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Trial to Determine the Therapeutic Benefit of an OTC Cream on Dry, Itchy Skin of Adults and Children With Eczema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02691507
Recruitment Status : Completed
First Posted : February 25, 2016
Results First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )

Brief 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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Device: EpiCeram Skin Barrier Emulsion Drug: Experimental Product 1% Colloidal Oatmeal Balm Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : February 2016
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Itching

Arm Intervention/treatment
Active Comparator: Positive Control
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.
Device: EpiCeram Skin Barrier Emulsion
EpiCeram Skin Barrier Emulsion

Experimental: Experimental
Not Yet Marketed - 1% Colloidal Oatmeal Balm: Apply at least once per night or more if needed.
Drug: Experimental Product 1% Colloidal Oatmeal Balm
Experimental Product 1% Colloidal Oatmeal Balm
Other Name: Eczema Moisturizing Balm




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Secondary Outcome Measures :
  1. Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment [ Time Frame: Baseline to 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.

  2. Change From Baseline in Mean Corneometer Measurement 1 Hour After Treatment [ Time Frame: Baseline to one 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.

  3. Change From Baseline in Mean Corneometer Measurement 2 Hours After Treatment [ Time Frame: Baseline to two 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.

  4. Change From Baseline in Mean Corneometer Measurement 3 Hours After Treatment [ Time Frame: Baseline to three 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.

  5. Change From Baseline in Mean Corneometer Measurement 4 Hours After Treatment [ Time Frame: Baseline to four 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.

  6. Change From Baseline in Mean Corneometer Measurement 5 Hours After Treatment [ Time Frame: Baseline to five 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.

  7. Change From Baseline in Mean Corneometer Measurement 6 Hours After Treatment [ Time Frame: Baseline to six 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.

  8. Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment [ Time Frame: Baseline to seven 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.

  9. Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin [ Time Frame: 0 Days - Pre-treatment ]
    Questions were answered before treatment by the participant. The question is "I'm less distracted by my itchy skin"

  10. Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin [ Time Frame: 0 Days - Pre-treatment ]
    Questions were answered before treatment by the participant. The question is "I wake up to calmer skin"

  11. Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin [ Time Frame: 0 Days - Pre-treatment ]
    Questions were answered before treatment by the participant. The question is "My skin feels smooth"

  12. Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin [ Time Frame: 0 Days - Pre-treatment ]
    Questions were answered before treatment by the participant. The question is "I feel comfortable showing my skin"

  13. Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin [ Time Frame: 0 Days - Pre-treatment ]
    Questions were answered before treatment by the participant. The question is "My skin feels moisturized"

  14. Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin [ Time Frame: 0 Days - Pre-treatment ]
    Questions were answered before treatment by the participant. The question is "My skin feels touchable"

  15. Participant Questionnaire on Day 0 Pre-treatment - Soft Skin [ Time Frame: 0 Days - Pre-treatment ]
    Questions were answered before treatment by the participant. The question is "My skin feels soft"

  16. Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Eczema Skin Over Past 2 Days [ Time Frame: 0 Days - Pre-treatment ]
    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"

  17. Participant Questionnaire on Day 0 Pre-treatment - Skin Upon Waking Over Past 2 Days [ Time Frame: 0 Days - Pre-treatment ]
    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?"

  18. Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days [ Time Frame: 0 Days - Pre-treatment ]
    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?"

