St. John's Wort Photodynamic Therapy (SJWPDT)

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

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.

Study Overview

• Status: Completed
• Conditions: Acne
• Intervention / Treatment: Procedure: PDT

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongnam, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SJW-PDT; 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; 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.
Active Comparator: IAA-PDT; 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
erythema index (arbitrary unit)	The erythema index (EI) was measured with Mexameter MX 1® (Courage & Khazaka)	1 and 4 weeks after the last treatment
skin texture, wrinkles (arbitrary unit)	The skin texture and wrinkles were measured with an Antera 3D® camera (Miravex Limited, Dublin, Ireland).	1 and 4 weeks after the last treatment

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Jung Won Shin, M.D., Ph.D., Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: September 28, 2021
• First Posted (Actual): October 11, 2021

Study Record Updates

• Last Update Posted (Actual): October 11, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: B-1906547-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No