakening?"
Measured: Seven days after treatment
Participant Questionnaire 7 Days After Treatment - Degree of Sleep
Questions were answered seven days after treatment by the participant. The question is "Thinking about how well you slept when using this product, would you say your sleep was?"
Measured: 7 days after treatment
Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin
Questions were answered seven days after treatment by the participant. The question is "Thinking about how comfortable you felt showing your skin while using this product, would you say that you were"
Measured: Seven days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amisha Parikh-Das, PhD, Study director, Johnson & Johnson Consumer Inc. (J&JCI)Lily Jiang, PhD, Principal investigator, Stephens & Associates, Inc (Texas Research Center)Kun M Qian, MD, Principal investigator, Stephens & Associates, Inc (Colorado Research Center)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691507
- Sponsor's protocol ID
- CO - 151102105611 - SACT
- Status last verified
- Jan 2017
- First submitted
- 22 Feb 2016
- Last updated
- 6 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Determine the Therapeutic Benefit of an Investigational Over-The-Counter Cream on Dry, Itchy Skin of Adults and Children With Atopic Dermatitis.
- ClinicalTrials.gov ID
- NCT02691507
- Acronym / sponsor ID
- CO - 151102105611 - SACT
- Conditions
- Atopic Dermatitis
- Keywords
- Eczema, Itchy Skin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 25 Feb 2016 (estimated)
- Results
- Posted 6 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this 1 week trial is to evaluate the efficacy of an over-the-counter (OTC) 1% colloidal oatmeal skin protectant cream in adults and children with mild to moderate AD.
Detailed description
Approximately 60 subjects will be enrolled to ensure 52 subjects complete the study (39 subjects: active treatment and 13 subjects: positive control).
Adults and children (ages 12 and over) will receive either a marketed or not yet marketed investigational product for the treatment of eczema. Subjects will be asked to stop use of prescription and all eczema treatments 2 days before the start of the study and during the study. Subjects will apply study product as indicated for 7 days to affected areas.
Subjects will record treatment use in a daily diary and complete questionnaires. A dermatologist will examine and score the eczema and symptoms. Skin moisture levels will also be tested.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Control | Active comparator | Device: EpiCeram Skin Barrier EmulsionMarketed - EpiCeram(R) Skin Barrier Emulsion: Apply in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin. |
| Experimental | Experimental | Drug: Experimental Product 1% Colloidal Oatmeal BalmNot Yet Marketed - 1% Colloidal Oatmeal Balm: Apply at least once per night or more if needed. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates)
- Male or female of any race or ethnicity, ages 12 and older
- Diagnosed as having eczema
- Willing to stop use of all non-assigned moisturizers and/or creams for the entire duration of the study
Key exclusion criteria (10 listed)
- Known sensitivity to any investigational product ingredient
- Females who are pregnant , breastfeeding , or planning on becoming pregnant during the study
- Individuals with a history of skin cancer
- Use of a therapeutic (over-the-counter or prescription) body wash that contains an active ingredient for eczema
- Participation in any clinical study within 30 days of Visit 1
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 |
|---|---|---|
| EpiCeram Skin Barrier EmulsionEpiCeram Skin Barrier Emulsion | Device | Positive Control |
| Experimental Product 1% Colloidal Oatmeal BalmAlso: Eczema Moisturizing BalmExperimental Product 1% Colloidal Oatmeal Balm | Drug | Experimental |
Primary outcome
Change From Baseline in the Itch Assessment Score Immediately Following Treatment
Time frame: Baseline to immediately following treatment
The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.
Change From Baseline in the Itch Assessment Score 1 Hour After Treatment
Time frame: Baseline to one hour after treatment
The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.
Change From Baseline in the Itch Assessment Score 2 Hours After Treatment
Time frame: Baseline to two hours after treatment
The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.
Change From Baseline in the Itch Assessment Score 3 Hours After Treatment
Time frame: Baseline to three hours after treatment
The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.
Change From Baseline in the Itch Assessment Score 4 Hours After Treatment
Time frame: Baseline to four hours after treatment
The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.
Change From Baseline in the Itch Assessment Score 5 Hours After Treatment
Time frame: Baseline to five hours after treatment
The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.
