St. John's Wort Photodynamic Therapy

Study Overview
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Brief Summary
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The investigators aimed to evaluated the efficacy and safety of SJW-PDT compared to indole-3-acetic acid (IAA)-PDT in the treatment of acne. The investigators also investigated the skin rejuvenating effects of SJW-PDT.

Official Title
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A Randomized Split-face Study of Photodynamic Therapy With St. John's Wort Versus Indole-3-acetic Acid for the Treatment of Acne

Conditions
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Acne

Intervention / Treatment
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* Procedure: PDT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with mild to moderate facial acne between 25 and 60 years old Exclusion Criteria: history of oral retinoid treatment with the past 6 months history of oral antibiotics, topical acne treatment, or skin rejuvenation treatment such as lasers and chemical peeling within the month before the start of the study

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: a double-blind split-face randomized controlled design
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SJW-PDT<br>Participants were randomized to receive either the SJW extract or IAA on each split-face. The SJW extract (DR-Light complexTM; Genicos Co., Ltd, Cheongju, Korea) consisted of 70% 1, 3-butylene glycol, and 0.1% hypericin as active ingredients. After cleansing the face gently, participants applied 1.5 ml of 0.5% SJW extract on one half of the face and 1.5 ml of 0.015% IAA (AC gel®; Wellskin, Seoul, Korea) on the other half of the face for 10 minutes under occlusion. | Procedure: PDT<br>* A 630 nm red light and a 520 nm green light of the light-emitting diode (LED) device (Nouvo-GB®) with an intensity of 35 mW⁄cm2 was simultaneously illuminated for 10 minutes (a total light dose of 21 J/cm2). Participants received a total of four treatments at 1-week intervals and were followed up 1 and 4 weeks after the last treatment.<br>|
| Active Comparator: IAA-PDT<br>Participants were randomized to receive either the SJW extract or IAA on each split-face. The SJW extract (DR-Light complexTM; Genicos Co., Ltd, Cheongju, Korea) consisted of 70% 1, 3-butylene glycol, and 0.1% hypericin as active ingredients. After cleansing the face gently, participants applied 1.5 ml of 0.5% SJW extract on one half of the face and 1.5 ml of 0.015% IAA (AC gel®; Wellskin, Seoul, Korea) on the other half of the face for 10 minutes under occlusion. | Procedure: PDT<br>* A 630 nm red light and a 520 nm green light of the light-emitting diode (LED) device (Nouvo-GB®) with an intensity of 35 mW⁄cm2 was simultaneously illuminated for 10 minutes (a total light dose of 21 J/cm2). Participants received a total of four treatments at 1-week intervals and were followed up 1 and 4 weeks after the last treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acne lesions | change in the number of acne lesions after the treatment | 1 and 4 weeks after the last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sebum secretion rate (μg/cm2) | Sebum secretion rate was measured with Sebumeter SM 815®. | 1 and 4 weeks after the last treatment |