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

Galderma

Status and phase: Completed; Phase 4

Conditions: Acne Vulgaris

Treatments: Drug: Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%; Drug: Adapalene Gel, 0.1%; Drug: Tazarotene Cream, 0.1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00469755

US10026

Details and patient eligibility

About

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

Full description

Same as above.

Enrollment: 302 patients

Sex: All

Ages: 12 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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302 participants in 3 patient groups

1

Active Comparator group

Description:

Differin® Gel, 0.1% for 12 weeks

Treatment:

Drug: Adapalene Gel, 0.1%

2

Active Comparator group

Description:

Tazorac® Cream, 0.1% for 12 weeks

Treatment:

Drug: Tazarotene Cream, 0.1%

3

Active Comparator group

Description:

Differin® Gel, 0.1% for 6 weeks switched to Tazorac® Cream, 0.1% for 6 weeks

Treatment:

Drug: Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%