NCT00829049

Brief Summary

Comparison of the safety and efficacy of Tazarotene Cream 0.1% compared with Adapalene Gel 0.3% in treating moderate to severe facial acne vulgaris

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
165

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 26, 2009

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

September 12, 2012

Completed
Last Updated

September 12, 2012

Status Verified

August 1, 2012

Enrollment Period

1 year

First QC Date

January 22, 2009

Results QC Date

September 22, 2011

Last Update Submit

August 20, 2012

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

  • Median Percent Change From Baseline in the Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12

    Median percent change from baseline in the non-inflammatory lesion counts (open and closed comedones) at Week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts(improvement).

    Baseline, Week 12

Secondary Outcomes (3)

  • Percentage of Patients With >= 1 Grade Improvement in the Investigator Global Assessment at Week 16

    Week 16

  • Percentage of Patients With >= 2 Grade Improvement in the Overall Disease Severity Score at Week 12

    Week 12

  • Median Percent Change From Baseline in Inflammatory Lesion Counts (Papules/Pustules, Nodules) at Week 16

    Baseline, Week 16

Study Arms (2)

Tazarotene Cream 0.1%

ACTIVE COMPARATOR

1 pea-size amount, QD x 16 weeks

Drug: Tazarotene Cream 0.1%

Adapalene Gel 0.3%

ACTIVE COMPARATOR

1 pea-size amount, QD x 16 weeks

Drug: Adapalene

Interventions

Tazarotene Cream 0.1%DRUG

1 pea-size amount, QD x 16 weeks

Also known as: TAZORAC® Cream 0.1%
Tazarotene Cream 0.1%
AdapaleneDRUG

1 pea-size amount, QD x 16 weeks

Also known as: Differin® Gel 0.3%
Adapalene Gel 0.3%

Eligibility Criteria

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

You may qualify if:

  • Facial acne vulgaris characterized by the following: 25-100 facial inflammatory lesions (papules plus pustules); and 40 or more non-inflammatory lesions (open/closed comedones)); stable disease, non-rapidly regressing facial acne vulgaris; and, 3 or less facial nodules and/or cysts (diameter of 1cm or greater).
  • Female subjects of childbearing potential must have a negative urine pregnancy test at baseline and practice reliable method of contraception throughout the study.

You may not qualify if:

  • Non-compliance with washout period
  • Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris
  • Allergy or sensitivity to any component of the test medications
  • Cosmetic or surgical procedure complementary to the treatment of facial acne within 14 days of the baseline visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Fremont, California, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Adapalene

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Limitations and Caveats

Study enrollment was terminated due to company decision before the target enrollment of 220 patients was reached.

Results Point of Contact

Title
Vice President, Medical Affairs
Organization
Allergan, Inc.
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2009

First Posted

January 26, 2009

Study Start

October 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

September 12, 2012

Results First Posted

September 12, 2012

Record last verified: 2012-08

Locations

US(1)