Blinded, Randomized Study Evaluating Aurstat Versus Control in the Treatment of Atopic Dermatitis Associated Pruritus

NCT01905631 | Completed Phase 2 Results

• 1 other identifier: AUR0613
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To demonstrate the ability of Aurstat to reduce pruritus in subjects with mild to moderate atopic dermatitis. Efficacy results will be based on subject assessment, IGA, and photographic evidence based on ordinal scales for tolerability.

Conditions

Pruritus; Atopic Dermatitis

Keywords

Pruritus; Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Reduction of Itching in AD

  The ability of Aurstat to reduce itching in those diagnosed with Atopic Dermatitis aged 12-75 years of age. Visual analog score (VAS assessment)- the VAS itch score was defined as the number of millimeters from the left side of a line (154 mm in length) that indicates their level of itching (0 mm (no itching)-154 mm (most itching)).

  3-days

Study Arms (2)

Untreated Control Group

NO INTERVENTION

Subjects will apply nothing for the entire three days of the trial. Subjects will also fill out a study diary assessing adverse events or other events they experience during the trial.

Treatment Group (Aurstat)

ACTIVE COMPARATOR

Subjects will apply Aurstat Anti-Itch Hydrogel 2 times daily or as needed for up to three days to reduce itching. Subjects will also fill out a study diary assessing adverse events or other events they experience during the trial.

Drug: Aurstat Anti-Itch Hydrogel (Aurstat)

Interventions

Aurstat Anti-Itch Hydrogel (Aurstat) DRUG

Subjects will apply Aurstat Anti-Itch Hydrogel 2 times daily or as needed for up to three days to reduce itching. Subjects will also fill out a study diary assessing adverse events or other events they experience during the trial.

Treatment Group (Aurstat)

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who meet all of the following criteria are eligible for this study.
• Subjects must be diagnosed by the investigator as meeting the criteria for mild to moderate atopic dermatitis, as defined by the Hanifin criteria.
• Subjects must score a minimum of 2 on the itch severity scale.
• Subjects may not apply other topical products (including moisturizers) to the affected lesions, other than study treatments, for a minimum of 24 hours prior to study initiation and for the duration of the study.
• No other oral or topical treatments for atopic dermatitis are allowed during the study.
• Subjects on asthma or allergy medications must continue taking these prescription or OTC products without change during the study.
• Anti-inflammatory oral medications or oral antihistamines not used at cannot be added during the study or taken on an intermittent basis.
• Subjects must be 12-75 years of age with no known medical conditions that, in the investigator's opinion, may interfere with study participation, except mild to moderate atopic dermatitis.
• Women of childbearing potential must be willing to use a form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, Norplant, Depo-Provera, double barrier methods (e.g., condom and spermicide), and abstinence.

You may not qualify if:

• Patients who meet any of the following criteria are not eligible for this study.
• Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's response to the study formulation.
• Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study product.
• Concurrent therapy with any medication either topical or oral that might interfere with the investigator and/or subject assessments of atopic dermatitis or study product irritancy, based on the opinion of the investigator.
• Subjects who have used a topical corticosteroid within 2 weeks of study enrollment.
• Subjects who are on oral corticosteroids within 4 weeks of study enrollment, inhaled corticosteroids are allowed if used at baseline and used on a routine basis. Intermittent inhaled corticosteroids are prohibited.
• Subjects who use an indoor tanning booth.
• Subjects who are pregnant, breast feeding or planning a pregnancy.
• Subjects with clinically significant unstable medical disorders.

Sponsors & Collaborators

• The Center for Clinical and Cosmetic Research: lead
• Onset Dermatologics, Inc.: collaborator

Study Sites (1)

Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

Location

MeSH Terms

Conditions

Pruritus; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr. Mark Nestor
• Organization: Center for Clinical and Cosmetic Research

nestormd@admcorp.com

3059336716

Study Officials

• Brian Berman, MD, PhD

  Center for Clinical and Cosmetic Research

  PRINCIPAL INVESTIGATOR

• Mark S. Nestor, MD, PhD

  Center for Clinical and Cosmetic Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 19, 2013
• First Posted: July 23, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 24, 2022
• Results First Posted: October 24, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)