Safety, Tolerability and Pharmacokinetics of AGN-190168 in Subjects With Acne Vulgaris

Acne Vulgaris Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02218034
• Other study ID #: 190168-069
• Status: Completed
• Phase: Phase 1
• First received: August 14, 2014
• Last updated: April 28, 2015
• Start date: August 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a safety, tolerability and pharmacokinetics study of AGN-190168 in subjects with acne vulgaris.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of acne vulgaris on the face

• No tobacco use for the past 30 days, and willing to refrain from nicotine use during the study

• Willing to avoid excessive or prolonged exposure of the treated skin to ultraviolet light (eg, sunlight, tanning beds) and extremes in weather, such as wind or cold, throughout the study

• If male, willing to maintain routine shaving regimen for the duration of the study and avoid shaving 12 hours prior to specified visits

• Females of childbearing potential must use a reliable method of contraception

Exclusion Criteria:

• Use of phototherapy devices (eg, ClearLight™) and adhesive cleansing strips (eg, Ponds® and Biore®), as well as cosmetic procedures (eg, facials, peeling, and comedone extraction) in the area to be treated in the past 1 week

• Use of topical anti-inflammatory drugs, salicylic acid (eg, Clearasil® and Clean & Clear®), corticosteroids, antibiotics, antibacterials (including benzoyl peroxide-containing products [eg, benzamycin]), retinoids, and other topical acne treatments (eg, photodynamic therapy, laser therapy, and medicated soaps) in the area to be treated in the past 2 weeks

• Ability to abstain from caffeine-containing products on the dates instructed

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• AGN-190168 Formulation 1
AGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
• AGN-190168 Formulation 2
AGN-190168 Formulation 2 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
• tazarotene gel 0.1%
Tazarotene gel 0.1% applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
• tazarotene cream 0.1%
Tazarotene cream 0.1% cream applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Level (Cmax) of AGN-190168		Day 29	No
Primary	Maximum Plasma Level (Cmax) of AGN-190168 Metabolite		Day 29	No
Primary	Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale		Day 29	No
Primary	Local Dermal Tolerability as Assessed by the Investigator Using a 4-Point Scale		Day 29	No