A Study of an Eczema Spot Treatment in Providing Eczema Symptoms Relief and Lasting Itch Relief t… (NCT05226143) | Clinical Trial Compass
CompletedNot Applicable
A Study of an Eczema Spot Treatment in Providing Eczema Symptoms Relief and Lasting Itch Relief to Affected Skin Area
United States37 participantsStarted 2022-02-21
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Fitzpatrick Skin Type I, II, III, IV, V, or VI
* Self-reported natural skin tone Pale/fair to light white, White to light beige, Beige to light tan/light olive, Medium tan/medium olive to light brown, Medium brown to dark brown, or Darkest brown to darkest black targeting the following: a) Skin tones "Pale/fair to light white" and "White to light beige" (at least number of participants (n)= 4); b) Skin tones "Beige to light tan/light olive" and "Medium tan/medium olive to light brown" (at least n = 4); c) Skin tones "Medium brown to dark brown" and "Darkest brown to darkest black" (at least n = 4)
* Men who are regular shavers (at least 3 times per week) and do not have beards. A mustache and/or small goatee is allowed as long as the majority of the face and neck are shaved
* Has mild to moderate eczema severity rating at Visit 1, defined as a score of 3 - 7.5 on the Rajka and Langeland Severity Index
* Has at least 1 lesion area; either on face or body at Visit 1 with a score of 5 - 12 on the Atopic Dermatitis Severity Index (ADSI) score, ADSI pruritus sub-score of 1 - 2 (mild - moderate), and ADSI erythema sub-score of at least 2 (moderate) to be followed for the duration of the study
* Has a Visual Analog Score (VAS) score greater than or equal to (\>=) 4 for itch on the target lesion
* Has experienced a recent (within the past 1 year) itch flare up and is currently experiencing preflare up symptoms at Visit 1
* Is a regular user of body moisturizers…
What they're measuring
1
Rajka and Langeland Severity Index Score of Target Lesion
Timeframe: At Screening
2
Atopic Dermatitis Severity Index (ADSI) Score of Target Lesion
Timeframe: Up to 14 days
3
Dryness of Target Lesion
Timeframe: Up to 14 days
4
Tactile Roughness of Target Lesion
Timeframe: Up to 14 days
5
Erythema of Target Lesion
Timeframe: Up to 14 days
6
Pruritus of Target Lesion
Timeframe: Up to 14 days
7
Skin Tone of Lesion Compared to Normal Overall Skin Tone