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Completed

NCT Number: NCT01194375

A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris

The purpose of this study is to evaluate the safety and efficacy of IDP-107 versus placebo in treating patients with 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 2

Primary location

Ultranova Skincare, Barrie, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Presence of acne vulgaris on the face and neck/trunk
  • Presence of inflammatory and non-inflammatory lesions on the face

Exclusion criteria

  • Presence of any skin condition on the face that could interfere with clinical evaluations
  • Use of any systemic antibiotics or corticosteroids within 4 weeks prior to the Baseline visit
  • Use of any systemic retinoids, such as isotretinoin, within 3 months prior to the Baseline visit
  • Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period

Treatment and study plan

Low Strength IDP-107

Drug

Once a day for 16 weeks

High Strength IDP-107

Drug

Once a day for 16 weeks

Placebo

Drug

Once a day for 16 weeks

Primary outcomes

  1. Change from baseline in the number of inflammatory lesions

    Time frame: Baseline and 22 weeks

  2. Percent of patients who achieve success for the acne global severity score

    Time frame: Baseline and 22 weeks

Secondary outcomes

  1. Change from baseline in the number of non-inflammatory lesions

    Time frame: Baseline and 22 weeks

Sponsors and collaborators

Lead sponsor

Dow Pharmaceutical Sciences

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 3, 2010
Registry last updated
Jul 2, 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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