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Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema (HANDEL)

Primary Purpose

Eczema

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

alitretinoin

Placebo

About this trial

This is an interventional treatment trial for Eczema focused on measuring retinoid treatment, fingertip dermatitis, hyperkeratotic hand eczema, vesicular hand eczema, pompholyx

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

all types of chronic hand eczema, lasting for at least 6 months since initial diagnosis
rated as severe by the physician
unresponsive to highly potent topical corticosteroids, such as clobetasol

Exclusion Criteria:

patients whose disease is adequately controlled by standard non-medicated therapy, including potent topical steroids, skin moisturizers, and avoidance of allergens and irritants
patients with known allergens and irritants, who have not made a reasonable effort to avoid the substances
patients with psoriasis lesions
active fungal, bacterial or viral infections of the hands
female patients who are pregnant or breastfeeding
female patients of childbearing potential who cannot use or will not commit to use two effective methods of contraception

Sites / Locations

University of Alabama, Birmingham
Radiant Research Inc.
Johnson Dermatology
Dermatology Research of Arkansas
Hull Dermatology
Shahram Jacobs, MD, Inc.
University of California, San Diego Dermatology Clinical Trials Unit
Dermatology Research Associates
Laser and Dermatology Center
Integrated Research Group
University of California, Davis
Therapeutics Clinical Research
East Bay Psoriasis Treatment Center
Stanford University Dept of Dermatology
Solano Clinical Research, Dow Pharmaceutical Sciences
Longmont Clinic, P.C.
Western State Clinical Research Inc.
George Washington University - Medical Faculty Associates
Park Avenue Dermatology, PA
Palm Beach Research Center
Toccoa Clinic Medical Associates
Saltzer Medical Group
Michael Bukhalo MD
Dermassociates, Ltd
Schaumburg Dermatology
Dundee Dermatology
Deaconess Clinic, Inc.
Indiana University Dermatology
The Dermatology Center
Dermatology Center of Indiana/Indiana Clinical Trials Center
Kansas City Dermatology, PA
American Dermatology Association
Kansas Medical Clinic
Dermatology Specialists
Derm Research, PLLC
Tulane University Health Sciences, Dermatology Dept
Hamzavi Dermatology Clinic
Silverton Skin Institute
Grekin Skin Institute
MAPS Applied Research Center
Minnesota Clinical Studies Research Center
Washington University Dermatology Research
South Lincoln Dermatology
Dartmouth-Hitchcock Medical Center
UMDNJ - Robert Wood Johnson School of Medicine, Dermatology
St.Luke's/Roosevelt Hospital Center
Mount Sinai School of Medicine Clinical Dermatology
Helendale Dermatology and Medical Spa
Derm Research Center of New York Inc.
University of North Carolina, Dermatology Department
Azalea Research Center
Wake Forrest University School of Medicine
Bernstein Clinical Research Center
Oregon Dermatology and Research Center
Oregon Health and Science University
Paddington Testing Co.Inc
University of Pittsburgh Medical Center
Rhode Island Hospital
Dermatology Associates of Kingsport
Tennessee Clinical Research Center
Academy of Clinical Research
Modern Research Associates
Center for Clinical Studies
Dermatology Clinical Research Center of San Antonio
Center for Clinical Studies
Fletcher Allen Health Care
Virginia Clinical Research Inc.
Dermatology and Laser Center NW
Premier Clinical Research
Madison Skin & Research Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Alitretinoin

Placebo

Arm Description

Patients will receive alitretinoin 30mg capsule for up to 24 weeks

Patients will receive placebo 30mg capsule for up to 24 weeks

Outcomes

Primary Outcome Measures

Number of Participants Who Responded as Per Physician's Global Assessment (PGA) at Week 24

The investigator assigned PGA grades according to a 5-point scale (clear [not detectable], almost clear [less than 10% of affected hand surface], mild disease [less than 10% of affected hand surface], moderate disease [10% to 30% of affected hand surface], severe disease [>30% of affected hand surface]). PGA ratings were based on an integrated clinical picture of signs, symptoms, and the extent of disease. Symptoms included erythema, scaling, hyperkeratosis/lichenification, vesiculation, edema, fissures, and pruritus/pain. The PGA scale ranges from 0 (no symptom) to 4 (severe disease). Participants were considered as responders when they had a PGA of clear or almost clear.

