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Efficacy Study Between Two Different Dosages of an Antiparasitic in Patients With Crusted Scabies (GALECRUSTED)

Primary Purpose

Gale, Severe Forms of Scabies, Oral Parasitic Drug

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Ivermectin 200 µg/kg
Ivermectin 400 µg/kg
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gale focused on measuring Gale, Severe forms of scabies, Oral parasitic drug, Ivermectin

Eligibility Criteria

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

Inclusion Criteria:

Patients ≥ 18 years old, diagnosed with severe forms of scabies

  1. clinical criteria : cutaneous lesions of scabies

    • crusted scabies: at least two sites of hyperkeratosis will define crusted scabies and/or
    • profuse scabies : spreading lesions with erythematous scaly eruption of the neck, face or trunk without hyperkeratosis

  2. paraclinical criteria:

    • Positive parasitological test
    • and/or dermoscopic exam with signs of scabies

Effective contraception for women in age of pregnancy Written consent from patient or his/her legal representant, trustworthy person or family member Affiliated to a social security scheme

Exclusion Criteria:

  • Pregnant and/or breastfeeding women
  • Intolerance to ivermectin or topical treatment (permethrin 5% cream) or emollient cream
  • Use of anti parasitic drug (ivermectin or albendazole) within the past 7 days
  • Abnormal liver test results: ALT and/or AST >3N within the past 7 days (within 6 months if no hepatic history)
  • Participation in other biomedical drug research
  • Patient deprived of freedom
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Sites / Locations

  • Henri Mondor Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oral ivermectin 400 µg/kg

Oral ivermectin 200 µg/kg

Arm Description

Oral ivermectin 400 µg/kg + topical treatment (permethrin 5% cream) + emollient cream (Dexeryl® or other)

Oral ivermectin 200 µg/kg + topical treatment (permethrin 5% cream) + emollient cream (Dexeryl® or other)

Outcomes

Primary Outcome Measures

Rate of a successful treatment defined by : -Two negative parasitologic and/or two dermoscopic exams
Parasitologic and/or dermoscopic exams will be perform at days 18 +/-2days and at days 21+/-2 days
Rate of a successful treatment defined by : - A clinical response : disappearance of clinical active lesions

Secondary Outcome Measures

Rate of adverse effects

Full Information

First Posted
June 30, 2016
Last Updated
September 21, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02841215
Brief Title
Efficacy Study Between Two Different Dosages of an Antiparasitic in Patients With Crusted Scabies
Acronym
GALECRUSTED
Official Title
A Randomized Controlled Double-blind Trial Assessing the Efficacy of a 400µg/kg Ivermectin /5% Permethrin / Emollient Cream Regimen in Patients With Crusted Scabies as Compared to a 200µg/kg Ivermectin /5% Permethrin /Emollient Cream Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 11, 2017 (Actual)
Primary Completion Date
January 12, 2022 (Actual)
Study Completion Date
January 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Severe forms of scabies (crusted scabies and profuse scabies) require a specific treatment. Ivermectin is a recommended treatment in common forms of scabies and represents a promising treatment in crusted scabies in case reports. However, response to ivermectin remains variable among studies, and there is no consensus on the schemes to adopt (dosages and administrations). Ivermectin at 400 µg/kg has already been used, without showing toxicity (in head lice treatment in particular). Investigators propose to demonstrate that 400µg/kg ivermectin dosage will show better efficacy than a 200µg/kg in patients with severe forms of scabies (crusted and profuse).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gale, Severe Forms of Scabies, Oral Parasitic Drug, Ivermectin
Keywords
Gale, Severe forms of scabies, Oral parasitic drug, Ivermectin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral ivermectin 400 µg/kg
Arm Type
Experimental
Arm Description
Oral ivermectin 400 µg/kg + topical treatment (permethrin 5% cream) + emollient cream (Dexeryl® or other)
Arm Title
Oral ivermectin 200 µg/kg
Arm Type
Active Comparator
Arm Description
Oral ivermectin 200 µg/kg + topical treatment (permethrin 5% cream) + emollient cream (Dexeryl® or other)
Intervention Type
Drug
Intervention Name(s)
Ivermectin 200 µg/kg
Intervention Description
Oral ivermectin 200 µg/kg three times (D0, D7 and D14) + topical treatment (permethrin 5% cream) on skin, hair and genital organs (D0 and D7) + emollient cream (Dexeryl® or other) daily on skin (D0 to D28)
Intervention Type
Drug
Intervention Name(s)
Ivermectin 400 µg/kg
Intervention Description
Oral ivermectin 400 µg/kg three times (D0, D7 and D14) + topical treatment (permethrin 5% cream) on skin, hair and genital organs (D0 and D7) + emollient cream (Dexeryl® or other)daily on skin (D0 to D28)
Primary Outcome Measure Information:
Title
Rate of a successful treatment defined by : -Two negative parasitologic and/or two dermoscopic exams
Description
Parasitologic and/or dermoscopic exams will be perform at days 18 +/-2days and at days 21+/-2 days
Time Frame
Days 21+/-2 days
Title
Rate of a successful treatment defined by : - A clinical response : disappearance of clinical active lesions
Time Frame
Days 28+/- 2 days
Secondary Outcome Measure Information:
Title
Rate of adverse effects
Time Frame
Days 18 +/-2 days, Days 21+/-2 days and Days 28+/-2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients ≥ 18 years old, diagnosed with severe forms of scabies clinical criteria : cutaneous lesions of scabies crusted scabies: at least two sites of hyperkeratosis will define crusted scabies and/or profuse scabies : spreading lesions with erythematous scaly eruption of the neck, face or trunk without hyperkeratosis paraclinical criteria: Positive parasitological test and/or dermoscopic exam with signs of scabies Effective contraception for women in age of pregnancy Written consent from patient or his/her legal representant, trustworthy person or family member Affiliated to a social security scheme Exclusion Criteria: Pregnant and/or breastfeeding women Intolerance to ivermectin or topical treatment (permethrin 5% cream) or emollient cream Use of anti parasitic drug (ivermectin or albendazole) within the past 7 days Abnormal liver test results: ALT and/or AST >3N within the past 7 days (within 6 months if no hepatic history) Participation in other biomedical drug research Patient deprived of freedom Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giao DO-PHAM, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henri Mondor Hospital
City
Creteil
ZIP/Postal Code
94010
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/24069468
Description
Related Info
URL
http://www.cdc.gov/parasites/scabies/health_professionals/meds.html
Description
Related Info

Learn more about this trial

Efficacy Study Between Two Different Dosages of an Antiparasitic in Patients With Crusted Scabies

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