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NCT Number: NCT00635609

Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate

Randomized, multi-center, open label, active-comparator study to compare the efficacy and tolerability of Doryx Delayed Release Tablets to doxycycline hyclate in patients with moderate to severe acne vulgaris.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Warner Chilcott Investigational Site, Vista, California, United States

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About this study

Efficacy of Doryx Delayed Release Tablets to doxycycline hyclate will be assessed using an Investigator's Global Assessment (IGA) score and the absolute change from baseline to 12 weeks in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline to 12 weeks in non-inflammatory lesions count of Doryx Delayed Release Tablets compared to doxycycline hyclate will be evaluated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must be 12 years of age or older.
  • Has a diagnosis of facial acne vulgaris with no more than two nodules on the face.

Exclusion criteria

  • Is allergic to tetracycline-class antibiotics or to any ingredient in the study medication.
  • Has a history of pseudomembranous colitis or antibiotic-associated colitis.
  • Has a history of hepatitis or liver damage or renal impairment.

Treatment and study plan

Doxycycline hyclate (Doryx)

Drug

150mg/day, oral, delayed release tablets

Other names: Doryx

Doxycycline Hyclate

Drug

100 mg/day, oral, tablets, immediate release

Primary outcomes

  1. Successful Outcome According to Investigator's Global Assessment (IGA)

    Time frame: baseline and 12 weeks

    The Investigator's Global Assessment (IGA) was performed at baseline and at 12 weeks. The IGA score is based on a 5-point acne severity scale from zero (clear) to 4 (severe). Successful outcome is at least a 2-point reduction in IGA score from baseline to 12 weeks.

  2. Change From Baseline in Inflammatory Acne Lesion Count on the Face at 12 Weeks

    Time frame: baseline and 12 weeks

    Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.

Secondary outcomes

  1. Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks

    Time frame: baseline and 12 weeks

    Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of non-inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Registry information

Official study title

Randomized, Open-label Study to Evaluate the Efficacy and Safety of Doryx Tablets Compared to Doxycycline Hyclate in the Treatment of Acne Vulgaris.

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 14, 2008
Registry last updated
Apr 20, 2012

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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