Secondary Outcome Measures

Percentage Change From Baseline in Modified Total Lesion Symptom Score (mTLSS) at the End-of-treatment

A 4-point scale (0=none, 1=mild, 2=moderate, 3=severe) was used to grade 7 signs or symptoms of CHE. The mTLSS was calculated as sum of assigned scores for the symptoms of erythema, scaling, lichenification/hyperkeratosis, vesiculation, edema, fissures and Pruritus/Pain. The total score ranged from 0 (best) to 21 (worst). Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the individual post-baseline values. Percentage change from Baseline = (change from Baseline / Baseline value) * 100. Data for Week 24 last observation carried forward (LOCF) has been presented.

Number of Participants Who Responded as Per Patient Global Assessment (PaGA) at End-of-treatment

At Week 24 or at the end-of-treatment participants were asked by the investigator to grade their overall change from Baseline by selecting one of the following descriptions, which best matched their perception of overall treatment effect: cleared or almost cleared (at least 90% clearing), marked improvement (at least 75% clearing), moderate improvement (at least 50% clearing), mild improvement (at least 25% clearing), no change and worsening. Participants were considered as responders when the PaGa was cleared or almost cleared.

Percentage Change From Baseline in Extent of Disease at End-of-treatment

The extent of disease was estimated as the percentage of hand area (with 100% defined as the palmar and dorsal aspects) affected by eczema at Baseline, and at the end of treatment). Extent of disease was estimated separately for the left and right hands, and the overall extent of disease for both hands was calculated as (Left+Right)/2. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the individual post-baseline values. Percentage change from Baseline = (change from Baseline / Baseline value) * 100.

Response Duration for Responding Participants at the End-of-therapy

Response Duration was defined as time from the end-of-therapy to the first diagnosis of mild, moderate, or severe CHE. Median and inter-quartile range has been presented.

Time to Relapse for Responding Participants at the End-of-therapy

Time to relapse was defined as the time from end-of-therapy to the first diagnosis of severe CHE. Median and inter-quartile range has been presented. The median was based on the very last participant having a follow-up period longer than expected, those explaining the high median.

Time to Response for Responding Participants at End-of-therapy

Time to response was defined as time from start of treatment to first PGA assessment of "clear" or "almost clear". Median and inter-quartile range has been presented.

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period

An AE was defined as any adverse change from the participant's Baseline (pretreatment) clinical condition, including intercurrent illness, which occurred during the course of the clinical study after written informed consent had been given, whether considered related to treatment or not. A treatment-emergent AE was defined as any adverse change that occurred after treatment started and up to 7 days after last treatment. An SAE was any experience that suggested a significant hazard, contradiction, side effect or precaution. It was any adverse event that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect.

Number of Participants With Maximum Post Baseline Laboratory Values Outside the Marked Reference Range

Blood samples were collected for the assessment of laboratory parameters hemoglobin, hematocrit, erythrocytes, mean corpuscular volume, mean corpuscular hemoglobin concentration, reticulocytes, platelets, white blood cell, lymphocytes, neutrophils, monocytes, eosinophils, basophils, total bilirubin, bilirubin conjugated (direct), aspartate amino transferase (AST), alanine amino transferase (ALT), lactate dehydrogenase (LDH), creatine phosphokinase (CPK), alkaline phosphatase (ALP), total protein, serum albumin, glucose, triglycerides, total cholesterol, high-density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, sodium, potassium, chloride, serum calcium, serum phosphate, serum creatinine, blood urea nitrogen (BUN)/urea, uric acid, Free thyroxin and thyroid stimulating hormone (TSH) at Baseline and every 4 weeks of treatment period and Week 28 of follow up period. Data for participants with values outside the marked reference range are reported.

