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EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)

Primary Purpose

Edematous Fibrosclerotic Panniculopathy, Cellulite

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Collagenase Clostridium Histolyticum

Sponsored by

Endo Pharmaceuticals

About this trial

This is an interventional treatment trial for Edematous Fibrosclerotic Panniculopathy

Eligibility Criteria

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

Inclusion Criteria for Observation Phase:

Voluntarily sign and date an informed consent agreement
Have participated in and completed the double-blind study EN3835-201
Be willing to apply sunscreen to any treated quadrant before each exposure to sun

Inclusion Criteria for Treatment Phase:

Voluntarily sign and date an informed consent agreement
Have participated in and completed the double-blind study EN3835-201
Be willing to apply sunscreen to any treated quadrant before each exposure to sun
Have at least 1 quadrant with: a score of 3 or 4 (moderate or severe) as reported on the PCSS (Photonumeric Cellulite Severity Scale) by the subject or investigator, and a Hexsel CSS (Cellulite Severity Scale) score no greater than 13
Be judged to be in good health
Have a negative urine pregnancy test at screening and be using an effective contraception method, be surgically sterile, or post-menopausal

Exclusion Criteria for Observation Phase:

None

Exclusion Criteria for Treatment Phase:

Has used, or intends to use during the course of the study, other treatment of EFP on the legs or buttocks
Is presently nursing a baby or providing breast milk for a baby
Intends to become pregnant during the study
Currently receiving, has received within 7 days before injection of study drug, or plans to receive an anticoagulant or antiplatelet medication
History of stroke or bleeding

Sites / Locations

Endo Clinical Trial Site #1
Endo Clinical Trial Site #2
Endo Clinical Trial Site #3
Endo Clinical Trial Site #4
Endo Clinical Trial Site #5
Endo Clinical Trial Site #6
Endo Clinical Trial Site #7
Endo Clinical Trial Site #8
Endo Clinical Trial Site #10
Endo Clinical Trial Site #9
Endo Clinical Trial Site #11
Endo Clinical Trial Site #12
Endo Clinical Trial Site #13
Endo Clinical Trial Site #14
Endo Clinical Trial Site #15

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EN3835 Active

Arm Description

EN3835 0.84mg (Collagenase Clostridium Histolyticum)

Outcomes

Primary Outcome Measures

Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase

Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 2-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 2-levels from baseline on both the CR-PCSS and the PR-PCSS at a particular visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202. Three participants were discontinued from the study after Day 180, percentages are based on the observed counts.

Secondary Outcome Measures

Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase

Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 1-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 1-level from baseline on both the PR-PCSS and the CR-PCSS at a particular visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202.

Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase

Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 2-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 2-levels from baseline on both the CR-PCSS and the PR-PCSS at a particular visit. Long-term Durability Phase is defined as all participants in the Overall Durability Population who showed an improvement on Day 71 of at least 1-level on each scale (CR-PCSS and PR-PCSS) from baseline for the treatment area treated with EN3835 in the double-blind Study (EN3835-201).

Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase

Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 1-level composite responder is a participant who received EN3835 with a reduction (decrease in score) in severity of at least 1-level from baseline on both the PR-PCSS and the CR-PCSS at a particular visit. Long-term Durability Phase is defined as all participants in the Overall Durability Population who showed an improvement on Day 71 of at least 1-level on each scale (CR-PCSS and PR-PCSS) from baseline for the treatment area treated with EN3835 in the double-blind Study (EN3835-201).

CR-PCSS Change From Baseline (in EN3835-201 Study) by Visit During the Observation Phase

Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A negative change from baseline indicates an improvement in cellulite severity. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202.

CR-PCSS Change From Baseline (BL) by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment

Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A decrease in the CR-PCSS score from baseline indicates an improvement in cellulite severity. Treatment phase is defined as the time period from the second EN3835 treatment date to the end of Study EN3835-202. One hundred sixty-two participants received a second treatment course Study EN3835-202 and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202.

