Clinical trial NCT05226143: A Study of an Eczema Spot Treatment in Providing Eczema Symptoms Relief and Lasting Itch Relief to Affected Skin Area
Official title: A Single Center, Clinical Study to Determine the Safety and Efficacy of an Eczema Spot Treatment in Providing Eczema Symptoms Relief and Lasting Itch Relief to Affected Skin Area
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatitis, Atopic
Keywords: Itching
Pruritus
Dryness
Excoriation
Xerosis
Eczema
Atopic Dermatitis
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2022-02-07
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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, defined as 2 -3 times per week
* Has not had any facial treatments in the past 6 months and is willing to withhold all facial treatments during the course of the study including facials, facial peels, photo facials, laser treatments, dermabrasion, botulinum toxin (Botox), injectable filler treatments, intense pulsed light (IPL), acid treatments, tightening treatments, facial plastic surgery, or any other treatment administered by a physician or skin care professional designed to improve the appearance or firmness of facial skin
* Generally in good health based on medical history reported by the participant
* Able to read, write, speak, and understand English
* Individual has signed the Consent for Photograph Release and informed consent document (ICD) including Health Insurance Portability and Accountability Act (HIPAA) disclosure
* Intends to complete the study and is willing and able to follow all study instructions

Exclusion Criteria:

* Has known allergies or adverse reactions to common topical skincare products or ingredients in the investigational study material (ISM)
* Presents with a health condition and/or pre-existing acute or chronic dermatologic conditions (example, psoriasis, rosacea, rashes, many and/or severe excoriations, Et cetera \[etc.\]) that could interfere with the outcome of the study or be deemed inappropriate for study participation as determined by the principal investigator (PI)
* Has severe eczema severity rating at Visit 1, defined as a score of 8 - 9 on the Rajka and Langeland Severity Index
* Has a bacterial, fungal, or viral skin infection or is susceptible to cutaneous infections
* Is currently using an over-the-counter (OTC) moisturizer specifically indicated for eczema (Active Ingredient: 1 percent \[%\] - 2% Colloidal Oatmeal stated in the Drug Facts Box) within 3 days prior to Visit 1
* Is currently using Class I-III topical corticosteroids or systemic medications that will affect or have an indirect effect on his/her eczema (including but not limited to betamethasone, clobetasol, desoximetasone, diflorasone, fluocinonide, fluticasone, halcinonide, halobetasol, and mometasone) or have used the aforementioned medications within 4 weeks before study enrollment. (participants on a stabilized regimen of antihistamines for allergy are permitted into the study)
* Has a history of immunosuppression/immune deficiency disorders (including human immunodeficiency virus \[HIV\] infection or acquired immunodeficiency syndrome \[AIDS\]) or currently using immunosuppressive medications (example, azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.), and/or radiotherapy
* Has used an over-the-counter (OTC) hydrocortisone/steroid and/or prescribed topical medications within 2 weeks prior to Visit 1
* Has used an OTC anti-itch spot treatment within 1 week prior to Visit 1
* Has applied moisturizers on the face and/or body within 3 days prior to Visit 1
* Has a history of a confirmed or suspected COVID-19 infection within 30 days prior to the study visit.
* Within 14 days prior to Visit 1, has been in close contact (exposure within 6 feet for a cumulative time of 15 minutes or more over a 24-hour period) with anyone who has been infected with COVID-19
* Is under a COVID-19 isolation/quarantine order
* Has experienced any of the following self-reported symptoms of COVID-19 within 2 weeks prior to the study visit: a) Unexplained cough, shortness of breath/difficulty breathing, fatigue, body aches (headaches, muscle pain, stomachaches), conjunctivitis, loss of smell, loss of taste, poor appetite, nausea, vomiting, diarrhea, palpitations, or chest pain/tightness; b) Temperature greater than or equal to (\>=) 37.2 degree Celsius (°C) / 99 degree Fahrenheit (°F), measured; c) Use of fever or pain reducers within 2 days prior to the study visit
* Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication
* Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including: a) Prescription medication (oral or topical) that can make skin more sensitive or have an effect on the skin (that is, antibiotics, hormones, insulin, etc.) within 6 weeks before Visit 1; b) Immunosuppressive or steroidal drugs within 2 months before Visit 1; c) Non-steroidal anti-inflammatory drugs within 5 days before Visit 1; d) Antihistamines within 2 weeks before Visit 1
* Is self-reported to be breastfeeding, pregnant or planning to become pregnant during the study
* Has a history of or a concurrent health/other condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study
* Has started prescription testosterone therapy less than 3 months prior to study entry or planning on starting, stopping, or changing doses of testosterone therapy during the study (example, testosterone cypionate, testosterone enanthate, testosterone pellet, testosterone undecanoate) or on a testosterone booster or prescription testosterone (example, DHEA, Omnadren, Sustanon, testosterone cypionate, testosterone enanthate, testosterone propionate, testosterone phenylpropionate, tribulus)
* Has planned surgeries and/or invasive medical procedures during the course of the study
* Is simultaneously participating in any other clinical study or has participated in any product-use study within 30 days prior to Visit 1
* Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor

Primary outcomes:
measure: Rajka and Langeland Severity Index Score of Target Lesion
timeFrame: At Screening
measure: Atopic Dermatitis Severity Index (ADSI) Score of Target Lesion
timeFrame: Up to 14 days
measure: Dryness of Target Lesion
timeFrame: Up to 14 days
measure: Tactile Roughness of Target Lesion
timeFrame: Up to 14 days
measure: Erythema of Target Lesion
timeFrame: Up to 14 days
measure: Pruritus of Target Lesion
timeFrame: Up to 14 days
measure: Skin Tone of Lesion Compared to Normal Overall Skin Tone
timeFrame: Up to 14 days
measure: Overall Irritation of Facial Skin
timeFrame: Up to 14 days
measure: Itch Assessment of Target Lesion
timeFrame: Up to 14 days
measure: Soothing Assessments of Target Lesion
timeFrame: Up to 14 days
measure: Cooling Assessment of Target Lesion
timeFrame: Baseline (Day 0)
measure: Burning/Stinging Sensation of the Facial Skin
timeFrame: Up to 14 days
measure: Skin pH Measurements of Target Lesion
timeFrame: Up to 14 days
measure: Skin Hydration of Target Lesion as Measured by Corneometer
timeFrame: Up to 14 days
measure: Transepidermal Water Loss (TEWL) Measurement of Target Lesion
timeFrame: Up to 14 days
measure: Digital Photograph of Target Lesion
timeFrame: Up to 14 days
measure: Microbiome Sampling of Target Lesion
timeFrame: Up to 14 days
measure: Itch Quality of Life (ItchQOL) Questionnaire
timeFrame: Up to 14 days
measure: Dermatology Life Quality Index (DLQI) Score
timeFrame: Up to 14 days
measure: Final Assessment Questionnaire
timeFrame: At Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: High Point
country: United States
facility: Dermatology Consulting Services, PLLC
state: North Carolina
Study officials:
affiliation: Dermatology Consulting Services, High Point NC
name: Zoe Diana Draelos, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rajka G, Langeland T. Grading of the severity of atopic dermatitis. Acta Derm Venereol Suppl (Stockh). 1989;144:13-4. doi: 10.2340/000155551441314.