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Completed

NCT Number: NCT00437151

Analysis of Adherence & Associated Factors in Teenagers Undergoing Treatment of Acne Vulgaris With Differin® Gel 0.1%

The primary objective of this study is to investigate potential differences in treatment adherence by teenagers among four interventions during treatment for acne.

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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

About this study

Same as above.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adolescent subjects with a diagnosis of moderate to severe Acne vulgaris

Exclusion criteria

  • Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring more than topical treatment (e.g. oral isotretinoin)

Treatment and study plan

More frequent than normal office visits

Other

Mode of patient reminder

Electronic reminders (voice, e-mail, text messages)

Other

Mode of patient reminder

Parenteral involvement / intervention reminders

Other

Mode of patient reminder

No intervention or reminders

Other

Mode of patient reminder

Primary outcomes

  1. Efficacy - Percent adherence calculated from MEMS Caps readings

    Time frame: 12 weeks

Secondary outcomes

  1. Efficacy - lesion counts; percent adherence as calculated by product weights and by Subject's Diary; Global Severity Assessment; Global Assessment of Improvement; Subject questionnaire

    Time frame: 12 weeks

  2. Safety - tolerability and adverse event reporting

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

An Analysis of Adherence and Associated Factors in Subjects Undergoing Differin® Gel, 0.1% Treatment of Moderate to Severe Acne Vulgaris.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 19, 2007
Registry last updated
Jul 29, 2022

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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