  19. Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days [ Time Frame: 0 Days - Pre-treatment ]
    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"

  20. Participant Questionnaire Immediately After Treatment - Product Fast Absorbing [ Time Frame: 0 Days - Immediately after treatment ]
    Questions were answered immediately after treatment by the participant. The question is "This product is fast absorbing"

  21. Participant Questionnaire Immediately After Treatment - Calm Skin [ Time Frame: 0 Days - Immediately after treatment ]
    Questions were answered immediately after treatment by the participant. The question is "This product calms my skin"

  22. Participant Questionnaire Immediately After Treatment - Moisturized Skin [ Time Frame: 0 Days - Immediately after treatment ]
    Questions were answered immediately after treatment by the participant. The question is "This product leaves my skin feeling immediately moisturized"

  23. Participant Questionnaire Immediately After Treatment - Product Does Not Sting [ Time Frame: 0 Days - Immediately after treatment ]
    Questions were answered immediately after treatment by the participant. The question is "This product does not sting when applied"

  24. Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture [ Time Frame: Four hours after treatment ]
    Questions were answered four hours after treatment by the participant. The question is "This product provides long lasting moisture"

  25. Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft [ Time Frame: Four hours after treatment ]
    Questions were answered four hours after treatment by the participant. The question is "This product leaves my skin feeling soft"

  26. Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture [ Time Frame: Five hours after treatment ]
    Questions were answered five hours after treatment by the participant. The question is "This product provides long lasting moisture"

  27. Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft [ Time Frame: Five hours after treatment ]
    Questions were answered five hours after treatment by the participant. The question is "This product leaves my skin feeling soft"

  28. Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture [ Time Frame: Six hours after treatment ]
    Questions were answered six hours after treatment by the participant. The question is "This product provides long lasting moisture"

  29. Participant Questionnaire 6 Hours After Treatment - Calms Skin [ Time Frame: Six hours after treatment ]
    Questions were answered six hours after treatment by the participant. The question is "This product calms my skin"

  30. Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin [ Time Frame: Six hours after treatment ]
    Questions were answered six hours after treatment by the participant. The question is "I'm less distracted by my itchy skin"

  31. Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin [ Time Frame: Six hours after treatment ]
    Questions were answered six hours after treatment by the participant. The question is "I feel comfortable showing my skin"

  32. Participant Questionnaire 6 Hours After Treatment - Shield for Skin [ Time Frame: Six hours after treatment ]
    Questions were answered six hours after treatment by the participant. The question is "This product feels like a shield for my skin"

  33. Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized [ Time Frame: Six hours after treatment ]
    Questions were answered six hours after treatment by the participant. The question is "This product leaves my skin feeling moisturized"

  34. Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable [ Time Frame: Six hours after treatment ]
    Questions were answered six hours after treatment by the participant. The question is "This product makes my skin feel touchable"

  35. Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft [ Time Frame: Six hours after treatment ]
    Questions were answered six hours after treatment by the participant. The question is "This product makes my skin feel soft"

  36. Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth [ Time Frame: Six hours after treatment ]
    Questions were answered six hours after treatment by the participant. The question is "This product leaves my skin feeling smooth"

  37. Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin [ Time Frame: Six hours after treatment ]
    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"

  38. Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin [ Time Frame: Six hours after treatment ]
    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"

  39. Participant Questionnaire 7 Days After Treatment - Skin Feels Calm [ Time Frame: Seven days after treatment ]
    Questions were answered seven days after treatment by the participant. The question is "This product calms my skin"

  40. Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin [ Time Frame: Seven days after treatment ]
    Questions were answered seven days after treatment by the participant. The question is "I'm less distracted by my itchy skin"

  41. Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking [ Time Frame: Seven days after treatment ]
    Questions were answered seven days after treatment by the participant. The question is "I wake up to calmer skin"

  42. Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin [ Time Frame: Seven days after treatment ]
    Questions were answered seven days after treatment by the participant. The question is "I feel comfortable showing my skin"

  43. Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture [ Time Frame: Seven days after treatment ]
    Questions were answered seven days after treatment by the participant. The question is "This product provides long lasting moisture to my skin"

  44. Participant Questionnaire 7 Days After Treatment - Shield for Skin [ Time Frame: Seven days after treatment ]
    Questions were answered seven days after treatment by the participant. The question is "This product feels like a shield for my skin"

