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Completed

NCT Number: NCT00469755

Differin® Gel x12 Wks vs Tazorac® Cream x12 Wks vs Differin® x6 Wks Switched to Tazorac® x6 Wks for Treatment of Acne

To determine the efficacy and safety of 12 weeks of treatment with Differin Gel, 0.1% compared to 12 weeks of treatment with Tazorac Cream, 0.1% and compared to 6 weeks treatment with Differin Gel, 0.1% followed by 6 weeks of treatment with Tazorac Cream

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Therapeutics Clinical Research, San Diego, California, United States

Loading trial locations.

About this study

Same as above.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face
  • Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose

Exclusion criteria

  • Subjects with more than 3 nodulo-cystic lesions

Treatment and study plan

Adapalene Gel, 0.1%

Drug

Apply once daily in the evening for 12 weeks

Other names: Differin® Gel, 0.1%

Tazarotene Cream, 0.1%

Drug

Apply once daily in the evening for 12 weeks

Other names: Tazorac® Cream, 0.1%

Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%

Drug

Apply adapalene Gel, 0.1% once daily in the evening for 6 weeks and Tazarotene Cream, 0.1% once daily in the evening for 6 weeks

Other names: Differin® Gel, 0.1% and Tazorac® Cream, 0.1%

Primary outcomes

  1. Efficacy - total lesion counts

    Time frame: 12 weeks

Secondary outcomes

  1. Safety - tolerability assessments and adverse event reporting

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A Comparison of Differin® Gel, 0.1% vs. Tazorac® Cream, 0.1% vs. Differin® Gel, 0.1% 6-week Treatment Switched to Tazorac® Cream, 0.1% 6-week Treatment in Patients With Acne Vulgaris

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
May 4, 2007
Registry last updated
Jul 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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