Number of Participants Referred or Not Referred to a Psychiatrist as Per Brief Summary Inventory (BSI) 53 Questionnaire up to 24 Weeks

The BSI is a 53 item self-report scale used to measure nine primary symptom dimensions (somatization, obsessive-compulsive behavior, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism). Respondents rank each feeling item (e.g., "your feelings being easily hurt") on a 5-point scale where, 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, 4=extremely (0 indicates best outcome and 4 indicates worst outcome). The total score ranged from 0 (best outcome) to 212 (worse outcome). Participants with an increase above Baseline of 25% or more on any domain subscore in BSI-53, or with an increase above Baseline of >=2 points or a score >=3 on any BSI-53 item that reflects depression, suicidality, psychotic symptoms, and hostility/aggression, were to be referred to a psychiatrist within 2 weeks.

Change From Baseline in Patient Health Questionnaire (PHQ-9) Score Over 28 Weeks

The PHQ-9 was a standardized tests of mood/depression. This was a nine item measure with a response for each item between 0-3 where, 0=not at all, 1= several days, 2= more than half the days, 3= nearly every day. Total scores on this measure range from 0-27, with 0 being a minimum indicating no depressive symptoms, and 27 being the maximum number and severity of depressive symptoms. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the individual post-baseline values.

Number of Participants Meeting the Referral Criteria of Psychiatric Evaluation Over 28 Weeks

Participants meeting any of the following criteria were to be referred for specialist psychiatric evaluation within 2 weeks: PHQ-9 Score >=15, Two Subsequent Scores of >=10 and PHQ-9 Question 9 >=1. The PHQ -9 was a standardized tests of mood/depression. This was a nine item measure with a response for each item between 0-3 where, 0=not at all, 1= several days, 2= more than half the days, 3= nearly everyday. Total scores on this measure range from 0-27, with 0 being a minimum indicating no depressive symptoms, and 27 being the maximum number and severity of depressive symptoms. Only categories with data available at the indicated time points have been presented. Categories with null values for all the arms have not been presented.

Change From Baseline in Hearing Handicap Inventory for the Elderly-Screening (HHIE-S) Over 24 Weeks

HHIE-S assessed participants by handicap category: no handicap (0 to 8 points); mild/moderate handicap (10 to 24 points); severe handicap (26-40 points). Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the individual post-baseline values.

Change From Baseline in Dizziness Handicap Inventory (DHI) Over 24 Weeks

DHI assessed participants by handicap category: no handicap (0 to 14 points); mild handicap (16 to 34 points); moderate handicap (36 to 52 points); severe handicap (54 points). Increase from Baseline of <6 points, 6 to <12 points and 12 points. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the individual post-baseline values.

Number of Participants Responding to Tinnitus Ototoxicity Monitoring Interview (TOMI) Questionnaire Over 24 Weeks

Participants who developed tinnitus were monitored by use of the TOMI. The numbers of participants with pre-existing tinnitus, new tinnitus, increased/decreased loudness of tinnitus, or increased/decreased duration of tinnitus, pulsing quality of tinnitus were assessed.

Percent Change From Baseline in Bone Mineral Density (BMD) by Dual Energy X-ray Absorptiometry (DXA) Over 72 Weeks

Bone mineral density scans of the left proximal femur (total hip) and anterior-posterior lumbar spine were obtained by use of DXA, at Baseline, at end of therapy, and 1 year (48 weeks) after end of therapy. In case of abnormality or surgery of the left hip, the right hip was to be used. If both hips were affected, the participant was not eligible for DXA. Vertebrae L1 to L4 had to be completely scanned. At least 3 vertebrae had to be free of any abnormalities potentially interfering with DXA analysis (eg, fractures, large osteophytes), otherwise the participant was not eligible for DXA. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the individual post-baseline values. Percentage change from Baseline = (change from Baseline / Baseline value) * 100. Least square means and 95% confidence interval has been presented.

Number of Participants With Adequecy of Images Assessed by X-ray Evaluation of Bones

X-ray evaluations was done at Baseline (Week 0), end of therapy and at follow up period (Week 72). X-ray evaluations was done for Lateral C-Spine, Lateral T-Spine and Calcaneous. The images were evaluated as optimal, readable (but not optimal) or not readable.

