An exploratory study on inhibitory effects of Cheongsangbangpoong-tang on inflammatory lesion and facial thermal imaging in patients with Acne Vulgaris classified Wind-Heat pattern

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0001468

Enrollment

Registered

2015-05-06

Start date

2015-10-26

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Participants were prescribed Cheongsanbangpoon-tang or placebo drug three times a day at a dose of 5g after meals for 8 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male and female participants, 19 years and older were eligible for the study if they fulfilled the following criteria: (1) presence of acne vulgaris with more than 10 inflammatory lesions between the margin of the jaw and front of the hairline (2) agreed to the use of only the intervention in this study for acne vulgaris, during the trial period.

Exclusion criteria

Exclusion criteria: The exclusion criteria were as follows: (1) aspartate transaminase (AST) level = 60 IU/L, alanine transaminase (ALT) level = 60 IU/L, and creatinine level > 1.2 mg/d (2) having undergone Western or traditional medical treatment, or having taken oral contraceptives/antibiotics for acne within the 2 weeks prior to recruitment (3) pregnancy, lactation, or preparation for pregnancy (4) unwillingness to comply with the study protocol.

Design outcomes

Primary

Measure	Time frame
percent change from baseline to week 8 in inflammatory acne lesion counts	—

Secondary

Measure	Time frame
percent change from baseline to week 8 in non-inflammatory and total acne lesion counts between treatment and control groups;percent change from baseline to week 4 in inflammatory, non-inflammatory and total acne lesion counts between treatment and control groups;percent change from week 4 to week 8 in inflammatory, non-inflammatory and total acne lesion counts between treatment and control groups;percent change from baseline to week 4 and week 8 in temperature of digital infrared thermal imaging (DITI) points between treatment and control groups;Correlation between inflammatory lesion count and temperature of digital infrared thermal imaging (DITI) points at baseline, at 4 week, and at 8 week;Serum cortisol and dehydroepiandrosterone-sulfate (DHEA-S) were assessed by clinical laboratory tests at weeks 0 (baseline) and 8 (end of the trial).;number rating scale (NRS) and the Investigator Global Assessment scale for Facial Acne Vulgaris;Frequence of abnormal hemoglobin, platelet, liver and kidney function during this trial	—

Measure

Time frame

percent change from baseline to week 8 in non-inflammatory and total acne lesion counts between treatment and control groups;percent change from baseline to week 4 in inflammatory, non-inflammatory and total acne lesion counts between treatment and control groups;percent change from week 4 to week 8 in inflammatory, non-inflammatory and total acne lesion counts between treatment and control groups;percent change from baseline to week 4 and week 8 in temperature of digital infrared thermal imaging (DITI) points between treatment and control groups;Correlation between inflammatory lesion count and temperature of digital infrared thermal imaging (DITI) points at baseline, at 4 week, and at 8 week;Serum cortisol and dehydroepiandrosterone-sulfate (DHEA-S) were assessed by clinical laboratory tests at weeks 0 (baseline) and 8 (end of the trial).;number rating scale (NRS) and the Investigator Global Assessment scale for Facial Acne Vulgaris;Frequence of abnormal hemoglobin, platelet, liver and kidney function during this trial

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Countries

Korea, Republic of

Contacts

Public ContactKyuseok Kim

Kyung Hee University

kuseok@hanmail.net+82-2-958-9499

Outcome results