PR-PCSS Change From Baseline by Visit in Treatment Phase for Participants With Second EN3835 Treatment

Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A decrease in the PR-PCSS score from baseline indicates an improvement in cellulite severity. Treatment phase is defined as the time period from the second EN3835 treatment date to the end of Study EN3835-202. One hundred sixty-two participants received a second treatment course in this study and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202.

Change From Baseline on the Hexsel CSS Total Score During the Observation Phase

The Hexsel Cellulite Severity Scale (CSS) is a photonumeric scale that evaluates 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature. Each of these features is evaluated on a 4-point scale from a low of "0" to a high of "3", with higher scores signifying more severe cellulite. The Hexcel CSS total score is the sum of all 5 features and can range from "0" (no cellulite) to "15" (extremely severe cellulite) and is designated in this study as the Hexsel CSS total score.

Change From Baseline (BL) in the Hexsel CSS Total Score During Long-term Durability Visits

The Hexsel Cellulite Severity Scale (CSS) is a photonumeric scale that evaluates 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature. Each of these features is evaluated on a 4-point scale from a low of "0" to a high of "3", with higher scores indicating more severe cellulite. The total score is a summation of all 5 features and can range from "0" (no cellulite) to "15" (extremely severe cellulite) and is designated in this study as the Hexsel CSS total score. A negative change from baseline indicates an improvement in cellulite severity.

Change From Baseline in Hexsel CSS Total Score in Treatment Phase for Participants With Second EN3835 Treatment

The Hexsel Cellulite Severity Scale (CSS) is a photonumeric scale that evaluates 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature. Each of these features is evaluated on a 4-point scale from a low of "0" to a high of "3". The total score is a summation of all 5 features and can range from "0" (no cellulite) to "15" (extremely severe cellulite) and is designated in this study as the Hexsel CSS total score. Change from baseline is the visit total score minus baseline total score. A negative change from baseline indicates an improvement in cellulite severity. Treatment phase is defined as the time period from the second EN3835 treatment date to the end of Study EN3835-202.

Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase

Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from "+3" (Very much improved) to "-3" (Very much worse), an increase in the I-GAIS scores indicates an improvement in Global Aesthetic Score. Percentages are based on the number of all evaluable subjects at each visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202.

Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment

Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from "+3" (Very much improved) to "-3" (Very much worse), an increase in the I-GAIS indicates an improvement in global aesthetics. Percentages are based on the number of all evaluable participants at each visit. One hundred sixty-two participants received a second treatment course in this study and were included in the Effectiveness Population. This retreated/dosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment course in Study EN3835-202.

Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360

Subject Global Aesthetic Improvement Scale (S-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from "+3" (Very much improved) to "-3" (Very much worse), an increase in S-GAIS indicates an improvement. Percentages are based on the number of all evaluable participants at each visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202.

Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment

Subject Global Aesthetic Improvement Scale (S-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from "+3" (Very much improved) to "-3" (Very much worse). Percentages are based on the number of evaluable participants at each visit. One hundred sixty-two participants received a second treatment course in EN3835-202 Study and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202. Treatment phase is defined as the time period from the second EN3835 treatment date to the End of Study EN3835-202.

Subject Satisfaction With EFP Treatment at the End of Study (EOS) in Observation Phase, Observation Visit Day 360

Subject Satisfaction with Cellulite Treatment Scale is a 5-level scale designed for participants to assess their satisfaction with cellulite treatment. The scale ranges from "+2" (I am very satisfied with the cellulite treatment on my buttocks or thighs) to "-2" (I am very dissatisfied with the cellulite treatment on my buttocks or thighs). Percentages are based on the number of evaluable participants at each visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202. (EFP = Edematous Fibrosclerotic Panniculopathy, aka Cellulite)

Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment

Subject Satisfaction with Cellulite Treatment Scale is a 5-level scale designed for participants to assess their satisfaction with cellulite treatment. The scale ranges from "+2" (I am very satisfied with the cellulite treatment on my buttocks or thighs) to "-2" (I am very dissatisfied with the cellulite treatment on my buttocks or thighs). Percentages are based on the number of evaluable participants at each visit. One hundred sixty-two participants received a second treatment course in Study EN3835-202 and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202. Treatment phase is defined as the time period from the second EN3835 treatment date to the End of Study EN3835-202.

