Not Yet RecruitingPhase 3Phase 4ACTRN12609000443291

Efficacy and Safety Comparison of two different topical gels (one active and one vehicle) in combination with an oral antibiotic in the treatment of Moderate to Severe Acne Vulgaris.

Efficacy and Safety Comparison of Adapalene 0.1%/Benzoyl Peroxide 2.5% gel associated with Lymecycline 300mg Capsules versus Adapalene 0.1%/Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules in the treatment of Moderate to Severe Acne Vulgaris.


Sponsor

Galderma Australia Pty Ltd

Enrollment

360 participants

Start Date

Aug 1, 2009

Study Type

Interventional

Conditions

Summary

In an attempt to further improve the management of moderate to severe acne, this study aims to investigate the efficacy and safety of a combination of a topical acne gel and an oral antibiotic.


Eligibility

Sex: Both males and femalesMin Age: 12 YearssMax Age: 35 Yearss

Inclusion Criteria2

  • Male or female Subjects of any race, between the age of 12
  • and 35 years inclusive, with moderate to severe acne

Exclusion Criteria4

  • Subjects with more than 3 nodules or cysts on the face
  • Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced
  • acne, etc.),
  • Female Subjects who are pregnant, nursing or planning a pregnancy during the study,

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Interventions

1g of Adapalene 0.1%/Benzoyl Peroxide 2.5% gel will be applied once daily in the evening to the entire face for 12 weeks. One Lymecycline 300mg Capsule will be taken orally in the morning with an ade

1g of Adapalene 0.1%/Benzoyl Peroxide 2.5% gel will be applied once daily in the evening to the entire face for 12 weeks. One Lymecycline 300mg Capsule will be taken orally in the morning with an adequate amount of fluid for 12 weeks.


Locations(1)

Australia

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ACTRN12609000443291


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