Atopic Dermatitis Clinical Trial
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.
Status | Completed |
Enrollment | 52 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 12 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Stephens & Associates (Colorado Research Center) | Colorado Springs | Colorado |
United States | Stephens & Associates (Texas Reserach Center) | Richardson | Texas |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Consumer Inc. (J&JCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Itch assessment: 10 cm Visual Analog Scale (VAS) | The severity of the itch will be assessed by subject using a 10cm VAS scale. The VAS will follow the following scale: 0 indicates "No itch" and 10 indicates "Severe Itch". | Visit 1: Screening [Day -2] | No |
Primary | Itch assessment: 10 cm Visual Analog Scale (VAS) | The severity of the itch will be assessed by subject using a 10cm VAS scale. The VAS will follow the following scale: 0 indicates "No itch" and 10 indicates "Severe Itch". | Visit 2: Baseline [Day 0] Pre-Treatment and Immediately Post-Treatment | No |
Primary | Itch assessment: 10 cm Visual Analog Scale (VAS) | The severity of the itch will be assessed by subject using a 10cm VAS scale. The VAS will follow the following scale: 0 indicates "No itch" and 10 indicates "Severe Itch". | Visit 2: 1 hour post application [Day 0] | No |
Primary | Itch assessment: 10 cm Visual Analog Scale (VAS) | The severity of the itch will be assessed by subject using a 10cm VAS scale. The VAS will follow the following scale: 0 indicates "No itch" and 10 indicates "Severe Itch". | Visit 2: 2 hours post application [Day 0] | No |
Primary | Itch assessment: 10 cm Visual Analog Scale (VAS) | The severity of the itch will be assessed by subject using a 10cm VAS scale. The VAS will follow the following scale: 0 indicates "No itch" and 10 indicates "Severe Itch". | Visit 2: 3 hours post application [Day 0] | No |
Primary | Itch assessment: 10 cm Visual Analog Scale (VAS) | The severity of the itch will be assessed by subject using a 10cm VAS scale. The VAS will follow the following scale: 0 indicates "No itch" and 10 indicates "Severe Itch". | Visit 2: 4 hours post application [Day 0] | No |
Primary | Itch assessment: 10 cm Visual Analog Scale (VAS) | The severity of the itch will be assessed by subject using a 10cm VAS scale. The VAS will follow the following scale: 0 indicates "No itch" and 10 indicates "Severe Itch". | Visit 2: 5 hours post application [Day 0] | No |
Primary | Itch assessment: 10 cm Visual Analog Scale (VAS) | The severity of the itch will be assessed by subject using a 10cm VAS scale. The VAS will follow the following scale: 0 indicates "No itch" and 10 indicates "Severe Itch". | Visit 2: 6 hours post application [Day 0] | No |
Primary | Itch assessment: 10 cm Visual Analog Scale (VAS) | The severity of the itch will be assessed by subject using a 10cm VAS scale. The VAS will follow the following scale: 0 indicates "No itch" and 10 indicates "Severe Itch". | Visit 3: Day 7 | No |
Secondary | Corneometer measurements | Corneometer will be used to measure moisture content on the skin surface. The measurement has no units but is proportional to the dielectric constant of the surface layers of the skin and increases as the skin becomes hydrated. Measurements will be taken before and after product treatment. | Visit 2: Baseline [Day 0] Pre-Treatment and Immediately Post-Treatment | No |
Secondary | Corneometer measurements | Corneometer will be used to measure moisture content on the skin surface. The measurement has no units but is proportional to the dielectric constant of the surface layers of the skin and increases as the skin becomes hydrated. Measurements will be taken after product treatment. | Visit 2: 1 hour post application [Day 0] | No |
Secondary | Corneometer measurements | Corneometer will be used to measure moisture content on the skin surface. The measurement has no units but is proportional to the dielectric constant of the surface layers of the skin and increases as the skin becomes hydrated. Measurements will be taken after product treatment. | Visit 2: 2 hours post application [Day 0] | No |
Secondary | Corneometer measurements | Corneometer will be used to measure moisture content on the skin surface. The measurement has no units but is proportional to the dielectric constant of the surface layers of the skin and increases as the skin becomes hydrated. Measurements will be taken after product treatment. | Visit 2: 3 hours post application [Day 0] | No |
Secondary | Corneometer measurements | Corneometer will be used to measure moisture content on the skin surface. The measurement has no units but is proportional to the dielectric constant of the surface layers of the skin and increases as the skin becomes hydrated. Measurements will be taken after product treatment. | Visit 2: 4 hours post application [Day 0] | No |
Secondary | Corneometer measurements | Corneometer will be used to measure moisture content on the skin surface. The measurement has no units but is proportional to the dielectric constant of the surface layers of the skin and increases as the skin becomes hydrated. Measurements will be taken after product treatment. | Visit 2: 5 hours post application [Day 0] | No |