Full Information

NCT ID

First Posted

October 20, 2016

Last Updated

November 2, 2020

Sponsor

Endo Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02942160

Brief Title

EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)

Official Title

A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

October 5, 2016 (Actual)

Primary Completion Date

June 14, 2018 (Actual)

Study Completion Date

June 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Endo Pharmaceuticals

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy (commonly known as Cellulite).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Edematous Fibrosclerotic Panniculopathy, Cellulite

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

259 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EN3835 Active

Arm Type

Experimental

Arm Description

EN3835 0.84mg (Collagenase Clostridium Histolyticum)

Intervention Type

Biological

Intervention Name(s)

Collagenase Clostridium Histolyticum

Other Intervention Name(s)

Xiaflex

Primary Outcome Measure Information:

Title

Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase

Description

Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 2-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 2-levels from baseline on both the CR-PCSS and the PR-PCSS at a particular visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202. Three participants were discontinued from the study after Day 180, percentages are based on the observed counts.

Time Frame

Day 180 to Day 360

Secondary Outcome Measure Information:

Title

Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase

Description

Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 1-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 1-level from baseline on both the PR-PCSS and the CR-PCSS at a particular visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202.

Time Frame

Day 180 to Day 360

Title

Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase

Description

Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 2-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 2-levels from baseline on both the CR-PCSS and the PR-PCSS at a particular visit. Long-term Durability Phase is defined as all participants in the Overall Durability Population who showed an improvement on Day 71 of at least 1-level on each scale (CR-PCSS and PR-PCSS) from baseline for the treatment area treated with EN3835 in the double-blind Study (EN3835-201).

Time Frame

Day 540 to Day 720

Title

Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase

Description

Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 1-level composite responder is a participant who received EN3835 with a reduction (decrease in score) in severity of at least 1-level from baseline on both the PR-PCSS and the CR-PCSS at a particular visit. Long-term Durability Phase is defined as all participants in the Overall Durability Population who showed an improvement on Day 71 of at least 1-level on each scale (CR-PCSS and PR-PCSS) from baseline for the treatment area treated with EN3835 in the double-blind Study (EN3835-201).

Time Frame

Day 540 to Day 720

Title

CR-PCSS Change From Baseline (in EN3835-201 Study) by Visit During the Observation Phase

Description

Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A negative change from baseline indicates an improvement in cellulite severity. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202.

Time Frame

Baseline (in EN3835-201 Study) to Observation Day 360

Title

CR-PCSS Change From Baseline (BL) by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment

Description

Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A decrease in the CR-PCSS score from baseline indicates an improvement in cellulite severity. Treatment phase is defined as the time period from the second EN3835 treatment date to the end of Study EN3835-202. One hundred sixty-two participants received a second treatment course Study EN3835-202 and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202.

Time Frame

Day 22 to Day 360

Title

PR-PCSS Change From Baseline by Visit in Treatment Phase for Participants With Second EN3835 Treatment

Description

Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A decrease in the PR-PCSS score from baseline indicates an improvement in cellulite severity. Treatment phase is defined as the time period from the second EN3835 treatment date to the end of Study EN3835-202. One hundred sixty-two participants received a second treatment course in this study and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202.

Time Frame

Day 22 to Day 360

Title

Change From Baseline on the Hexsel CSS Total Score During the Observation Phase

Description

The Hexsel Cellulite Severity Scale (CSS) is a photonumeric scale that evaluates 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature. Each of these features is evaluated on a 4-point scale from a low of "0" to a high of "3", with higher scores signifying more severe cellulite. The Hexcel CSS total score is the sum of all 5 features and can range from "0" (no cellulite) to "15" (extremely severe cellulite) and is designated in this study as the Hexsel CSS total score.