Number of Participants With Adverse Ophthalmological Change as Assessed by Fundus Photography - Intraocular Pressure

An adverse change was defined as a change from normal at Baseline to abnormal at end of therapy, or as a worsening from Baseline for either or both eyes. A missing adverse change was defined as missing results at Baseline and end of therapy, or missing result at Baseline and abnormal at end of therapy, or normal at Baseline and missing result at end of therapy, or abnormal at Baseline and missing result at end of therapy, for both eyes or one eye when the other eye was not concerned by an adverse change. Other changes from Baseline to end of therapy was considered as no adverse change. Optic disc, macula, and retinal periphery were assessed by fundoscopy after pupil dilation using tropicamide.

Number of Participants With Adverse Audiological Change as Assessed by Puretone Audiogram at Highest Frequency

An adverse change was defined as a change from normal at Baseline to abnormal at end of therapy. A missing adverse change was defined as missing results at Baseline and end of therapy, or missing result at Baseline and abnormal at end of therapy, or normal at Baseline and missing result at end of therapy. Other changes from Baseline to end of therapy are considered as no adverse change. All puretone testing used a modified Hughson-Westlake procedure with 5 decibel (dB) step size.

Full Information

NCT ID

NCT00817063

First Posted

January 5, 2009

Last Updated

April 10, 2020

Sponsor

Stiefel, a GSK Company

Collaborators

Basilea Pharmaceutica

1. Study Identification

Unique Protocol Identification Number

NCT00817063

Brief Title

Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema

Acronym

HANDEL

Official Title

Efficacy and Safety of Alitretinoin in the Treatment of Severe Chronic Hand Eczema Refractory to Topical Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

January 8, 2009 (Actual)

Primary Completion Date

April 26, 2012 (Actual)

Study Completion Date

April 26, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stiefel, a GSK Company

Collaborators

Basilea Pharmaceutica

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to investigate the safety and efficacy of alitretinoin in the treatment of severe chronic hand eczema that does not respond to treatment with potent topical steroids.

Detailed Description

Chronic hand eczema (CHE)is a distressing disease that poses difficult problems for dermatologists. CHE leads to considerable work-absenteeism, disability and exclusion from labour market. Conventional treatments, including highly potent topical steroids, yield often unsatisfactory results. This study investigates the efficacy and safety of oral alitretinoin, a retinoid, in patients who have not responded to avoidance of causative factors, such as contact allergens and skin irritants, non-medicated skin care and highly potent topical steroids. Eligible patients are randomly assigned to receive alitretinoin or a placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eczema

Keywords

retinoid treatment, fingertip dermatitis, hyperkeratotic hand eczema, vesicular hand eczema, pompholyx

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

599 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Alitretinoin

Arm Type

Experimental

Arm Description

Patients will receive alitretinoin 30mg capsule for up to 24 weeks

Arm Title

Placebo

Arm Type

Experimental

Arm Description

Patients will receive placebo 30mg capsule for up to 24 weeks

Intervention Type

Drug

Intervention Name(s)

alitretinoin

Intervention Description

Patients receive alitretinoin 30mg one capsule daily for up to 24 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Patients receive matching placebo for up to 24 weeks

Primary Outcome Measure Information:

Title

Number of Participants Who Responded as Per Physician's Global Assessment (PGA) at Week 24

Description

Time Frame

Week 24 (end-of-treatment)

Secondary Outcome Measure Information:

Title

Percentage Change From Baseline in Modified Total Lesion Symptom Score (mTLSS) at the End-of-treatment

Description

Time Frame

Baseline (Week 0) and Week 24 (end-of-treatment)

Title

Number of Participants Who Responded as Per Patient Global Assessment (PaGA) at End-of-treatment

Description

Time Frame

Week 24 (end-of-treatment)

Title

Percentage Change From Baseline in Extent of Disease at End-of-treatment

Description

Time Frame

Baseline (Week 0) and Week 24 (end-of-treatment)

Title

Response Duration for Responding Participants at the End-of-therapy

Description

Response Duration was defined as time from the end-of-therapy to the first diagnosis of mild, moderate, or severe CHE. Median and inter-quartile range has been presented.