Secondary | Corneometer measurements | Corneometer will be used to measure moisture content on the skin surface. The measurement has no units but is proportional to the dielectric constant of the surface layers of the skin and increases as the skin becomes hydrated. Measurements will be taken after product treatment. | Visit 2: 6 hours post application [Day 0] | No |
Secondary | Corneometer measurements | Corneometer will be used to measure moisture content on the skin surface. The measurement has no units but is proportional to the dielectric constant of the surface layers of the skin and increases as the skin becomes hydrated. Measurements will be taken before and after product treatment. | Visit 3: Day 7 | No |
Secondary | Participant Questionnaire | Questions to be answered by subjects. Questions include overall look (smooth , healthy) and feel (soft , smooth) of participants' skin; and affected area's look (smooth , healthy) and feel (soft , smooth). Participants will choose from 6 answers: I Don't have an opinion , Strongly Agree , Somewhat Agree , Neither agree or disagree , Somewhat disagree , Strongly Disagree. | Visit 2: Baseline [Day 0] Pre-Treatment and Immediately Post-Treatment | No |
Secondary | Participant Questionnaire | Questions to be answered by subjects. Questions include overall look (smooth , healthy) and feel (soft , smooth) of participants' skin; and affected area's look (smooth , healthy) and feel (soft , smooth). Participants will choose from 6 answers: I Don't have an opinion , Strongly Agree , Somewhat Agree , Neither agree or disagree , Somewhat disagree , Strongly Disagree. | Visit 2: 4 hours post application [Day 0] | No |
Secondary | Participant Questionnaire | Questions to be answered by subjects. Questions include overall look (smooth , healthy) and feel (soft , smooth) of participants' skin; and affected area's look (smooth , healthy) and feel (soft , smooth). Participants will choose from 6 answers: I Don't have an opinion , Strongly Agree , Somewhat Agree , Neither agree or disagree , Somewhat disagree , Strongly Disagree. | Visit 2: 5 hours post application [Day 0] | No |
Secondary | Participant Questionnaire | Questions to be answered by subjects. Questions include overall look (smooth , healthy) and feel (soft , smooth) of participants' skin; and affected area's look (smooth , healthy) and feel (soft , smooth). Participants will choose from 6 answers: I Don't have an opinion , Strongly Agree , Somewhat Agree , Neither agree or disagree , Somewhat disagree , Strongly Disagree. | Visit 2: 6 hours post application [Day 0] | No |
Secondary | Participant Questionnaire | Questions to be answered by subjects. Questions include overall look (smooth , healthy) and feel (soft , smooth) of participants' skin; and affected area's look (smooth , healthy) and feel (soft , smooth). Participants will choose from 6 answers: I Don't have an opinion , Strongly Agree , Somewhat Agree , Neither agree or disagree , Somewhat disagree , Strongly Disagree. | Visit 3: [Day 7] | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05018806 -
Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis
|
Phase 2 | |
Completed |
NCT04090229 -
A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis
|
Phase 1 | |
Terminated |
NCT03847389 -
Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT05388760 -
Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1)
|
Phase 2 | |
Completed |
NCT05530707 -
Evaluation of Acceptability, Skin Barrier Restoration and Balance of Atopic Skin Using Moisturizer
|
N/A | |
Completed |
NCT02595073 -
Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis
|
Phase 3 | |
Recruiting |
NCT05509023 -
Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD)
|
Phase 2 | |
Recruiting |
NCT05048056 -
Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis
|
Phase 2 | |
Completed |
NCT04598269 -
Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis
|
Phase 2 | |
Recruiting |
NCT03936335 -
An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
|
||
Withdrawn |
NCT03089476 -
Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy
|
N/A | |
Recruiting |
NCT05029895 -
A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
|
||
Terminated |
NCT03654755 -
Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis
|
Phase 2 | |
Completed |
NCT04556461 -
Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function
|
Phase 2 | |
Recruiting |
NCT04818138 -
BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort
|
N/A | |
Completed |
NCT03719742 -
A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer
|
N/A | |
Completed |
NCT05375955 -
A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.
|
Phase 2 | |
Completed |
NCT03441568 -
In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control
|
N/A | |
Recruiting |
NCT06366932 -
Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models
|
Phase 4 | |
Completed |
NCT03304470 -
A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis
|
Phase 2 |