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Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate

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ClinicalTrials.gov Identifier: NCT00635609
Recruitment Status : Completed
First Posted : March 14, 2008
Results First Posted : December 30, 2009
Last Update Posted : April 20, 2012
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Doxycycline hyclate (Doryx) Drug: Doxycycline hyclate Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Open-label Study to Evaluate the Efficacy and Safety of Doryx Tablets Compared to Doxycycline Hyclate in the Treatment of Acne Vulgaris.
Study Start Date : March 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Doxycycline hyclate (Doryx) Drug: Doxycycline hyclate (Doryx)
150mg/day, oral, delayed release tablets
Other Name: Doryx

Active Comparator: Doxycycline hyclate Drug: Doxycycline hyclate
100 mg/day, oral, tablets, immediate release




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00635609


Locations
United States, California
Warner Chilcott Investigational Site
Vista, California, United States, 92083
United States, Florida
Warner Chilcott Investigational Site
Miami, Florida, United States, 33175
United States, Kentucky
Warner Chilcott Investigational Site
Louisville, Kentucky, United States, 40217
United States, New York
Warner Chilcott Investigational Site
Rochester, New York, United States, 14623
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Angelo Secci, MD Warner Chilcott

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00635609     History of Changes
Other Study ID Numbers: PR-08607
First Posted: March 14, 2008    Key Record Dates
Results First Posted: December 30, 2009
Last Update Posted: April 20, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents