NCT00305552

Brief Summary

Sarcoidosis is a multisystem disease involving most frequently the lung, the eyes, the lymph nodes and the skin. Skin lesions may be disfiguring and impair the quality of life. Thalidomide is a multi-target drug that has been shown to be of benefit in skin sarcoidosis in case reports. The objective is to assess the efficacy and tolerance of thalidomide in skin sarcoidosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 22, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

May 2, 2011

Status Verified

January 1, 2007

Enrollment Period

2.7 years

First QC Date

March 21, 2006

Last Update Submit

April 29, 2011

Conditions

Sarcoidosis

Keywords

Randomized controlled trialThalidomide vs placeboskin sarcoidosisThalidomide

Outcome Measures

Primary Outcomes (1)

  • Size of target skin lesions at 3 months.

    Size of target skin lesions at 3 months.

    during de study

Secondary Outcomes (1)

  • Physician global assessment at 3 months. Functional assessment of other organs. Side-effects at 3 months.

    during the study

Study Arms (1)

1

EXPERIMENTAL

THALIDOMIDE

Drug: THALIDOMIDE

Interventions

THALIDOMIDEDRUG

THALIDOMIDE

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy proven skin sarcoidosis
  • Assessable target skin lesions

You may not qualify if:

  • Rapidly evolving sarcoidosis
  • Patients necessitating a corticosteroid regimen of more than 15mg per day.
  • Women not willing to undertake a contraceptive method.
  • Neurologic impairment
  • Past treatment with Thalidomide
  • Renal impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HOPITAL Saint Louis, Service de Dermatologie

Paris, 75010, France

Location

Related Publications (1)

  • Droitcourt C, Rybojad M, Porcher R, Juillard C, Cosnes A, Joly P, Lacour JP, D'Incan M, Dupin N, Sassolas B, Misery L, Chevrant-Breton J, Lebrun-Vignes B, Desseaux K, Valeyre D, Revuz J, Tazi A, Chosidow O, Dupuy A. A randomized, investigator-masked, double-blind, placebo-controlled trial on thalidomide in severe cutaneous sarcoidosis. Chest. 2014 Oct;146(4):1046-1054. doi: 10.1378/chest.14-0015.

    PMID: 24945194DERIVED

MeSH Terms

Conditions

Sarcoidosis

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Michel RYBOJAD, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 21, 2006

First Posted

March 22, 2006

Study Start

February 1, 2005

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

May 2, 2011

Record last verified: 2007-01

Locations

FR(1)