Comparative Effectiveness Trial in the Treatment of Pediatric Plaque Morphea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a study designed to evaluate the comparative effectiveness of topical medications for the treatment of circumscribed morphea.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Musculoskeletal Effects of Isotretinoin During Acne Treatment in Pediatric Population

NCT00964119

Acne

TERMINATED

MC RCT - BPO vs Adapalene

NCT05536882

Molluscum Contagiosum

WITHDRAWN PHASE3

Imiquimod in Children With Plaque Morphea

NCT00147771

Scleroderma, Localized

COMPLETED PHASE3

Topical Sirolimus Ointment for Cutaneous Angiofibromas in Subjects With Tuberous Sclerosis Complex

NCT03363763

Angiofibroma of Face Tuberous Sclerosis

TERMINATED PHASE2

Topical Clobetasol for the Treatment of Toxic Epidermal Necrolysis

NCT02319616

Toxic Epidermal Necrolysis

WITHDRAWN PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Morphea, also known as localized scleroderma, is a rare autoimmune fibrosing disorder that affects children and adults. Morphea causes significant morbidity through atrophy and fibrosis of the skin and underlying structures. Treatment can halt the progression of disease but cannot reverse disease damage, leaving children with disfiguring scars and sometimes functional impairment. Consequently, it is of extreme importance to intervene early in the disease course with effective therapies to limit morbidity.

Circumscribed morphea is the second most common subtype in children, comprising approximately 1/3 of pediatric morphea cases. It is a disfiguring disease that can cause pain and pruritus. There are no FDA-approved treatments and no consensus exists on the ideal therapy for circumscribed morphea, either in adults or children. Most physicians use topical medications for circumscribed morphea yet there is little evidence to support these therapies. Topical immune modulators such as tacrolimus, imiquimod, and calcipotriene have been investigated in small studies, though these trials were limited by very small sample sizes of 9-19 patients and lack of a control in most. Surveys have demonstrated that topical steroids are the most commonly prescribed medication, even though the only evidence to support their use comes from case reports. With insufficient evidence regarding topical therapies, providers have no guidance when making treatment decisions, practice patterns vary widely even amongst pediatric dermatologists, and children continue with preventable scars.

The investigators specific aim is to identify effective topical therapy for circumscribed morphea. The investigators will utilize a comparative cohort study design to evaluate the comparative effectiveness of three topical medications: clobetasol ointment, calcipotriene ointment, and tacrolimus 0.1% ointment. The investigators will enroll subjects at CHW and other institutions to achieve the study enrollment necessary to power this study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Scleroderma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment 1

Calcipotriene 0.005% ointment

Group Type ACTIVE_COMPARATOR

Calcipotriene

Intervention Type DRUG

ointment, twice daily

Treatment 2

Clobetasol 0.05% ointment

Group Type ACTIVE_COMPARATOR

Clobetasol

Intervention Type DRUG

ointment, twice daily (alternating weeks)

Treatment 3

Tacrolimus 0.1% ointment

Group Type ACTIVE_COMPARATOR

Tacrolimus

Intervention Type DRUG

ointment, 0.1%, twice daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clobetasol

ointment, twice daily (alternating weeks)

Intervention Type DRUG

Calcipotriene

ointment, twice daily

Intervention Type DRUG

Tacrolimus

ointment, 0.1%, twice daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* presence of at least 1 active lesion of morphea on the neck, trunk, or extremities with no prior treatment to that lesion for at least 4 weeks

Exclusion Criteria

* children receiving phototherapy or systemic therapy for their morphea
* children with linear or generalized morphea
* lesions on the face
* greater than 3% body surface area involvement
* open or ulcerated skin within morphea lesions

Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No