Time Frame

Baseline (in EN3835-201 Study) to Day 360

Title

Change From Baseline (BL) in the Hexsel CSS Total Score During Long-term Durability Visits

Description

The Hexsel Cellulite Severity Scale (CSS) is a photonumeric scale that evaluates 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature. Each of these features is evaluated on a 4-point scale from a low of "0" to a high of "3", with higher scores indicating more severe cellulite. The total score is a summation of all 5 features and can range from "0" (no cellulite) to "15" (extremely severe cellulite) and is designated in this study as the Hexsel CSS total score. A negative change from baseline indicates an improvement in cellulite severity.

Time Frame

Day 540 to Day 720

Title

Change From Baseline in Hexsel CSS Total Score in Treatment Phase for Participants With Second EN3835 Treatment

Description

The Hexsel Cellulite Severity Scale (CSS) is a photonumeric scale that evaluates 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature. Each of these features is evaluated on a 4-point scale from a low of "0" to a high of "3". The total score is a summation of all 5 features and can range from "0" (no cellulite) to "15" (extremely severe cellulite) and is designated in this study as the Hexsel CSS total score. Change from baseline is the visit total score minus baseline total score. A negative change from baseline indicates an improvement in cellulite severity. Treatment phase is defined as the time period from the second EN3835 treatment date to the end of Study EN3835-202.

Time Frame

Baseline - Day 360

Title

Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase

Description

Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from "+3" (Very much improved) to "-3" (Very much worse), an increase in the I-GAIS scores indicates an improvement in Global Aesthetic Score. Percentages are based on the number of all evaluable subjects at each visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202.

Time Frame

Day 360

Title

Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment

Description

Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from "+3" (Very much improved) to "-3" (Very much worse), an increase in the I-GAIS indicates an improvement in global aesthetics. Percentages are based on the number of all evaluable participants at each visit. One hundred sixty-two participants received a second treatment course in this study and were included in the Effectiveness Population. This retreated/dosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment course in Study EN3835-202.

Time Frame

Day 71 - Day 360

Title

Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360

Description

Subject Global Aesthetic Improvement Scale (S-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from "+3" (Very much improved) to "-3" (Very much worse), an increase in S-GAIS indicates an improvement. Percentages are based on the number of all evaluable participants at each visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202.

Time Frame

Day 360

Title

Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment

Description

Subject Global Aesthetic Improvement Scale (S-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from "+3" (Very much improved) to "-3" (Very much worse). Percentages are based on the number of evaluable participants at each visit. One hundred sixty-two participants received a second treatment course in EN3835-202 Study and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202. Treatment phase is defined as the time period from the second EN3835 treatment date to the End of Study EN3835-202.

Time Frame

Day 71 - Day 360

Title

Subject Satisfaction With EFP Treatment at the End of Study (EOS) in Observation Phase, Observation Visit Day 360

Description

Subject Satisfaction with Cellulite Treatment Scale is a 5-level scale designed for participants to assess their satisfaction with cellulite treatment. The scale ranges from "+2" (I am very satisfied with the cellulite treatment on my buttocks or thighs) to "-2" (I am very dissatisfied with the cellulite treatment on my buttocks or thighs). Percentages are based on the number of evaluable participants at each visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202. (EFP = Edematous Fibrosclerotic Panniculopathy, aka Cellulite)

Time Frame

Day 360

Title

Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment

Description

Subject Satisfaction with Cellulite Treatment Scale is a 5-level scale designed for participants to assess their satisfaction with cellulite treatment. The scale ranges from "+2" (I am very satisfied with the cellulite treatment on my buttocks or thighs) to "-2" (I am very dissatisfied with the cellulite treatment on my buttocks or thighs). Percentages are based on the number of evaluable participants at each visit. One hundred sixty-two participants received a second treatment course in Study EN3835-202 and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202. Treatment phase is defined as the time period from the second EN3835 treatment date to the End of Study EN3835-202.

