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Bioequivalence Study of Ivermectin 1% Cream and Soolantra (Ivermectin) 10 mg/g Cream

NCT06557603 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-08-20

No results posted yet for this study

Summary

Single dose bioequivalence study of Ivermectin 1% cream and Soolantra (Ivermectin) 10 mg/g cream in healthy adult human subjects.

Conditions

  • Rosacea

Interventions

DRUG

Ivermectin cream

\[1 gm ± 0.030 gm\] of product was applied in a thin layer over the entire face (avoiding the eyes, lips, and mucous membranes).

DRUG

Soolantra ® (Ivermectin) cream

\[1 gm ± 0.030 gm\] of product was applied in a thin layer over the entire face (avoiding the eyes, lips, and mucous membranes).

Sponsors & Collaborators

  • Humanis Saglık Anonim Sirketi

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-06
Primary Completion
2024-07-11
Completion
2024-07-22

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06557603 on ClinicalTrials.gov