Treatment of Pediculosis (Head Lice) in Senegal

NCT03578679 | Completed DMC

• 1 other identifier: SEN17/16
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective single-arm interventional study evaluating Therapeutic efficacy of a combination of two pharmaceutical drugs, Azithromycin (AZIT) and Ivermectin (IVER) administered orally in the treatment of head lice infestations. In case of persistence of lice and / or nits on day 7, a second oral administration of combination Azithromycin + Ivermectin will be considered. The duration of the study period is 4 months, ie 1 month and ½ of inclusion and 2 months and ½ feedback. There will be a site initiation visit "site initiation visit" before inclusions at D-7, two monitoring visits and a closing visit "close out visit" at the end of the follow-up at 4 months.

Conditions

Pediculoses

Outcome Measures

Primary Outcomes (1)

• Parasiticidal efficacy: disappearance of head lice (zero lice) on day 7

  Evaluating the efficacy of the treatment of combination of two usual drugs from volunteer subjects infested with head lice. To study the therapeutic efficacy of the combination Azithromycin-Ivermectin administered orally in the treatment of head lice infestations (in case of persistence of lice at D7 a second oral administration of the combination azithromycin-Ivermectin will be considered).

  Day 7

Study Arms (1)

HEGOR/AZICUR shampoo solution

EXPERIMENTAL

At D1, shampoo AZICUR liquid formulation in infested persons aged 0 to 6 years and / or less than 15 kg, also apply the combination HEGOR / AZICUR solution shampoo in women pregnant or lactating women not eligible for treatment with Ivermectin, to prevent them from contaminate treated participants who are very close to them or share the same bed or same bench table at school.

Drug: Ivermectin Oral Product

Interventions

Ivermectin Oral Product DRUG

treatment of pediculosis (head lice)

Also known as: Azithromycine oral Product

HEGOR/AZICUR shampoo solution

Eligibility Criteria

• Age: 6 Years+
• Gender Eligibility Details: Children, adolescents and adults infested with head lice and / or co-infestation head lice and body lice
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• body weight ≥ 15 kg for oral administration to ivermectin, • Obtain the signed informed consent of the parent or caregiver for his participation in the study.

You may not qualify if:

• Refusal of participation,
• Non-residents in the villages during the study period,
• body weight \<15 kg not eligible for oral administration with ivermectin,
• Pregnant women, who in the context of the daily medical and epidemiological monitoring of the population of Dielmo-like that of Ndiop- are identified and very early at the looking at the first signs of conception in a pregnant woman from her state of pregnancy on the basis of a proven test. In addition, before any treatment with ivermectin, will be systematically requested from each of the target women of reproductive age if she is pregnant
• Women breastfeeding at the time of the study,

Sponsors & Collaborators

• Institut de Recherche pour le Developpement: lead

Study Sites (1)

Institut de Recherche pour le Developpement

Dakar, 18524, Senegal

Location

MeSH Terms

Conditions

Lice Infestations

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Cheikh Sokhna, PhD

  Institut de Recherche pour le Developpement

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Evaluation of therapeutic efficacy of a combination of two usual drugs.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Interventional prospective study with only one arm

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 6, 2018
• Study Start: July 11, 2018
• Primary Completion: January 31, 2019
• Study Completion: February 24, 2019
• Last Updated: February 27, 2019

Record last verified: 2018-07

Locations

SE (1)