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Histopathology Following CCH Injection

NCT04236635 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-04-12

Study results available
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Summary

To evaluate the histopathology of subcutaneous tissue isolated after single or multiple Collagenase Clostridium Histolyticum (CCH) injection techniques in adult female participants undergoing abdominoplasty.

Conditions

  • Characteristics of Subcutaneous Tissue

Interventions

DRUG

Collagenase Clostridium Histolyticum Single Injection Technique

CCH was injected subcutaneously using a single injection technique. Dose per each administration was 0.07 mg.

DRUG

Collagenase Clostridium Histolyticum Multiple Injection Technique

CCH was injected subcutaneously using a multiple injection technique. Dose per each administration was 0.0653 mg.

Sponsors & Collaborators

  • Endo Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Karen Chajko · Endo Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-20
Primary Completion
2020-09-23
Completion
2020-10-26
FDA Drug
Yes

Countries

  • United States

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 NCT04236635 on ClinicalTrials.gov