Time Frame

Up to 72 Weeks (including 24 weeks of treatment and 48 weeks of follow-up)

Title

Time to Relapse for Responding Participants at the End-of-therapy

Description

Time Frame

Up to 72 Weeks (including 24 weeks of treatment and 48 weeks of follow-up)

Title

Time to Response for Responding Participants at End-of-therapy

Description

Time to response was defined as time from start of treatment to first PGA assessment of "clear" or "almost clear". Median and inter-quartile range has been presented.

Time Frame

Up to 72 Weeks (including 24 weeks of treatment and 48 weeks of follow-up)

Title

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period

Description

Time Frame

Up to Week 24 (end-of-treatment)

Title

Number of Participants With Maximum Post Baseline Laboratory Values Outside the Marked Reference Range

Description

Time Frame

Up to Week 28

Title

Number of Participants Referred or Not Referred to a Psychiatrist as Per Brief Summary Inventory (BSI) 53 Questionnaire up to 24 Weeks

Description

Time Frame

Up to Week 24

Title

Change From Baseline in Patient Health Questionnaire (PHQ-9) Score Over 28 Weeks

Description

Time Frame

Baseline (Week 0) and Week 4, 8, 12, 16, 20, 24, 28

Title

Number of Participants Meeting the Referral Criteria of Psychiatric Evaluation Over 28 Weeks

Description

Time Frame

Up to 28 Weeks

Title

Change From Baseline in Hearing Handicap Inventory for the Elderly-Screening (HHIE-S) Over 24 Weeks

Description

Time Frame

Baseline (Week 0) and Week 4, 8, 12, 16, 20, 24

Title

Change From Baseline in Dizziness Handicap Inventory (DHI) Over 24 Weeks

Description

Time Frame

Baseline (Week 0) and Week 4, 8, 12, 16, 20, 24

Title

Number of Participants Responding to Tinnitus Ototoxicity Monitoring Interview (TOMI) Questionnaire Over 24 Weeks

Description

Time Frame

Up to Week 24

Title

Percent Change From Baseline in Bone Mineral Density (BMD) by Dual Energy X-ray Absorptiometry (DXA) Over 72 Weeks

Description

Time Frame

Baseline (Week 0) and Week 72

Title

Number of Participants With Adequecy of Images Assessed by X-ray Evaluation of Bones

Description

Time Frame

Up to Week 72

Title

Number of Participants With Adverse Ophthalmological Change as Assessed by Fundus Photography - Intraocular Pressure

Description

Time Frame

Up to Week 24

Title

Number of Participants With Adverse Audiological Change as Assessed by Puretone Audiogram at Highest Frequency

Description

Time Frame

Up to Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: all types of chronic hand eczema, lasting for at least 6 months since initial diagnosis rated as severe by the physician unresponsive to highly potent topical corticosteroids, such as clobetasol Exclusion Criteria: patients whose disease is adequately controlled by standard non-medicated therapy, including potent topical steroids, skin moisturizers, and avoidance of allergens and irritants patients with known allergens and irritants, who have not made a reasonable effort to avoid the substances patients with psoriasis lesions active fungal, bacterial or viral infections of the hands female patients who are pregnant or breastfeeding female patients of childbearing potential who cannot use or will not commit to use two effective methods of contraception

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

University of Alabama, Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Facility Name

Radiant Research Inc.

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85710

Country

United States

Facility Name

Johnson Dermatology

City

Fort Smith

State/Province

Arkansas

ZIP/Postal Code

72916

Country

United States

Facility Name

Dermatology Research of Arkansas

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Hull Dermatology

City

Rogers

State/Province

Arkansas

ZIP/Postal Code

72758

Country

United States

Facility Name

Shahram Jacobs, MD, Inc.

