Who is sponsoring NCT04170296?

NCT04170296 is sponsored by Endo Pharmaceuticals.

What drugs are being tested in NCT04170296?

Interventions in NCT04170296: EN3835.

What condition does NCT04170296 study?

NCT04170296 studies Edematous Fibrosclerotic Panniculopathy (EFP), Cellulite.

Is NCT04170296 still recruiting?

NCT04170296 is currently completed. Last updated 22 February 2022.

Are results published for NCT04170296?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-02-22 · How we verify

NCT04170296

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Real World CCH Study in Adult Females With Cellulite

Completed Phase 3 Results posted Last updated 22 February 2022

What this trial tests

Phase 3 trial testing EN3835 in Edematous Fibrosclerotic Panniculopathy (EFP) in 153 participants. Completed in 8 January 2021.

Timeline

1 November 2019

Primary endpoint
6 October 2020

8 January 2021

Quick facts

Lead sponsor	Endo Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	153
Start date	1 November 2019
Primary completion	6 October 2020
Estimated completion	8 January 2021
Sites	12 locations across Puerto Rico, United States

Drugs / interventions tested

EN3835 — full drug profile →

Conditions studied

Edematous Fibrosclerotic Panniculopathy (EFP) — all drugs for Edematous Fibrosclerotic Panniculopathy (EFP) →
Cellulite — all drugs for Cellulite →

Sponsor

Endo Pharmaceuticals — full company profile →

Who can join

Adults 18 to 60, female only, with Edematous Fibrosclerotic Panniculopathy (EFP) or Cellulite. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Posterolateral Thigh Primary · 90 Days

Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved".

Group	Value	95% CI
Cohort 1: Posterolateral Thigh	58

The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock Primary · 90 Days

Group	Value	95% CI
Cohort 2: Buttocks	58

Mean Change From Baseline in CR-PCSS for Each Buttock Secondary · Day 22, 43, 90 and 180

Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-point photonumeric scale rating cellulite severity from "0" (none) to "4" (severe) from a clinician's perspective.

Day 22

Group	Value	95% CI
Cohort 2: Buttocks (Left)	-0.3	± 0.52
Cohort 2: Buttocks (Right)	-0.3	± 0.50

Day 43

Group	Value	95% CI
Cohort 2: Buttocks (Left)	-0.6	± 0.63
Cohort 2: Buttocks (Right)	-0.5	± 0.59

Day 90

Group	Value	95% CI
Cohort 2: Buttocks (Left)	-0.7	± 0.70
Cohort 2: Buttocks (Right)	-0.7	± 0.53

Day 180

Group	Value	95% CI
Cohort 2: Buttocks (Left)	-0.7	± 0.63
Cohort 2: Buttocks (Right)	-0.6	± 0.63

Mean Change From Baseline in Body Q Appraisal of Cellulite for Posterolateral Thigh Based on Total Score Secondary · Day 90, Day 180

The Body-Q Appraisal of Cellulite is a subset of questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. The minimum possible score is 11 and the maximum possible score is 44. Higher scores indicate the individual is less bothered by their cellulite. Copyright Memorial Sloan-Kettering Cancer Center

Day 90

Group	Value	95% CI
Cohort 1: Posterolateral Thigh	10.9	± 9.84

Day 180

Group	Value	95% CI
Cohort 1: Posterolateral Thigh	10.9	± 9.76

Mean Change From Baseline in Body Q Appraisal of Cellulite for Buttock Based on Total Score Secondary · Day 90, Day 180

Day 90

Group	Value	95% CI
Cohort 2: Buttocks	8.8	± 8.38

Day 180

Group	Value	95% CI
Cohort 2: Buttocks	8.8	± 9.57

The Proportion of Participants With Improved (+1 or Better) Score on I GAIS for Either Posterolateral Thigh Secondary · Day 22, 43, and 180

Day 22

Group	Value	95% CI
Cohort 1: Posterolateral Thigh	64

Day 43

Group	Value	95% CI
Cohort 1: Posterolateral Thigh	59

Day 180

Group	Value	95% CI
Cohort 1: Posterolateral Thigh	61

The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock Secondary · Day 22, 43, and 180

