8-Week Atopic Dermatitis (AD) Treatment Study (NCT03386032)

01

Study summary

This is a study to investigate the clinical effectiveness of the Sponsor's experimental cream treatment on eczema as measured by visual grading of SCORAD (scoring of atopic dermatitis).

Read the detailed description

This will be a 9-week, randomized, double blind, parallel comparison study consisting of a 1-week washout phase followed by an 8-week treatment phase. This study will be executed by one clinical research company utilizing two test sites and up to 62 subjects with moderate or severe atopic dermatitis, ages 12-65, will be enrolled. Subjects that are enrolled will be placed on one of three products (e.g. Sponsor's Experimental Cream Treatment, a basic moisturizer, or a positive control - Desonide) and will be required to use the assigned product twice a day for the duration of the 8-week treatment phase.

02

Conditions studied

Atopic Dermatitis Eczema

Browse trials for

03

In context

Dermatitis, Atopic

1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.

This study's enrollment of 65 is below the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Procter and Gamble is the lead sponsor of 83 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.

Browse Procter and Gamble studies →

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

04

Who can participate

Ages eligible: 12 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

Is a generally healthy, male or female, 12-65 years old, inclusive;
Diagnosis of moderate or greater Atopic Dermatitis as determined by SCORAD (SCORAD >=25);
Is able to read and understand instructions in English.

Exclusion criteria

Exclusion Criteria:

Is currently participating or has participated in another interventional clinical study in the past 2 weeks;
Currently or has been diagnosed or treated for cancer in the past 5 years;
Requires any topical or systemic medications that could affect the course of their atopic dermatitis during the study period (except inhaled and/or stable antihistamines for asthma or allergies);
Has used systemic treatments that could affect AD within 30 days or 5 half- lives. (i.e. retinoids, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine and oral/injectable corticosteroids);
Has a known to any corticosteroid creams;
Has been diagnosed with any allergies to Oat or derivatives;
Has any active infections or has used antibiotics in the past 7 days;
Has any physical attributes or skin conditions that might interfere with the clear visual or instrumental assessments.(i.e. cuts, sunburn, birth marks, tattoos, extensive scarring, excessive hair growth or acne);
Has an immunologic or infectious disease (e.g. hepatitis, tuberculosis, or AIDS, lupus rheumatoid arthritis) which could place the subject at risk or interfere with the accuracy of the study results;
Has used any drugs or immunotherapy within the past 30days or 5 half-lives;
Is an employee of the sponsor company or clinical testing site;
Is diabetic;
Presents with the presence of an active or chronic allergic reaction as evidenced by an irregular white cell count determined by eosinophils > 0.3 X 109/L at Screening Visit;
Is planning a trip to a sunny climate, to use tanning booths or use other UV sources throughout the course of this study;
Has a history of hypersensitivity to any substance in preparation or to Desonide;
Has any medical condition or laboratory abnormality that would, in the opinion of the Investigator, put the patient at undue risk or interfere with the interpretation of the study results;
Is dependent on oral medication for any skin disease/condition or could not, in the opinion of the Investigator tolerate the restriction of discontinuing the medicine as required in this study;
Is currently pregnant or lactating or planning to become pregnant in the next 6 months;
Has other skin conditions that might interfere with AD diagnosis and/or evaluation (i.e. psoriasis current active viral, bacterial and fungal skin infections) as assessed by the Investigator;
Any other condition or factor the Investigator or their duly assigned representative believes may affect the ability of the subject to complete the study or the interpretation

Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 65 participants (actual)

Study arms

Experimental
Investigational OTC Cream
Investigational Over the Counter (OTC) Cream will be applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.
Drug: Investigational OTC Cream
Sham comparator
Placebo Cream
Placebo Cream will be applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
Other: Placebo Cream
Active comparator
0.05% Desonide Cream
Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions. Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.
Drug: 0.05% Desonide · Other: Placebo Cream

Interventions

DrugInvestigational OTC Cream
Investigational Over the Counter (OTC) Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.
Drug0.05% Desonide
Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions. Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.
Also known as: Desowen
OtherPlacebo Cream
Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
Also known as: Vehicle