City

Encino

State/Province

California

ZIP/Postal Code

91436

Country

United States

Facility Name

University of California, San Diego Dermatology Clinical Trials Unit

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Dermatology Research Associates

City

Los Angeles

State/Province

California

ZIP/Postal Code

90045

Country

United States

Facility Name

Laser and Dermatology Center

City

Marina Del Rey

State/Province

California

ZIP/Postal Code

90292

Country

United States

Facility Name

Integrated Research Group

City

Riverside

State/Province

California

ZIP/Postal Code

92506

Country

United States

Facility Name

University of California, Davis

City

Sacramento

State/Province

California

ZIP/Postal Code

95816

Country

United States

Facility Name

Therapeutics Clinical Research

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

East Bay Psoriasis Treatment Center

City

San Ramon

State/Province

California

ZIP/Postal Code

94583

Country

United States

Facility Name

Stanford University Dept of Dermatology

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Solano Clinical Research, Dow Pharmaceutical Sciences

City

Vallejo

State/Province

California

ZIP/Postal Code

94589

Country

United States

Facility Name

Longmont Clinic, P.C.

City

Longmont

State/Province

Colorado

ZIP/Postal Code

80501

Country

United States

Facility Name

Western State Clinical Research Inc.

City

Wheat Ridge

State/Province

Colorado

ZIP/Postal Code

80033

Country

United States

Facility Name

George Washington University - Medical Faculty Associates

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20037

Country

United States

Facility Name

Park Avenue Dermatology, PA

City

Orange Park

State/Province

Florida

ZIP/Postal Code

32073

Country

United States

Facility Name

Palm Beach Research Center

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33409

Country

United States

Facility Name

Toccoa Clinic Medical Associates

City

Toccoa

State/Province

Georgia

ZIP/Postal Code

30577

Country

United States

Facility Name

Saltzer Medical Group

City

Nampa

State/Province

Idaho

ZIP/Postal Code

83687

Country

United States

Facility Name

Michael Bukhalo MD

City

Arlington Heights

State/Province

Illinois

ZIP/Postal Code

60005

Country

United States

Facility Name

Dermassociates, Ltd

City

Belleville

State/Province

Illinois

ZIP/Postal Code

62226

Country

United States

Facility Name

Schaumburg Dermatology

City

Schaumburg

State/Province

Illinois

ZIP/Postal Code

60194

Country

United States

Facility Name

Dundee Dermatology

City

West Dundee

State/Province

Illinois

ZIP/Postal Code

60118

Country

United States

Facility Name

Deaconess Clinic, Inc.

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47713

Country

United States

Facility Name

Indiana University Dermatology

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

37660

Country

United States

Facility Name

The Dermatology Center

City

New Albany

State/Province

Indiana

ZIP/Postal Code

47150

Country

United States

Facility Name

Dermatology Center of Indiana/Indiana Clinical Trials Center

City

Plainfield

State/Province

Indiana

ZIP/Postal Code

46168

Country

United States

Facility Name

Kansas City Dermatology, PA

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66215

Country

United States

Facility Name

American Dermatology Association

City

Shawnee Mission

State/Province

Kansas

ZIP/Postal Code

66216

Country

United States

Facility Name

Kansas Medical Clinic

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66614

Country

United States

Facility Name

Dermatology Specialists

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Derm Research, PLLC

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40217

Country

United States

Facility Name

Tulane University Health Sciences, Dermatology Dept

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

Facility Name

Hamzavi Dermatology Clinic

City

Fort Gratiot

State/Province

Michigan

ZIP/Postal Code

48059

Country

United States

Facility Name

Silverton Skin Institute

City

Grand Blanc

State/Province

Michigan

ZIP/Postal Code

48439

Country

United States

Facility Name

Grekin Skin Institute

City

Warren

State/Province

Michigan

ZIP/Postal Code

48088

Country

United States

Facility Name

MAPS Applied Research Center

City

Edina

State/Province

Minnesota

ZIP/Postal Code

55435

Country

United States

Facility Name

Minnesota Clinical Studies Research Center

City

Fridley

State/Province

Minnesota

ZIP/Postal Code

55432

Country

United States

Facility Name

Washington University Dermatology Research

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

South Lincoln Dermatology

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68502

Country

United States

Facility Name

Dartmouth-Hitchcock Medical Center

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

UMDNJ - Robert Wood Johnson School of Medicine, Dermatology

City

Somerset

State/Province

New Jersey

ZIP/Postal Code

08873

Country

United States

Facility Name

St.Luke's/Roosevelt Hospital Center

City

New York

State/Province

New York

ZIP/Postal Code

10025

Country

United States

Facility Name

Mount Sinai School of Medicine Clinical Dermatology

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Helendale Dermatology and Medical Spa

City

Rochester

State/Province

New York

ZIP/Postal Code

14609

Country

United States

Facility Name

Derm Research Center of New York Inc.

