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Completed

NCT Number: NCT02691507

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

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin Manifestations Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stephens & Associates (Colorado Research Center), Colorado Springs, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

EpiCeram Skin Barrier Emulsion

Device

EpiCeram Skin Barrier Emulsion

Experimental Product 1% Colloidal Oatmeal Balm

Drug

Experimental Product 1% Colloidal Oatmeal Balm

Other names: Eczema Moisturizing Balm

Primary outcomes

  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 outcomes

  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"

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Consumer Inc. (J&JCI)

Industry

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 25, 2016
Registry last updated
Mar 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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