Day 22

Group	Value	95% CI
Cohort 2: Buttocks	50

Day 43

Group	Value	95% CI
Cohort 2: Buttocks	62

Day 180

Group	Value	95% CI
Cohort 2: Buttocks	59

Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Posterolateral Thigh) Secondary · Day 1, 90, and 180

Immunogenicity samples with a positive titer value will undergo a log transformation for analyses. Samples with titer level less than 10 were assigned or imputed as a log transformed titer of 1 for analyses

Day 1

Group	Value	95% CI
Cohort 1: Posterolateral Thigh (Anti AUX-I)	5
Cohort 1: Posterolateral Thigh (Anti AUX-II)	5

Day 90

Group	Value	95% CI
Cohort 1: Posterolateral Thigh (Anti AUX-I)	60
Cohort 1: Posterolateral Thigh (Anti AUX-II)	60

Day 180

Group	Value	95% CI
Cohort 1: Posterolateral Thigh (Anti AUX-I)	68
Cohort 1: Posterolateral Thigh (Anti AUX-II)	68

Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Buttocks) Secondary · Day 1, 90 and 180

Day 1

Group	Value	95% CI
Cohort 2: Buttocks (Anti AUX-I)	7
Cohort 2: Buttocks (Anti AUX-II)	5

Day 90

Group	Value	95% CI
Cohort 2: Buttocks (Anti AUX-I)	61
Cohort 2: Buttocks (Anti AUX-II)	61

Day 180

Group	Value	95% CI
Cohort 2: Buttocks (Anti AUX-I)	66
Cohort 2: Buttocks (Anti AUX-II)	65

Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh) Secondary · Day 1, 90 and 180

All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb.

Day 1

Group	Value	95% CI
Cohort 1: Posterolateral Thigh (Anti AUX-I)	1
Cohort 1: Posterolateral Thigh (Anti AUX-II)	0
Cohort 1: Posterolateral Thigh (Anti AUX-I)	1
Cohort 1: Posterolateral Thigh (Anti AUX-II)	1

Day 90

Group	Value	95% CI
Cohort 1: Posterolateral Thigh (Anti AUX-I)	13
Cohort 1: Posterolateral Thigh (Anti AUX-II)	16
Cohort 1: Posterolateral Thigh (Anti AUX-I)	0
Cohort 1: Posterolateral Thigh (Anti AUX-II)	1

Day 180

Group	Value	95% CI
Cohort 1: Posterolateral Thigh (Anti AUX-I)	8
Cohort 1: Posterolateral Thigh (Anti AUX-II)	12
Cohort 1: Posterolateral Thigh (Anti AUX-I)	3
Cohort 1: Posterolateral Thigh (Anti AUX-II)	3

Presence of NAb Anti AUX-I and AUX-II (Buttocks) Secondary · Day 1, 90 and 180

Day 1

Group	Value	95% CI
Cohort 2: Buttocks (Anti AUX-I)	2
Cohort 2: Buttocks (Anti AUX-II)	2
Cohort 2: Buttocks (Anti AUX-I)	0
Cohort 2: Buttocks (Anti AUX-II)	0

Day 90

Group	Value	95% CI
Cohort 2: Buttocks (Anti AUX-I)	15
Cohort 2: Buttocks (Anti AUX-II)	9
Cohort 2: Buttocks (Anti AUX-I)	2
Cohort 2: Buttocks (Anti AUX-II)	4

Day 180

Group	Value	95% CI
Cohort 2: Buttocks (Anti AUX-I)	15
Cohort 2: Buttocks (Anti AUX-II)	9
Cohort 2: Buttocks (Anti AUX-I)	2
Cohort 2: Buttocks (Anti AUX-II)	4

Adverse events — posted to ClinicalTrials.gov

Time frame: Time of informed consent signature until Day 180. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1: Posterolateral Thigh

Serious: 0/81 (0%)

Deaths: 0/81

Cohort 2: Buttocks

Serious: 0/72 (0%)