  45. Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized [ Time Frame: Seven days after treatment ]
    Questions were answered seven days after treatment by the participant. The question is "This product leaves my skin feeling moisturized"

  46. Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable [ Time Frame: Seven days after treatment ]
    Questions were answered seven days after treatment by the participant. The question is "This product makes my skin feel touchable"

  47. Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets [ Time Frame: Seven days after treatment ]
    Questions were answered seven days after treatment by the participant. The question is "This product does not rub off on sheets"

  48. Participant Questionnaire 7 Days After Treatment - Skin Feels Soft [ Time Frame: Seven days after treatment ]
    Questions were answered seven days after treatment by the participant. The question is "This product makes my skin feel soft"

  49. Participant Questionnaire 7 Days After Treatment - Moisturized All Day [ Time Frame: Seven days after treatment ]
    Questions were answered seven days after treatment by the participant. The question is "This product leaves my skin feeling moisturized all day"

  50. Participant Questionnaire 7 Days After Treatment - Slept Better [ Time Frame: Seven days after treatment ]
    Questions were answered seven days after treatment by the participant. The question is "I slept better due to less itching or skin discomfort"

  51. Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth [ Time Frame: Seven days after treatment ]
    Questions were answered seven days after treatment by the participant. The question is "This product leaves my skin feeling smooth"

  52. Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin [ Time Frame: Seven days after treatment ]
    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"

  53. Participant Questionnaire 7 Days After Treatment - Skin on Waking [ Time Frame: Seven days after treatment ]
    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?"

  54. Participant Questionnaire 7 Days After Treatment - Degree of Sleep [ Time Frame: 7 days after treatment ]
    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?"

  55. Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin [ Time Frame: Seven days after treatment ]
    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"



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates)
  2. Male or female of any race or ethnicity, ages 12 and older
  3. Diagnosed as having eczema
  4. Willing to stop use of all non-assigned moisturizers and/or creams for the entire duration of the study

Exclusion Criteria:

  1. Known sensitivity to any investigational product ingredient
  2. Females who are pregnant , breastfeeding , or planning on becoming pregnant during the study
  3. Individuals with a history of skin cancer
  4. Use of a therapeutic (over-the-counter or prescription) body wash that contains an active ingredient for eczema
  5. Participation in any clinical study within 30 days of Visit 1
  6. Active infection of any type at the start of the study
  7. Diagnosed as having severe eczema
  8. Has a compromised immune system
  9. Individuals with any planned surgeries and/or invasive medical procedures during the course of the study
  10. Requires greater than 2.0mg/day inhaled or intranasal corticosteroids

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02691507


Locations
Layout table for location information
United States, Colorado
Stephens & Associates (Colorado Research Center)
Colorado Springs, Colorado, United States, 80915
United States, Texas
Stephens & Associates (Texas Reserach Center)
Richardson, Texas, United States, 75081
Sponsors and Collaborators
Johnson & Johnson Consumer Inc. (J&JCI)
Investigators
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Study Director: Amisha Parikh-Das, PhD Johnson & Johnson Consumer Inc. (J&JCI)
Principal Investigator: Lily Jiang, PhD Stephens & Associates, Inc (Texas Research Center)
Principal Investigator: Kun M Qian, MD Stephens & Associates, Inc (Colorado Research Center)

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Responsible Party: Johnson & Johnson Consumer Inc. (J&JCI)
ClinicalTrials.gov Identifier: NCT02691507     History of Changes
Other Study ID Numbers: CO - 151102105611 - SACT
First Posted: February 25, 2016    Key Record Dates
Results First Posted: March 6, 2017
Last Update Posted: March 6, 2017
Last Verified: January 2017

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) ):
Eczema, Itchy Skin

Additional relevant MeSH terms:
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Eczema
Dermatitis
Dermatitis, Atopic
Pruritus
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Manifestations
Signs and Symptoms
Decanoic acid
Antifungal Agents
Anti-Infective Agents