Change From Baseline in the Itch Assessment Score 6 Hours After Treatment
Time frame: Baseline to six hours after treatment
The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.
Change From Baseline in the Itch Assessment Score 7 Days After Treatment
Time frame: Baseline to seven days after treatment
The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.
55 secondary outcomes
Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment
Time frame: Baseline to Immediately following treatment
Change From Baseline in Mean Corneometer Measurement 1 Hour After Treatment
Time frame: Baseline to one hour after treatment
Change From Baseline in Mean Corneometer Measurement 2 Hours After Treatment
Time frame: Baseline to two hours after treatment
Change From Baseline in Mean Corneometer Measurement 3 Hours After Treatment
Time frame: Baseline to three hours after treatment
Change From Baseline in Mean Corneometer Measurement 4 Hours After Treatment
Time frame: Baseline to four hours after treatment
Change From Baseline in Mean Corneometer Measurement 5 Hours After Treatment
Time frame: Baseline to five hours after treatment
Change From Baseline in Mean Corneometer Measurement 6 Hours After Treatment
Time frame: Baseline to six hours after treatment
Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment
Time frame: Baseline to seven days after treatment
Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin
Time frame: 0 Days - Pre-treatment
Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin
Time frame: 0 Days - Pre-treatment
Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin
Time frame: 0 Days - Pre-treatment
Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin
Time frame: 0 Days - Pre-treatment
Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin
Time frame: 0 Days - Pre-treatment
Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin
Time frame: 0 Days - Pre-treatment
Participant Questionnaire on Day 0 Pre-treatment - Soft Skin
Time frame: 0 Days - Pre-treatment
Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Eczema Skin Over Past 2 Days
Time frame: 0 Days - Pre-treatment
Participant Questionnaire on Day 0 Pre-treatment - Skin Upon Waking Over Past 2 Days
Time frame: 0 Days - Pre-treatment
Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days
Time frame: 0 Days - Pre-treatment
Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days
Time frame: 0 Days - Pre-treatment
Participant Questionnaire Immediately After Treatment - Product Fast Absorbing
Time frame: 0 Days - Immediately after treatment
Participant Questionnaire Immediately After Treatment - Calm Skin
Time frame: 0 Days - Immediately after treatment
Participant Questionnaire Immediately After Treatment - Moisturized Skin
Time frame: 0 Days - Immediately after treatment
Participant Questionnaire Immediately After Treatment - Product Does Not Sting
Time frame: 0 Days - Immediately after treatment
Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture
Time frame: Four hours after treatment
Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft
Time frame: Four hours after treatment
Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture
Time frame: Five hours after treatment
Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft
Time frame: Five hours after treatment
Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture
Time frame: Six hours after treatment
Participant Questionnaire 6 Hours After Treatment - Calms Skin
Time frame: Six hours after treatment
Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin
Time frame: Six hours after treatment
Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin
Time frame: Six hours after treatment
Participant Questionnaire 6 Hours After Treatment - Shield for Skin
Time frame: Six hours after treatment
Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized
Time frame: Six hours after treatment
Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable
Time frame: Six hours after treatment
Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft
Time frame: Six hours after treatment
Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth
Time frame: Six hours after treatment
Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin
Time frame: Six hours after treatment
Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin
Time frame: Six hours after treatment
Participant Questionnaire 7 Days After Treatment - Skin Feels Calm
Time frame: Seven days after treatment
Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin
Time frame: Seven days after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Amisha Parikh-Das, PhD study director
Johnson & Johnson Consumer Inc. (J&JCI)
Lily Jiang, PhD principal investigator
Stephens & Associates, Inc (Texas Research Center)
Kun M Qian, MD principal investigator
Stephens & Associates, Inc (Colorado Research Center)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EpiCeram Skin Barrier Emulsion and Experimental Product 1% Colloidal Oatmeal Balm in people with Atopic Dermatitis, run by Johnson & Johnson Consumer Inc. (J&JCI) at 2 sites 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 4 inclusion and 10 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 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in the Itch Assessment Score Immediately Following Treatment (time frame: Baseline to immediately following treatment). The study lists 8 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 6 Mar 2017.