Deaths: 0/72

Other adverse events (40 terms — click to expand)

Reaction	System	Cohort 1: Posterolateral T…	Cohort 2: Buttocks
Injection site bruising	General disorders	—	—
Injection site pain	General disorders	—	—
Injection site discolouration	General disorders	—	—
Injection site pruritus	General disorders	—	—
Injection site swelling	General disorders	—	—
Injection site oedema	General disorders	—	—
Injection site nodule	General disorders	—	—
Injection site mass	General disorders	—	—
Post-inflammatory pigmentation change	Skin and subcutaneous tissue disorders	—	—
Injection site haemorrhage	General disorders	—	—
Injection site reaction	General disorders	—	—
Nasopharyngitis	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Injection site dermatitis	General disorders	—	—
Injection site erythema	General disorders	—	—
Injection site rash	General disorders	—	—
Injection site warmth	General disorders	—	—
Pyrexia	General disorders	—	—
Drug hypersensitivity	Immune system disorders	—	—
Oral herpes	Infections and infestations	—	—
Sinusitis	Infections and infestations	—	—
Thermal burn	Injury, poisoning and procedural complications	—	—
Alanine aminotransferase increased	Investigations	—	—
Aspartate aminotransferase increased	Investigations	—	—
Blood potassium increased	Investigations	—	—
Blood sodium increased	Investigations	—	—
Blood urine present	Investigations	—	—
Coronavirus test positive	Investigations	—	—
Hepatic enzyme increased	Investigations	—	—
Nitrite urine present	Investigations	—	—
Urine ketone body present	Investigations	—	—
Urine leukocyte esterase positive	Investigations	—	—
White blood cell count increased	Investigations	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Dizziness	Nervous system disorders	—	—
Migraine	Nervous system disorders	—	—
Anxiety	Psychiatric disorders	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—
Diffuse alopecia	Skin and subcutaneous tissue disorders	—	—
Hypertension	Vascular disorders	—	—

Data from ClinicalTrials.gov NCT04170296 adverse events section.

Sponsor's own description

This is a multicenter, open-label, multiple dose, 2 cohort, Phase 3b study to assess the safety and efficacy of CCH in adult women with mild or moderate edematous fibrosclerotic panniculopathy (EFP). Cohort 1 will include approximately 80 subjects with mild or moderate EFP in the posterolateral thighs and Cohort 2 will include approximately 70 subjects with mild or moderate EFP in the buttocks.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Evaluation of five collagenase clostridium histolyticum-aaes injection techniques for the treatment of cellulite on the buttock or thigh.
Kaufman-Janette J, Katz BE, Vijayan S, Xiang Q, et al · · 2022 · cited 7× · PMID 35150194 · DOI 10.1111/jocd.14842

Verify or expand the search:

Other trials of EN3835

Trials testing the same drug.

NCT05254457 — Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis · Phase 3 · completed
NCT05152173 — Efficacy, Safety, and Tolerability, of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis · Phase 2 · completed
NCT04496167 — Safety and Efficacy of EN3835 in Participants With Frozen Shoulder · Phase 2 · completed
NCT04209530 — Impact of CCH Treatment of Buttock and Thigh Cellulite in Adult Women · Phase 2 · terminated
NCT03446781 — Effectiveness and Safety of EN3835 in the Treatment of Cellulite in Women · Phase 3 · completed

Other Endo Pharmaceuticals trials

Trials by the same sponsor.

NCT06169319 — A Study to Assess Collagenase Clostridium Histolyticum (CCH) in the Treatment of Plantar Fasciitis (PFA) · Phase 2 · completed
NCT05873595 — Real-World Data Study to Understand Effectiveness of Treatments in Peyronie's Disease · terminated
NCT05877066 — Real-World Data Study to Understand Participant Treatment Outcomes for Dupuytren's Contracture · terminated
NCT05419505 — Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks · Phase 2 · completed
NCT05254457 — Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04170296 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Endo Pharmaceuticals
Last refreshed: 22 February 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04170296.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04170296

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of EN3835

Other Endo Pharmaceuticals trials

Verify against primary sources