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.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000443291

Enrollment

360

Registered

2009-06-12

Start date

2009-08-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 adequate amount of fluid for 12 weeks.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

12 Years to 35 Years

Healthy volunteers

Inclusion criteria

Male or female Subjects of any race, between the age of 12 and 35 years inclusive, with moderate to severe acne vulgaris, meeting specific inclusion/exclusion criteria.

Exclusion criteria

Subjects with more than 3 nodules or cysts on the face 2. Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), 3. Female Subjects who are pregnant, nursing or planning a pregnancy during the study,

Outcome results