Time Frame

Day 71 - Day 360

Other Pre-specified Outcome Measures:

Title

Overall Serum Antibody at Observation Visit Day 360

Description

Percent of participants that are seropositive. Descriptive statistics are based on log10 transformation of titer levels. Percent is based on the number of subjects who had immunogenicity lab samples drawn at the visit

Time Frame

Day 360

Title

Overall Antibody Log Titer Levels at Observation Visit Day 360

Description

Descriptive statistics are based on log10 transformation of titer levels.

Time Frame

Day 360

Title

Neutralizing Antibodies at Observation Visit Day 360

Description

Participants with binding antibodies were tested for neutralizing antibodies.

Time Frame

Day 360

Title

Overall Antibody Log Titer Levels by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment

Description

Descriptive statistics are based on Seropositive participants. Descriptive statistics are based on log10 transformation of titer levels.

Time Frame

Day 1 to Day 360

Title

Neutralizing Antibodies in Treatment Phase for Participants With a Second EN3835 Treatment

Description

Tx Obs = Treatment Observation

Time Frame

Day 71 to Day 360

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria for Observation Phase: Voluntarily sign and date an informed consent agreement Have participated in and completed the double-blind study EN3835-201 Be willing to apply sunscreen to any treated quadrant before each exposure to sun Inclusion Criteria for Treatment Phase: Voluntarily sign and date an informed consent agreement Have participated in and completed the double-blind study EN3835-201 Be willing to apply sunscreen to any treated quadrant before each exposure to sun Have at least 1 quadrant with: a score of 3 or 4 (moderate or severe) as reported on the PCSS (Photonumeric Cellulite Severity Scale) by the subject or investigator, and a Hexsel CSS (Cellulite Severity Scale) score no greater than 13 Be judged to be in good health Have a negative urine pregnancy test at screening and be using an effective contraception method, be surgically sterile, or post-menopausal Exclusion Criteria for Observation Phase: None Exclusion Criteria for Treatment Phase: Has used, or intends to use during the course of the study, other treatment of EFP on the legs or buttocks Is presently nursing a baby or providing breast milk for a baby Intends to become pregnant during the study Currently receiving, has received within 7 days before injection of study drug, or plans to receive an anticoagulant or antiplatelet medication History of stroke or bleeding

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mike McLane

Organizational Affiliation

Endo Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Endo Clinical Trial Site #1

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90210

Country

United States

Facility Name

Endo Clinical Trial Site #2

City

Murrieta

State/Province

California

ZIP/Postal Code

92562

Country

United States

Facility Name

Endo Clinical Trial Site #3

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

Facility Name

Endo Clinical Trial Site #4

City

San Diego

State/Province

California

ZIP/Postal Code

92121

Country

United States

Facility Name

Endo Clinical Trial Site #5

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

Endo Clinical Trial Site #6

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33146

Country

United States

Facility Name

Endo Clinical Trial Site #7

City

Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

Endo Clinical Trial Site #8

City

Washington

State/Province

Missouri

ZIP/Postal Code

63091

Country

United States

Facility Name

Endo Clinical Trial Site #10

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Endo Clinical Trial Site #9

City

New York

State/Province

New York

ZIP/Postal Code

10075

Country

United States

Facility Name

Endo Clinical Trial Site #11

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37215

Country

United States

Facility Name

Endo Clinical Trial Site #12

City

Pflugerville

State/Province

Texas

ZIP/Postal Code

78660

Country

United States

Facility Name

Endo Clinical Trial Site #13

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22911

Country

United States

Facility Name

Endo Clinical Trial Site #14

City

Lynchburg

State/Province

Virginia

ZIP/Postal Code

24501

Country

United States

Facility Name

Endo Clinical Trial Site #15

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

12. IPD Sharing Statement

Learn more about this trial

EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)

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