St. John's Wort Photodynamic Therapy

NCT ID: NCT05073211

Last Updated: 2021-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-09-01

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.

Detailed Description

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Conditions

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Acne

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

a double-blind split-face randomized controlled design
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

PDT

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

PDT

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jung-Won Shin

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jung Won Shin, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Countries

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South Korea

References

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Kim BR, Kim M, Na JI, Huh CH, Shin JW. A Randomized Split-Face Study of Photodynamic Therapy With St. John's Wort and Indole-3-Acetic Acid for the Treatment of Acne. Dermatol Surg. 2023 May 1;49(5):483-488. doi: 10.1097/DSS.0000000000003742. Epub 2023 Mar 21.

Reference Type DERIVED
PMID: 36946749 (View on PubMed)

Other Identifiers

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B-1906547-003

Identifier Type: -

Identifier Source: org_study_id

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