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OpenTrials
Completed

NCT Number: NCT02313467

Topical PDT Cream Without Irradiation Source in the Acne Treatment

In this study, the investigators are going to compare the clinical effect and safety of topical application of 1.5% Butenyl ALA cream formula without light source irradiation in the treatment of acne.

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Key information

Conditions

Acne, Photodynamic Therapy Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National Unviersity

Seoul, Seoul Metropolitan, 110-744, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • mild to moderate acne vulgaris (Leeds revised acne grading system score 2-7) at baseline.

Exclusion criteria

  • known pregnancy
  • lactation
  • any medical illness that might influence the results of the study
  • a history of oral acne medication or surgical procedure, including laser treatment, within 6 months of study enrollment
  • use of topical acne medication within 4 weeks of study enrollment.

Treatment and study plan

Topical application of 1.5% Butenyl ALA

Drug

Topical application of sham control

Drug

Primary outcomes

  1. Percent change of inflammatory acne lesions compared with baseline

    Time frame: 12 week

Secondary outcomes

  1. Percent change of non-inflammatory acne lesions compared with baseline

    Time frame: 12 week

  2. Percent change of overall severity of acne lesions compared with baseline

    Time frame: 12 week

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Topical Application of 1.5% Butenyl ALA Without Light Source Irradiation in the Treatment of Acne: a Double Blinded Randomized Controlled Trial.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 10, 2014
Registry last updated
Mar 17, 2015

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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