CompletedNCT05226143Updated Nov 14, 2022

A Study of an Eczema Spot Treatment in Providing Eczema Symptoms Relief and Lasting Itch Relief to Affected Skin Area

An interventional study of Gel Cream in Dermatitis, Atopic, sponsored by Johnson & Johnson Consumer Inc. (J&JCI). Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-11-14.

Sponsored by Johnson & Johnson Consumer Inc. (J&JCI) (formerly part of Johnson & Johnson) · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 37
Allocation: Not applicable
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Conditions studied

Dermatitis, Atopic

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Keywords

Itching
Pruritus
Dryness
Excoriation
Xerosis
Eczema
Atopic Dermatitis

In context

Dermatitis, Atopic

1,443 studies on the registry are indexed under Dermatitis, Atopic; 253 are open to participants now.

This study's enrollment of 37 is below the median of 83 across 1,143 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Johnson & Johnson Consumer Inc. (J&JCI) is the lead sponsor of 55 studies on the registry; none are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 8 (67%) have results posted.

First submitted before Johnson & Johnson Consumer Inc. (J&JCI) left Johnson & Johnson.

Browse Johnson & Johnson Consumer Inc. (J&JCI) studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 37 participants (actual)

Study arms

Experimental
Gel Cream
Participants will be provided with the Gel Cream to apply on clean, dry face (facial skin) once per day and on the target lesion on the face or body at least 2 times per day or more as needed, in the morning and at night for 14 days.
Other: Gel Cream

Interventions

OtherGel Cream
Gel Cream
Also known as: Participants will apply gel cream on facial skin and target lesions for up to 14 days.

What researchers measure

Primary outcomes

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.
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

Study locations

1 site

Dermatology Consulting Services, PLLC
High Point, North Carolina 27262, United States

References and documents

Publications

Rajka G, Langeland T. Grading of the severity of atopic dermatitis. Acta Derm Venereol Suppl (Stockh). 1989;144:13-4. doi: 10.2340/000155551441314. PubMed 2800895 ↗

Individual participant data

Plan to share: Yes — Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Data sharing details ↗ · yoda.yale.edu

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05226143
Lead sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
Responsible party: Sponsor
First posted: Feb 7, 2022
Start date: Feb 21, 2022
Primary completion: Mar 9, 2022
Completion: Mar 9, 2022
Last update: Nov 14, 2022

Study contacts

Zoe Diana Draelos, M.D.

principal investigator · Dermatology Consulting Services, High Point NC

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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