Acne Vulgaris
Conditions
Brief summary
Safety and Efficacy of IDP-123 Lotion (0.045% tazarotene) to Tazorac® (tazarotene) Cream, 0.1%, in the Treatment of Acne Vulgaris
Detailed description
A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Study to Compare the Safety and Efficacy of IDP-123 Lotion (0.045% tazarotene) to Tazorac® (tazarotene) Cream, 0.1%, in the Treatment of Acne Vulgaris
Interventions
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12 | Baseline (Day 0), 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. |
| Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12 | Baseline, 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. |
| Percentage of Participants With Treatment Success at Week 12 | Baseline, 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IDP-123 Lotion Lotion
IDP-123 Lotion: Lotion | 69 |
| Tazorac Cream Cream
Tazorac Cream: Cream | 72 |
| Vehicle Lotion Lotion
Vehicle Lotion: Lotion | 34 |
| Vehicle Cream Cream
Vehicle Cream: Cream | 35 |
| Total | 210 |
Baseline characteristics
| Characteristic | IDP-123 Lotion | Tazorac Cream | Vehicle Lotion | Vehicle Cream | Total |
|---|---|---|---|---|---|
| Age, Continuous | 23.3 years STANDARD_DEVIATION 10.2 | 22.0 years STANDARD_DEVIATION 8.96 | 21.2 years STANDARD_DEVIATION 9.27 | 21.2 years STANDARD_DEVIATION 7.96 | 22.2 years STANDARD_DEVIATION 9.23 |
| Sex: Female, Male Female | 37 Participants | 41 Participants | 17 Participants | 21 Participants | 116 Participants |
| Sex: Female, Male Male | 32 Participants | 31 Participants | 17 Participants | 14 Participants | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 68 | 4 / 71 | 1 / 34 | 2 / 33 |
| serious Total, serious adverse events | 0 / 68 | 0 / 71 | 0 / 34 | 0 / 33 |
Outcome results
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.
Time frame: Baseline, Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDP-123 Lotion | Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12 | -18.1 lesions | Standard Deviation 8.99 |
| Tazorac Cream | Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12 | -16.8 lesions | Standard Deviation 10.96 |
| Vehicle Lotion and Vehicle Cream Combined | Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12 | -14.0 lesions | Standard Deviation 8.64 |
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.
Time frame: Baseline (Day 0), Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDP-123 Lotion | Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12 | -21.6 lesions | Standard Deviation 13.98 |
| Tazorac Cream | Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12 | -20.3 lesions | Standard Deviation 13.67 |
| Vehicle Lotion and Vehicle Cream Combined | Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12 | -13.1 lesions | Standard Deviation 13.62 |
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.
Time frame: Baseline, Week 12
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IDP-123 Lotion | Percentage of Participants With Treatment Success at Week 12 | 13 Participants |
| Tazorac Cream | Percentage of Participants With Treatment Success at Week 12 | 12 Participants |
| Vehicle Lotion and Vehicle Cream Combined | Percentage of Participants With Treatment Success at Week 12 | 7 Participants |