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Comparing Aquaphor to Atopiclair and EpiCeram in Children With Mild to Moderate Atopic Dermatitis

Status and phase

Completed
Phase 4

Conditions

Atopic Dermatitis

Treatments

Drug: Atopiclair Nonsteroidal Cream
Other: Aquaphor Healing Ointment
Drug: EpiCeram

Study type

Interventional

Funder types

Other

Identifiers

NCT01093469
IRB00009130

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and cost effectiveness of Aquaphor Healing Ointment, Atopiclair and EpiCeram as a monotherapy in mild to moderate AD.

The investigators hypothesize that no statistical difference will exist in the efficacy between an over-the-counter moisturizer, Aquaphor Healing Ointment, compared to prescription devices Atopiclair and EpiCeram in treating mild to moderate AD. Therefore, Aquaphor will be most cost-effective than Atopiclair or EpiCeram.

Full description

The primary objective is to compare the efficacy of Aquaphor Healing Ointment, Atopiclair Nonsteroidal Cream and EpiCeram Skin Barrier Emulsion in children with mild to moderate atopic dermatitis. The secondary objective is to compare the cost-effectiveness of these products. A significant difference exists in the cost of these products; therefore, if our hypothesis is proved correct - that Aquaphor will be just as efficacious as the more expensive counterparts Atopiclair and EpiCeram - this could have a significant impact on the overall cost of treating atopic dermatitis.

This is a single center, investigator blinded, randomized, prospective controlled study of subjects with mild to moderate atopic dermatitis. The study is intended to compare the efficacy of Aquaphor Healing Ointment, Atopiclair Nonsteroidal Cream and the EpiCeram Skin Barrier Emulsion used three times a day in treating mild to moderate atopic dermatitis. All subjects will receive active study medication and will return to study center for efficacy and safety assessments at Days 7 and 21. Approximately 50 subjects will be enrolled in order to obtain 39 completed subjects that will be randomized 1:1:1 (13 to receive Aquaphor, 13 to receive Atopiclair and 13 to receive EpiCeram) according to standard randomization tables. Efficacy will be measured through Investigator's Global Assessment, BSA involvement, Investigator Global Assessment of Improvement, Eczema Area and Severity Index and 100-pt Visual Analog Score for pruritis. Subjects will complete a Subject Global Assessment of Improvement and a drug diary to monitor for compliance. Cost benefit analysis will be calculated as cost in dollars for change in outcome according to EASI, BSA and VAS.

Enrollment

39 patients

Sex

All

Ages

2 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female with mild to moderate atopic dermatitis, 2-17 years of age, that agree to participate and provide written consent (and assent if applicable)
  • Have an investigator Global Assessment of mild to moderate atopic dermatitis (IGA rating of 2-3 in the Investigator Global Assessment)
  • Percentage of overall body surface area of involvement (BSA) must be > 1% and may include facial and intertriginous skin.

Exclusion criteria

  • Use within 4 weeks of baseline of systemic anti-inflammatory medication, which may influence study outcome, such as systemic corticosteroids.
  • Application or use within 2 weeks of baseline of topical corticosteroid medications or topical anti-inflammatory medication, which may influence study outcome.
  • Presence of a concurrent medical condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments.
  • Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating int he study (oral antihistamines will be allowed, so long as they are neither initiated nor discontinued during the course of this study)
  • Amount of disease involvement that would require >60gm of cream in a 1 week period
  • Subjects with known allergy or sensitivity to Aquaphor Healing Ointment, Atopiclair or EpiCeram or components therein.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

39 participants in 3 patient groups

Aquaphor Healing Ointment
Experimental group
Description:
Aquaphor Healing Ointment three times daily to atopic dermatitis
Treatment:
Other: Aquaphor Healing Ointment
Atopiclair Nonsteroidal Cream
Active Comparator group
Description:
Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis
Treatment:
Drug: Atopiclair Nonsteroidal Cream
EpiCream Skin Barrier Emulsion
Active Comparator group
Description:
EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis
Treatment:
Drug: EpiCeram

Trial contacts and locations

1

There are currently no registered sites for this trial.

Timeline

Last updated: Sep 11, 2018

Start date

Sep 01, 2009 • 15 years ago

End date

Dec 01, 2009 • 15 years ago

Results posted

View

May 18, 2017 • 7 years ago

Today

May 04, 2025

Sponsor of this trial

Data sourced from clinicaltrials.gov