Durability and Safety of CCH With Two Different Injection Techniques in Cellulite With Laxity

NCT ID: NCT05249257

Last Updated: 2023-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-25

Study Completion Date

2022-09-12

Brief Summary

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All participants who completed the EN3835-224 study will be invited to participate in this observational study to evaluate long term durability of response and safety.

Detailed Description

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Conditions

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Cellulite Laxity; Skin Edematous Fibrosclerotic Panniculopathy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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No Treatment - previously treated in parent study

Participants who completed the parent study EN3835-224 (NCT04580303) will be eligible for this study.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Have participated in and completed study EN3835-224 (parent study).
2. Be willing and able to cooperate with the requirements of the study.

Exclusion Criteria

1. Has received any collagenase treatments (eg, Santyl® Ointment) at any time since
2. Has had any surgery, invasive procedure (eg, liposuction), injectable treatment (eg, KYBELLA®) or any similar treatment in the area treated during the EN3835-224 study since the completion of that study.
3. Has any other conditions that, in the investigator's opinion, might indicate the participant to be unsuitable for the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Endo Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen Chajko

Role: STUDY_DIRECTOR

Endo Pharmaceuticals

Locations

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Endo Clinical Trial Site #2

Coral Gables, Florida, United States

Site Status

Endo Clinical Trial Site #3

Metairie, Louisiana, United States

Site Status

Endo Clinical Trial Site #1

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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EN3835-225

Identifier Type: -

Identifier Source: org_study_id

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