Skin Effects of a Topical Amino Acid Moisturizing Cream and Desonide in Atopic Dermatitis

November 10, 2014 updated by: NeoStrata Company, Inc.

A Randomized, Double-Blind, Active Control, 5 Week Study to Evaluate the Safety and Skin Effects of A New, Twice-daily, Topically Applied Amino Acid Moisturizing Cream vs. Desonide Cream in Adult Atopic Dermatitis

The purpose of this study is to compare the effects of an amino acid moisturizing cream and desonide cream in reducing skin symptoms associated with AD/eczema in subjects with mild to moderate atopic dermatitis/eczema.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a double-blind, randomized study comparing the effects of an amino acid moisturizing cream and desonide cream in reducing skin symptoms associated with AD/eczema in subjects with mild to moderate atopic dermatitis/eczema. Atopic dermatitis (AD), also known as Eczema, is a chronic inflammatory skin disease that most commonly affects infants and children with a prevalence of 10-20% in children as compared to 1-3% in adults. Patients with AD have dry, irritated skin and often experience severe pruritus. Treatment of AD involves avoidance of triggers and infectious agents, cutaneous hydration, control of pruritus, and anti-inflammatory agents. Topical calcineurin inhibitors and steroids are commonly used prescription anti-inflammatory treatments. Unfortunately, there are potential side effects of long-term topical glucocorticoid use including skin atrophy, development of striae, perioral dermatitis, acne, and even hypothalamic-pituitary-adrenal axis suppression. However, many moisturizers are available without a prescription to soothe skin and reduce symptoms associated with AD/eczema via increased hydration, improved barrier function and anti-irritancy effects. The study cream being compared to desonide is a cosmetic moisturizing formulation that contains a cosmetic amino acid dipeptide (e.g., contains 2 amino acids). This study is being conducted to understand the benefits of the amino acid dipeptide moisturizing cream versus dermatologist-prescribed desonide cream in reducing the symptoms associated with AD/eczema in order to evaluate its potential use in the eczema care market. For this study, approximately 60 males and females, 18 years of age and older, who are in general good health, but diagnosed with mild to moderate AD/eczema, will be recruited, screened, and fully consented, with the goal of enrolling up to 42 evaluable subjects. The 42 Subjects (21 subjects per group) will be randomly and equally assigned to either one of 2 treatment groups of amino acid moisturizing cream or desonide cream. Neither study subjects nor study staff will be aware of the treatment assigned. The subjects will be asked to participate for approximately 5 weeks, over 5 study visits: Screening/Baseline, Weeks 1-3 (Treatment Period), Regression weeks 4 & 5. Each subject will receive one, 15 gram, blinded study cream at each treatment visit to apply twice daily at home for 3 weeks; a 2-week regression phase of no study cream will follow the treatment phase. A predetermined target lesion will be assessed at each time point via established clinical grading scales including: Target lesion Atopic Dermatitis Severity Index (TADSI), Eczema Area Severity Index (EASI), Static IGA of targeted lesion, Total IGA (PGA) and Body Surface Area involvement. All grading will be completed by the principal or sub-investigators. Photographs will also be taken at each time point to assess changes during the treatment and regression phases. Other established scales will be utilized to collect patient perception of skin effects such as: Patient-Oriented Eczema Measure (POEM), subjects' assessment of pruritus (VAS); a self-assessment questionnaire will be utilized to collect information on perceived benefits and product aesthetics. This study has been IRB approved and is scheduled to begin November of 2014 at Massachusetts General Hospital, specifically at the Clinical Unit for Research Trials in Skin (CURTIS) under principal investigator, Alexandra B. Kimball, MD. The study is being sponsored by NeoStrata Company, Inc, Princeton, NJ.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Mass General Hospital: Clinical Unit for Research Trials in Skin
        • Contact:
        • Principal Investigator:
          • Alexandra B Kimball, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female subjects in general good health 18 years of age or older
  2. Diagnosis of atopic dermatitis will be made based on clinical criteria. Each patient must have at least one eczematous target lesion with area ranging from 10-500 cm2 of mild to moderate severity with a grade of at least 6 on the TADSI scale, plus presence of itch
  3. Body surface area affected by AD lesions: ≤ 5% at start of treatment

Exclusion Criteria:

  1. Pregnancy or breastfeeding
  2. Any condition or therapy that in the investigator's opinion may pose a risk to the subject or that could interfere with any evaluation in the study
  3. Widespread AD requiring systemic therapy
  4. Diagnosis of allergic contact dermatitis
  5. Known hypersensitivity to any of the constituents or excipients of the investigational product
  6. Diagnosed with immunocompromised status
  7. Use of systemic AD therapy, e.g. systemic corticosteroids, cyclosporine A, azathioprine, mycophenolate mofetil, or phototherapy in the past 1 month.
  8. Use of phototherapy in the past 2 weeks
  9. Use of any topical AD therapy such as corticosteroids or topical immunomodulators in the past 2 weeks
  10. Use of local anti-itch or medical device treatments, e.g. benadryl, atopiclair, epiceram in the past 2 weeks
  11. Use of topical moisturizers less than 24 hours in advance of the baseline visit on eczema lesions
  12. Participation in another clinical research study with an investigational drug within 4 weeks before randomization in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Desonide Group
Group randomly receiving desonide cream as the treatment cream for 3 weeks. Fifteen (15) gram tubes are dispensed at the beginning of each week and will be applied twice daily, by the subject, during the 3 week treatment phase.
Drug: Desonide Cream
Study cream randomized and distributed to subjects, applied twice daily for 3 weeks and evaluated ability to reduce atopic dermatitis symptoms.
Other Names:
  • Desonide Cream 0.05%
Experimental: Amino Acid Group
Group randomly receiving amino acid moisturizing cream as the treatment cream for 3 weeks. Fifteen (15) gram tubes are dispensed at the beginning of each week and will be applied twice daily, by the subject, during the 3 week treatment phase.
Other: Amino Acid Moisturizing Cream
Study cream randomized and distributed to subjects, applied twice daily for 3 weeks and evaluated ability to reduce atopic dermatitis symptoms.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in skin effects of an amino acid moisturizing cream and desonide cream in reducing skin symptoms associated with AD/eczema in subjects with mild to moderate atopic dermatitis/eczema.
Time Frame: 5 weeks
Change in erythema, pruritus, exudation, excoriation and Lichenification from baseline of atopic dermatitis target lesions after application of either amino acid moisturizing cream or desonide cream twice daily for three weeks.
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NeoStrata Company, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Massachusetts General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alexandra Kimball, MD, Massachusetts General Hospital: Clinical Unit for Research Trials in Skin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 11, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14-ECD108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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