Safety and Efficacy of IDP-123 Lotion to Tazorac® Cream,... | NCT02938494

Status Module

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
IDP-123 Lotion	Drug	Lotion	IDP-123 Lotion	Lotion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

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.

Key Exclusion Criteria:

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.

Name	Affiliation	Role
Anya Loncaric	Valeant Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Valeant Site 03		Encinitas	California	92024	United States
Valeant Site 04

Results Section

Participant Flow Module

ID	Title	Description
FG000	IDP-123 Lotion	Lotion IDP-123 Lotion: Lotion
FG001	Tazorac Cream	Cream Tazorac Cream: Cream

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	IDP-123 Lotion	Lotion IDP-123 Lotion: Lotion
BG001	Tazorac Cream	Cream Tazorac Cream: Cream
BG002	Vehicle Lotion	Lotion Vehicle Lotion: Lotion
BG003	Vehicle Cream	Cream Vehicle Cream: Cream
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00069 BG00172 BG00234 BG00335 BG004210

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Efficacy analyses compared IDP-123 Lotion and the combined Vehicle Lotion and Vehicle Cream groups, as pre-specified in the statistical analysis plan. There is no information for separate Vehicle Lotion and Vehicle Cream groups, since the comparator group was pre-specified to be combined Vehicle Lotion and Vehicle Cream.

Posted

Mean

Standard Deviation

lesions

Baseline (Day 0), Week 12

ID	Title	Description
OG000	IDP-123 Lotion	0.045% tazarotene
OG001	Tazorac Cream	Tazorac Cream 0.1%
OG002	Vehicle Lotion and Vehicle Cream Combined	Vehicle Lotion and Vehicle Cream Combined

Units	Counts
Participants	OG00069 OG00172 OG00269

Title

Denominators

Categories

Title	Measurements
	OG000-21.6± 13.98 OG001-20.3± 13.67 OG002-13.1± 13.62

Primary

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.

Posted

Mean

Standard Deviation

lesions

Baseline, Week 12

ID	Title	Description
OG000	IDP-123 Lotion	0.045% tazarotene
OG001	Tazorac Cream	Tazorac Cream 0.1%
OG002	Vehicle Lotion and Vehicle Cream Combined	Vehicle Lotion and Vehicle Cream Combined

Primary

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.

Posted

Count of Participants

Participants

Baseline, Week 12

ID	Title	Description
OG000	IDP-123 Lotion	0.045% tazarotene
OG001	Tazorac Cream	Tazorac Cream 0.1%
OG002	Vehicle Lotion and Vehicle Cream Combined	Vehicle Lotion and Vehicle Cream Combined

Units	Counts

Arm/Groups

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	IDP-123 Lotion	Lotion IDP-123 Lotion: Lotion	68	2	68
EG001	Tazorac Cream	Cream Tazorac Cream: Cream	71	4	71
EG002	Vehicle Lotion	Lotion Vehicle Lotion: Lotion	34	1	34
EG003	Vehicle Cream	Cream Vehicle Cream: Cream	33	2	33

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases