NCT03664752

Brief Summary

study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel and IDP-120 Vehicle Gel

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
585

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2018

Geographic Reach
2 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

December 10, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2020

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

March 29, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

1.4 years

First QC Date

September 6, 2018

Results QC Date

March 3, 2023

Last Update Submit

March 3, 2023

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

  • Absolute Change in Mean Lesion Counts at Week 12

    For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.

    Baseline to Week 12

  • Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) and Had an EGSS at Week 12 That Equated to "Clear" or "Almost Clear"

    Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe.

    Baseline to Week 12

Secondary Outcomes (4)

  • Percentage Change in Mean Lesion Counts at Week 12

    Baseline to Week 12

  • Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS)

    Baseline to Week 12

  • Percentage Change in Mean Lesion Counts at Week 8

    Baseline to Week 8

  • Percentage Change in Mean Lesion Counts at Week 4

    Baseline to Week 4

Study Arms (2)

IDP-120 Gel

EXPERIMENTAL

IDP-120 Gel, once-daily application

Drug: IDP-120 Gel

IDP-120 vehicle gel

PLACEBO COMPARATOR

IDP-120 vehicle gel, once daily application

Drug: IDP-120 Vehicle Gel

Interventions

IDP-120 GelDRUG

IDP-120 Gel, once-daily application

IDP-120 Gel
IDP-120 Vehicle GelDRUG

IDP-120 Vehicle Gel, once-daily application

IDP-120 vehicle gel

Eligibility Criteria

Age9 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female at least 9 years of age and older;
  • Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit);
  • Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity Score (EGSS) assessment at the baseline visit;
  • Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50;
  • Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100;
  • Subjects with two or fewer facial nodules

You may not qualify if:

  • Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study;
  • Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis, eczema;
  • Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive;
  • Subjects with a facial beard or mustache that could interfere with the study assessments;
  • Subjects with more than two (2) facial nodules;
  • Evidence or history of cosmetic-related acne

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Valeant Site 210

Rogers, Arkansas, 72758, United States

Location

Valeant Site 201

Manhattan Beach, California, 90266, United States

Location

Valeant Site 206

San Diego, California, 92123, United States

Location

Valeant Site 218

San Diego, California, 92123, United States

Location

Valeant Site 204

Boynton Beach, Florida, 33437, United States

Location

Valeant Site 217

Brandon, Florida, 33511, United States

Location

Valeant Site 202S

Miami, Florida, 33144, United States

Location

Valeant Site 214

Tampa, Florida, 33606, United States

Location

Valeant Site 222

Snellville, Georgia, 30078, United States

Location

Valeant Site 215

Boise, Idaho, 83704, United States

Location

Valeant Site 205

Metairie, Louisiana, 70006, United States

Location

Valeant Site 216

Clarkston, Michigan, 48346, United States

Location

Valeant Site 221

Clinton Township, Michigan, 48038, United States

Location

Valeant Site 227

Rochester, New York, 14623, United States

Location

Valeant Site 229

Raleigh, North Carolina, 27612, United States

Location

Valeant Site 230

Raleigh, North Carolina, 27612, United States

Location

Valeant Site 213

San Antonio, Texas, 78213, United States

Location

Valeant Site 223

Spokane, Washington, 99202, United States

Location

Valeant Site 219

Waterloo, Ontario, N2J 1C4, Canada

Location

Valeant Site 228

Waterloo, Ontario, N2J 1C4, Canada

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Results Point of Contact

Title
Study Director
Organization
Bausch Health Americas, Inc
susan.harris@bauschhealth.com
19083009920

Study Officials

  • Anya Loncaric

    Bausch Health Companies

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) As a double-blinded study, the investigators, the site staff, the sponsor, and the clinical monitors will not be aware of the treatment assigned to the individual study subjects
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2018

First Posted

September 10, 2018

Study Start

December 10, 2018

Primary Completion

May 7, 2020

Study Completion

May 7, 2020

Last Updated

March 29, 2023

Results First Posted

March 29, 2023

Record last verified: 2023-03

Locations

US(18)CA(2)