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11790

Country

United States

Facility Name

University of North Carolina, Dermatology Department

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

918-843-9447

Country

United States

Facility Name

Azalea Research Center

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28403

Country

United States

Facility Name

Wake Forrest University School of Medicine

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Bernstein Clinical Research Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

Oregon Dermatology and Research Center

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Oregon Health and Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Paddington Testing Co.Inc

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19103

Country

United States

Facility Name

University of Pittsburgh Medical Center

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Rhode Island Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Facility Name

Dermatology Associates of Kingsport

City

Kingsport

State/Province

Tennessee

ZIP/Postal Code

37660

Country

United States

Facility Name

Tennessee Clinical Research Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37215

Country

United States

Facility Name

Academy of Clinical Research

City

Arlington

State/Province

Texas

ZIP/Postal Code

76011

Country

United States

Facility Name

Modern Research Associates

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Center for Clinical Studies

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Dermatology Clinical Research Center of San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

77056

Country

United States

Facility Name

Center for Clinical Studies

City

Webster

State/Province

Texas

ZIP/Postal Code

77598

Country

United States

Facility Name

Fletcher Allen Health Care

City

Burlington

State/Province

Vermont

ZIP/Postal Code

05401

Country

United States

Facility Name

Virginia Clinical Research Inc.

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Facility Name

Dermatology and Laser Center NW

City

Bellingham

State/Province

Washington

ZIP/Postal Code

98281

Country

United States

Facility Name

Premier Clinical Research

City

Seattle

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

Madison Skin & Research Inc.

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53719

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing Time Frame

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing Access Criteria

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing URL

https://clinicalstudydatarequest.com/Posting.aspx?ID=20099

Citations:

PubMed Identifier

17868211

Citation

Diepgen TL, Agner T, Aberer W, Berth-Jones J, Cambazard F, Elsner P, McFadden J, Coenraads PJ. Management of chronic hand eczema. Contact Dermatitis. 2007 Oct;57(4):203-10. doi: 10.1111/j.1600-0536.2007.01179.x.

Results Reference

background

PubMed Identifier

15611422

Citation

Ruzicka T, Larsen FG, Galewicz D, Horvath A, Coenraads PJ, Thestrup-Pedersen K, Ortonne JP, Zouboulis CC, Harsch M, Brown TC, Zultak M. Oral alitretinoin (9-cis-retinoic acid) therapy for chronic hand dermatitis in patients refractory to standard therapy: results of a randomized, double-blind, placebo-controlled, multicenter trial. Arch Dermatol. 2004 Dec;140(12):1453-9. doi: 10.1001/archderm.140.12.1453.

Results Reference

background

PubMed Identifier

18294310

Citation

Ruzicka T, Lynde CW, Jemec GB, Diepgen T, Berth-Jones J, Coenraads PJ, Kaszuba A, Bissonnette R, Varjonen E, Hollo P, Cambazard F, Lahfa M, Elsner P, Nyberg F, Svensson A, Brown TC, Harsch M, Maares J. Efficacy and safety of oral alitretinoin (9-cis retinoic acid) in patients with severe chronic hand eczema refractory to topical corticosteroids: results of a randomized, double-blind, placebo-controlled, multicentre trial. Br J Dermatol. 2008 Apr;158(4):808-17. doi: 10.1111/j.1365-2133.2008.08487.x. Epub 2008 Feb 21.

Results Reference

background

PubMed Identifier

25607554

Citation

Fowler JF, Graff O, Hamedani AG. A phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of alitretinoin (BAL4079) in the treatment of severe chronic hand eczema refractory to potent topical corticosteroid therapy. J Drugs Dermatol. 2014 Oct;13(10):1198-204.

Results Reference

derived

Learn more about this trial

Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema

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