NCT02938494

Brief Summary

Safety and Efficacy of IDP-123 Lotion (0.045% tazarotene) to Tazorac® (tazarotene) Cream, 0.1%, in the Treatment of Acne Vulgaris

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

16 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

Study Start

First participant enrolled

November 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 11, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

September 23, 2020

Completed
Last Updated

September 23, 2020

Status Verified

September 1, 2020

Enrollment Period

8 months

First QC Date

October 11, 2016

Results QC Date

August 8, 2020

Last Update Submit

September 3, 2020

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (3)

  • Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12

    Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.

    Baseline (Day 0), Week 12

  • Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12

    Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.

    Baseline, Week 12

  • Percentage of Participants With Treatment Success at Week 12

    Treatment success was defined as at least a 2-grade reduction from Baseline in EGSS score and an EGSS score equating to "Clear" or "Almost Clear". EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.

    Baseline, Week 12

Study Arms (4)

IDP-123 Lotion

EXPERIMENTAL

Lotion

Drug: IDP-123 Lotion

Tazorac Cream

ACTIVE COMPARATOR

Cream

Drug: Tazorac Cream

Vehicle Lotion

ACTIVE COMPARATOR

Lotion

Drug: Vehicle Lotion

Vehicle Cream

ACTIVE COMPARATOR

Cream

Drug: Vehicle Cream

Interventions

IDP-123 LotionDRUG

Lotion

Also known as: Lotion
IDP-123 Lotion
Tazorac CreamDRUG

Cream

Also known as: Tazorac
Tazorac Cream
Vehicle LotionDRUG

Lotion

Also known as: Vehicle
Vehicle Lotion
Vehicle CreamDRUG

Cream

Also known as: Vehicle
Vehicle Cream

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female at least 12 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).
  • Women of childbearing potential and females that are pre-menses must be willing to practice effective contraception for the duration of the study. (Effective contraception is defined as stabilized on oral contraceptive for at least 3 months, IUD, condom with spermicidal, diaphragm with spermicidal, implant, Nuvaring, injection, transdermal patch or abstinence.) Females on birth control pills must have taken the same type pill for at least three months prior to entering the study and must not change type during the study. Those who have used birth control pills in the past must have discontinued usage at least three months prior to the start of the study. Women who use birth control for acne control only should be excluded.
  • Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the screening and baseline visits.

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, gramnegative 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.
  • Evidence or history of cosmetic-related acne.
  • Subject has a history of experiencing significant burning or stinging when applying any facial treatment (eg, make-up, soap, masks, washes, sunscreens, etc) to their face.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Valeant Site 03

Encinitas, California, 92024, United States

Location

Valeant Site 04

Fremont, California, 94538, United States

Location

Valeant Site 06

Los Angeles, California, 90036, United States

Location

Valeant Site 14

Sacramento, California, 95819, United States

Location

Valeant Site 01

Santa Monica, California, 90404, United States

Location

Valeant Site 05

Colorado Springs, Colorado, 80915, United States

Location

Valeant Site 08

Coral Gables, Florida, 33146, United States

Location

Valeant Site 10

Miami, Florida, 33175, United States

Location

Valeant Site 09

Miramar, Florida, 33027, United States

Location

Valeant Site 12

Louisville, Kentucky, 40202, United States

Location

Valeant Site 13

Louisville, Kentucky, 40217, United States

Location

Valeant Site 02

Rockville, Maryland, 20850, United States

Location

Valeant Site 07

Fridley, Minnesota, 55432, United States

Location

Valeant Site 16

Chapel Hill, North Carolina, 27517, United States

Location

Valeant Site 15

High Point, North Carolina, 27262, United States

Location

Valeant Site 11

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

tazarotene

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Results Point of Contact

Title
Study Director
Organization
Bausch Health
anya.loncaric@bauschhealth.com

Study Officials

  • Anya Loncaric

    Valeant Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2016

First Posted

October 19, 2016

Study Start

November 1, 2015

Primary Completion

July 1, 2016

Study Completion

September 1, 2016

Last Updated

September 23, 2020

Results First Posted

September 23, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

Locations

US(16)