06

What researchers measure

Primary outcomes

Severity Scoring of Atopic Dermatitis (SCORAD) Amongst Subjects With Moderate Atopic Dermatitis
SCORAD (Severity Scoring of Atopic Dermatitis) Change from Baseline to Week 8 of atopic dermatitis lesion as measured by the Scoring of Atopic Dermatitis (SCORAD). SCORAD is a composite severity index comprising a) the amount/extent of body area affected; b)b) 2 subjective symptom of pruritus (10 pts VAS) and sleep disturbance measured (10 pts VAS); and c) 6 disease intensity assessments \[Dryness/Scaling, Erythema, Excoriation, Induration/Papulation, Lichenification and Oozing/ Weeping/Crusting, each graded in 3pts TIS from 0 (None) to 3 (Severe). A SCORAD score ranges from 0 (No AD present) to 103 SCORAD is calculated: Extent 7\*Intensity SCORAD = --------- + ---------------- + Subjective 5 2
Time frame: Baseline to Week 8
Severity Scoring of Atopic Dermatitis (SCORAD) Amongst Subjects With Severe Atopic Dermatitis
SCORAD (Severity Scoring of Atopic Dermatitis) Change from Baseline to Week 8 of atopic dermatitis lesion as measured by the Scoring of Atopic Dermatitis (SCORAD). SCORAD is a composite severity index comprising a) the amount/extent of body area affected; b)b) 2 subjective symptom of pruritus (10 pts VAS) and sleep disturbance measured (10 pts VAS); and c) 6 disease intensity assessments \[Dryness/Scaling, Erythema, Excoriation, Induration/Papulation, Lichenification and Oozing/ Weeping/Crusting, each graded in 3pts TIS from 0 (None) to 3 (Severe). A SCORAD score ranges from 0 (No AD present) to 103 SCORAD is calculated: Extent 7\*Intensity SCORAD = --------- + ---------------- + Subjective 5 2
Time frame: Baseline to Week 8

07

Results

Posted Dec 17, 2020

Participant flow

Participant flow — Overall Study
Milestone	Investigational OTC Cream	Placebo Cream	0.05% Desonide Cream
Started	36	18	11
Completed	18	11	11
Not completed	18	7	0
Withdrew: Lack of efficacy	6	2	0
Withdrew: Adverse event	2	2	0
Withdrew: Withdrawal by subject	1	0	0
Withdrew: Lost to follow-up	9	3	0

Outcome measures

PrimarySeverity Scoring of Atopic Dermatitis (SCORAD) Amongst Subjects With Moderate Atopic Dermatitis

SCORAD (Severity Scoring of Atopic Dermatitis) Change from Baseline to Week 8 of atopic dermatitis lesion as measured by the Scoring of Atopic Dermatitis (SCORAD). SCORAD is a composite severity index comprising a) the amount/extent of body area affected; b)b) 2 subjective symptom of pruritus (10 pts VAS) and sleep disturbance measured (10 pts VAS); and c) 6 disease intensity assessments \[Dryness/Scaling, Erythema, Excoriation, Induration/Papulation, Lichenification and Oozing/ Weeping/Crusting, each graded in 3pts TIS from 0 (None) to 3 (Severe). A SCORAD score ranges from 0 (No AD present) to 103 SCORAD is calculated: Extent 7\*Intensity SCORAD = --------- + ---------------- + Subjective 5 2

Time frame:: Baseline to Week 8
Reported as:: Mean · units on a scale

Severity Scoring of Atopic Dermatitis (SCORAD) Amongst Subjects With Moderate Atopic Dermatitis
units on a scale	Investigational OTC Cream	Placebo Cream	0.05% Desonide Cream
Severity Scoring of Atopic Dermatitis (SCORAD) Amongst Subjects With Moderate Atopic Dermatitis	-12.2 ± 3.99	9.3 ± 6.51	-17.5 ± 8.29

Statistical analysis

Investigational OTC Cream vs Placebo Cream vs 0.05% Desonide Cream · ANCOVA · p = <0.05Model adjusted means.

