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CompletedNCT01019603Updated Jun 23, 2017

A Study to Evaluate the Bioavailability of Tazarotene Foam, 0.1%, and Tazorac Gel, 0.1%, in Subjects With Acne Vulgaris

A Phase 1 interventional study of Tazarotene and Tazaroc Gel in Acne Vulgaris, sponsored by Stiefel, a GSK Company. Completed at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2017-06-23.

Sponsored by Stiefel, a GSK Company · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

The purpose of this study is to assess systemic exposure of a new foam formulation of tazarotene, 0.1% compared with Tazorac Gel, 0.1%. The study design and dosing regimen are based on previous clinical studies with Tazorac Gel and Tazorac Cream.

Read the detailed description

A single-center, randomized, open-label, phase 1, comparative bioavailability study in subjects with moderate to severe acne vulgaris. Approximately 30 subjects will be enrolled and randomized to 1 of the 2 study product groups in a 1:1 ratio (tazarotene foam: Tazorac Gel). Study product will be applied once daily for 22 days to the face, upper chest, upper back, and shoulders. Following the baseline visit, subjects will return to the study center daily for study product application. Blood samples to determine plasma concentrations of tazarotenic acid will be collected before study product application on days 1, 8, 12, 15, 18, 20, and 22, and collected at multiple time points over a 72 hour period on days 22 through 25.

02

Conditions studied

  • Acne Vulgaris

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Keywords

  • Acne
03

In context

Acne Vulgaris

730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.

This study's enrollment of 30 is below the median of 69 across 628 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Stiefel, a GSK Company is the lead sponsor of 55 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female 12 years of age or older who is in good general health.
  • Have an Investigator's Static Global Assessment (ISGA) score of 3 or greater at baseline. The area considered for the ISGA must be confined to the face.
  • Regular menstrual cycle prior to study entry (as reported by the subject) for females of childbearing potential.
  • Negative urine pregnancy test for females of childbearing potential. • Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses.

Women who are not currently sexually active must agree to use medically accepted methods of contraception should they become sexually active while participating in the study. Male subjects and/or their partners must use a medically acceptable form of contraception.

  • Nonsmoker or smoker with at least 30 days abstinence from smoking or using nicotine-containing products prior to study entry and willing not to smoke or to use nicotine-containing products throughout the study.
  • Ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
  • Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed

Exclusion criteria

Exclusion Criteria:

  • Female who is pregnant, trying to become pregnant, or breast feeding.
  • History of known or suspected intolerance to any of the ingredients of the study products.
  • Use of topical antibiotics or topical corticosteroids for acne treatment within the past 2 weeks.
  • Use of systemic corticosteroids within the past 4 weeks.
  • Use of systemic retinoids (eg, isotretinoin) within the past 6 months.
  • Concurrent use of medications known to be photosensitizers because of the possibility of augmented photosensitivity.
  • Use of topical anti-acne medications (eg, benzoyl peroxide, retinoids) within the past 2 weeks.
  • Concomitant use of of facial products such as: abradants, facials, peels containing glycolic or other acids .
  • Facial procedure (eg, chemical or laser peel or microdermabrasion) performed by an esthetician, beautician, physician, nurse, or other practitioner within the past 2 weeks.
  • History or evidence of skin conditions other than acne (eg, eczema) that would interfere with the subject's participation in the study.
  • Consumption of alcohol within 24 hours prior to study product application on days 8, 12, 15, 18, 20, and 22 and within 72 hours post application on day 22.
  • Consumption of xanthine-containing beverages or products (eg, caffeinated coffee, tea, over-the counter medication for cold symptoms) within 24 hours prior to study product application on days 8, 12, 15, 18, 20, and 22 and within 72 hours post-application on day 22.
  • Anticipated need to engage in activities or exercise that would cause profuse sweating during the study.
  • Anticipated need for surgery or hospitalization during the study.
  • Require or desire excessive or prolonged exposure to ultraviolet light (eg, sunlight or tanning beds) during the study.
  • Concurrent involvement in another investigational study or participation within 30 days prior to the start of this study.
  • Any other condition that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
  • Currently lives in the same household as currently enrolled subjects; is an employee of Stiefel, an investigator, or a contract research organization involved in the study; or is an immediate family member (eg, partner, offspring, parents) of an employee involved in the study.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    1

    Tazarotene foam 0.1%

    Drug: Tazarotene

  • Active comparator
    2

    Tazaroc Gel 0.1%

    Drug: Tazaroc Gel

Interventions

  • DrugTazarotene

    Topical Tazarotene foam applied daily for 22 days.

    Also known as: Tazorac

  • DrugTazaroc Gel

    Topical tazarotene gel applied daily for 22 days.

    Also known as: Tazorac

06

What researchers measure

Primary outcomes

  1. Plasma concentrations of tazarotenic acid in subjects with acne vulgaris

    Time frame: Days 1, 8, 12, 15, 18, 20, 22 (pre-dose and 3, 4.5, 6, 7.5, 9, 12, 16, 20, 24, 38, 48, 62, and 72 hr post-dose

07

Study locations

1 site
  • DermResearch, Inc.
    Austin, Texas 78759, United States
08

References and documents

Publications

  • Jarratt M, Werner CP, Alio Saenz AB. Tazarotene foam versus tazarotene gel: a randomized relative bioavailability study in acne vulgaris. Clin Drug Investig. 2013 Apr;33(4):283-9. doi: 10.1007/s40261-013-0065-1. PubMed 23456673 ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01019603
Lead sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline
Responsible party
Sponsor
First posted
Nov 25, 2009
Start date
Oct 12, 2009
Primary completion
Dec 20, 2009
Completion
Dec 20, 2009
Last update
Jun 23, 2017

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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