The purpose of this study is to evaluate the efficacy (assessed by clinical evaluation of eczema/atopic lesion severity \[atopic dermatitis severity index {ADSI} scoring\] and perceived benefits in itch \[visual analog score {VAS} scoring\]) and tolerability (assessed by clinical grading) of an investigational spot treatment Gel Cream when used on a target site of participants with mild to moderate atopic dermatitis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Gel Cream
Dermatology Consulting Services, PLLC
High Point, North Carolina, United States
Rajka and Langeland Severity Index Score of Target Lesion
Rajka and langeland severity index score of target lesion will be reported. The score is based on the grading of: (i) eczema extent based on percent (%) body area affected, (ii) eczema course based on the number of months with remission during the previous year, and (iii) eczema intensity expressed in terms of nocturnal sleep disturbance due to itch. Each parameter is scored on a scale of 1-3, and the scores are summed. The Rajka and Langeland severity score ranges from 3 to 9 (3-4=mild, 4.5-7.5=moderate, and 8-9=severe).
Time frame: At Screening
Atopic Dermatitis Severity Index (ADSI) Score of Target Lesion
ADSI score of target lesion will be reported. ADSI is a scoring system that reflects the severity of a target eczema lesion. The ADSI score is a sum of scores for 5 different parameters - erythema, pruritus, exudation, excoriation, lichenification- which are each measured on a scale of 0 (none) to 3 (severe). The total score can range from 0 (no eczema signs) to 15 (severe eczema lesion).
Time frame: Up to 14 days
Dryness of Target Lesion
Dryness of target lesion will be reported. It will be evaluated on a scale of 0 to 3 with 0=none (no dryness), 1=mild (slight, but definite dryness), 2=moderate (definite dryness), and 3=severe (marked dryness), with higher scores indicating a worse outcome.
Time frame: Up to 14 days
Tactile Roughness of Target Lesion
Tactile roughness of target lesion will be reported. It will be evaluated on a scale of 0 to 3 with 0=none (skin perfectly smooth), 1=mild (mild roughness), 2=moderate (moderate roughness), and 3=severe (severe roughness), with higher scores indicating a worse outcome.
Time frame: Up to 14 days
Erythema of Target Lesion
Erythema of target lesion (derived from ADSI sub-score) will be reported. It will be evaluated on a scale of 0 to 3 with 0=none (no redness), 1=mild (mildly detectable erythema; pink), 2=moderate (dull red; clearly distinguishable), and 3=severe (deep, dark red; marked and extensive), with higher scores indicating a worse outcome.
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Time frame: Up to 14 days
Pruritus of Target Lesion
Pruritus of target lesion (derived from ADSI sub-score) will be reported. It will be evaluated on a scale of 0 to 3 with 0=none (no itching), 1=mild (occasional, slight itching), 2=moderate (frequent or intermittent itching; does not disturb sleep), and 3=severe (constant, bothersome itching that disturbs sleep or normal activity), with higher scores indicating a worse outcome.
Time frame: Up to 14 days
Skin Tone of Lesion Compared to Normal Overall Skin Tone
Skin tone of lesion compared to normal overall skin tone will be reported. It will be evaluated on a scale of 0 to 9 with 0=none (same overall tone \[color\] of normal, non-involved lesional skin), 1-3=mild (slightly different color/skin tone compared to normal, non-involved lesional skin), 4-6=moderate (moderately different color/skin tone compared to normal, non-involved lesional skin), and 7-9=severe (marked, severe difference in color/skin tone \[either hypo/hyper pigmented, red\] compared to normal, non-involved lesional skin), with higher scores indicating a worse outcome.
Time frame: Up to 14 days
Overall Irritation of Facial Skin
Overall irritation of the facial skin will be reported. It will be evaluated on a scale of 0 to 4 with 0=none (no Reaction), 1=mild (definite pink to red coloration), 2=moderate (increased redness, possible edema), 3=severe (very red, with edema and vesiculation), 4=very severe (deep red, swelling and edema with signs of bullae formation and necrosis), with higher scores indicating a worse outcome.