PrimarySeverity Scoring of Atopic Dermatitis (SCORAD) Amongst Subjects With Severe Atopic Dermatitis

SCORAD (Severity Scoring of Atopic Dermatitis) Change from Baseline to Week 8 of atopic dermatitis lesion as measured by the Scoring of Atopic Dermatitis (SCORAD). SCORAD is a composite severity index comprising a) the amount/extent of body area affected; b)b) 2 subjective symptom of pruritus (10 pts VAS) and sleep disturbance measured (10 pts VAS); and c) 6 disease intensity assessments \[Dryness/Scaling, Erythema, Excoriation, Induration/Papulation, Lichenification and Oozing/ Weeping/Crusting, each graded in 3pts TIS from 0 (None) to 3 (Severe). A SCORAD score ranges from 0 (No AD present) to 103 SCORAD is calculated: Extent 7\*Intensity SCORAD = --------- + ---------------- + Subjective 5 2

Time frame:: Baseline to Week 8
Reported as:: Mean · units on a scale

Severity Scoring of Atopic Dermatitis (SCORAD) Amongst Subjects With Severe Atopic Dermatitis
units on a scale	Investigational OTC Cream	Placebo Cream	0.05% Desonide Cream
Severity Scoring of Atopic Dermatitis (SCORAD) Amongst Subjects With Severe Atopic Dermatitis	-6.0 ± 2.8	-20.3 ± 3.7	-18.0 ± 4.5

Statistical analysis

Investigational OTC Cream vs Placebo Cream vs 0.05% Desonide Cream · ANCOVA · p = <0.05Model adjusted means. Last Observation was Carried Forward (LOCF) for drops. Sporadic missing data were left miss

Adverse events

Collected over Adverse event data were collected during the subject's participation in the study (up to 8 weeks).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Investigational OTC Cream	0/36 (0%)	0/36 (0%)	2/36 (5.6%)
Placebo Cream	0/18 (0%)	0/18 (0%)	2/18 (11.1%)
0.05% Desonide Cream	0/11 (0%)	0/11 (0%)	0/11 (0%)

Most frequent other events

Most frequent other events
Event	Investigational OTC Cream	Placebo Cream	0.05% Desonide Cream
Atopic /OtherSkin and subcutaneous tissue disorders	2/36	2/18	0/11

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Investigational OTC Cream	Placebo Cream	0.05% Desonide Cream	Total
Mean	34.8 ± 13.5	39.6 ± 15.3	42 ± 15.4	37.3 ± 14.4

Sex: Female, Male
Sex: Female, Male(Participants)	Investigational OTC Cream	Placebo Cream	0.05% Desonide Cream	Total
Female	25	15	7	47
Male	11	3	4	18

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Investigational OTC Cream	Placebo Cream	0.05% Desonide Cream	Total
American Indian or Alaska Native	0	0	0	0
Asian	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	16	9	6	31
White	19	9	4	32
More than one race	1	0	1	2
Unknown or Not Reported	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Investigational OTC Cream	Placebo Cream	0.05% Desonide Cream	Total
United States	36	18	11	65

SCORAD
SCORAD(units on a scale)	Investigational OTC Cream	Placebo Cream	0.05% Desonide Cream	Total
Mean	49.18 ± 2.39	52.21 ± 3.36	45.22 ± 4.33	49.3 ± 14.1

08

Study locations

2 sites

Wake Research, LLC
Raleigh, North Carolina 27612, United States
WR (Wake Research) ClinSearch
Chattanooga, Tennessee 37421, United States

09

References and documents

Study documents

Study protocol ↗ · Apr 27, 2018
Statistical analysis plan ↗ · Apr 27, 2018

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID: NCT03386032
Lead sponsor: Procter and Gamble
Responsible party: Sponsor
First posted: Dec 29, 2017
Start date: Nov 27, 2017
Primary completion: Aug 18, 2018
Completion: Aug 18, 2018
Results posted: Dec 17, 2020
Last update: Dec 17, 2020

Study contacts

Amanda Salisbury, BSN

study director · Wake Research, LLC

Oversight

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

View the source record on ClinicalTrials.gov ↗

8-Week Atopic Dermatitis (AD) Treatment Study

Study summary

Conditions studied

Browse trials for

In context

Dermatitis, Atopic

Lead sponsor

Who can participate

Inclusion criteria

Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Study documents

Individual participant data

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

8-Week Atopic Dermatitis (AD) Treatment Study

Study summary

Conditions studied

Browse trials for

In context

Dermatitis, Atopic

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Study documents

Individual participant data

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria