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Trial record 14 of 233 for:    acne AND Percent

Topical PDT Cream Without Irradiation Source in the Acne Treatment

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ClinicalTrials.gov Identifier: NCT02313467
Recruitment Status : Completed
First Posted : December 10, 2014
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
Dae Hun Suh, Seoul National University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acne, Photodynamic Therapy Drug: Topical application of 1.5% Butenyl ALA Drug: Topical application of sham control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Topical Application of 1.5% Butenyl ALA Without Light Source Irradiation in the Treatment of Acne: a Double Blinded Randomized Controlled Trial.
Study Start Date : January 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Active Comparator: 1.5% Butenyl ALA
Topical application of 1.5% Butenyl ALA per every other day around acne lesions in the face
Drug: Topical application of 1.5% Butenyl ALA
Sham Comparator: Control
Topical application of sham control per every other day around acne lesions in the face
Drug: Topical application of sham control



Primary Outcome Measures :
  1. Percent change of inflammatory acne lesions compared with baseline [ Time Frame: 12 week ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT02313467


Locations
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Korea, Republic of
Seoul National Unviersity
Seoul, Seoul Metropolitan, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Dae Hun Suh, MD Seoul National University Department of Dermatology

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Responsible Party: Dae Hun Suh, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02313467     History of Changes
Other Study ID Numbers: SNUH-PDT2
First Posted: December 10, 2014    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015