Time frame: Up to 14 days
Itch Assessment of Target Lesion
Itch assessment of target lesion will be evaluated by using visual analog scale (VAS). Participants will be asked to rate his/her itch severity of the target lesion using VAS as score ranges from 0 (no itch) to 10 (worst itch possible).
Time frame: Up to 14 days
Soothing Assessments of Target Lesion
Soothing assessment based on participants self-assessment questionnaire score will be reported. Participants will be asked to complete the following question: 1) the product soothed/calmed the eczema test site area; 2) the eczema test site area feels soothed/calmed. Participant responses for each question will have 5 response options such as: Strongly agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree.
Time frame: Up to 14 days
Cooling Assessment of Target Lesion
Cooling assessment of target lesion based on participants self-assessment questionnaire score will be reported. Participants will be asked to complete the following question: "The product provided a cooling sensation to the test site area". Participant responses for the question will have 5 response options such as: Strongly agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree.
Time frame: Baseline (Day 0)
Burning/Stinging Sensation of the Facial Skin
Burning/Stinging sensation of the facial skin will be reported. It will be evaluated on a scale of 0 to 3 with 0=none (no burning/stinging of the treatment area), 1=mild (slight burning/stinging sensation of the treatment area; slightly bothersome), 2=moderate (definite burning/stinging of the treatment area that is somewhat bothersome), and 3=severe (intense burning/stinging sensation of the treatment area that causes definite discomfort and may interrupt daily activities and/or sleep), with higher scores indicating a worse outcome.
Time frame: Up to 14 days
Skin pH Measurements of Target Lesion
Skin pH measurement of target lesion will be reported. It will be measured using a DermaLab pH probe attached to a Cortex Technologies computer platform.
Time frame: Up to 14 days
Skin Hydration of Target Lesion as Measured by Corneometer
Skin hydration of target lesion as measured by Corneometer will be reported. Corneometer measurements will be taken using a DermaLab pin probe attached to a Cortex Technologies computer platform.
Time frame: Up to 14 days
Transepidermal Water Loss (TEWL) Measurement of Target Lesion
TEWL measurement of target lesion will be assessed. TEWL measurements will be taken using a RG-1 Evaporimeter (cyberDERM) equipped with DermaLab (Cortex Technologies) probes in conjunction with a computer.
Time frame: Up to 14 days
Digital Photograph of Target Lesion
Digital photograph of target tension will be reported. The images of each participant's target lesion will be captured using a Canfield D90 digital Slue camera using visible light. This will allow fixed to stop reproducible images to be obtained. A close-up image will be taken of each target lesion with an appropriately draped background.
Time frame: Up to 14 days
Microbiome Sampling of Target Lesion
The surface skin microbiome will be collected from target lesion. A swabbing technique will be used to collect surface skin microflora for analysis to determine the effect of the gel cream on the skin microflora.
Time frame: Up to 14 days
Itch Quality of Life (ItchQOL) Questionnaire
ItchQOl is a 54-item questionnaire assessing the pruritus-specific disease burden on 2 domains: frequency and bother. The responses to the frequency items are scored on a 1 (never) to 5 (all the time) scale and the responses to the bother items are scored on a 1 (not bothered) to 5 (severely bothered) scale. Higher scores indicate a more adverse impact on quality of life.
Time frame: Up to 14 days
Dermatology Life Quality Index (DLQI) Score
The DLQI is a validated questionnaire used to measure the impact of atopic dermatitis (AD) disease symptoms and treatment on health-related quality of life. DLQI consisting of a set of 10 questions which assess quality of life over the past week. Responses to each questions were assessed on a scale of 0 to 3, where 0 is "not at all or not relevant" and 3 is "very much". Scores from all 10 questions added up to give total DLQI scores ranged from 0 (no effect at all on participant's life) to 30 (extremely large effect on participant's life), higher scores indicated more impact on quality of life.
Time frame: Up to 14 days
Final Assessment Questionnaire
Final assessment questionnaire will be completed by the participant to provide subjective assessment of the gel cream. Participant responses for each question will have 5 response options such as: Strongly agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree.
Time frame: At Day 14