St. John's Wort Photodynamic Therapy

NCT05073211 | Completed DMC

• 1 other identifier: B-1906547-003
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acne

Outcome Measures

Primary Outcomes (1)

• acne lesions

  change in the number of acne lesions after the treatment

  1 and 4 weeks after the last treatment

Secondary Outcomes (1)

• sebum secretion rate (μg/cm2)

  1 and 4 weeks after the last treatment

Other Outcomes (2)

• erythema index (arbitrary unit)

  1 and 4 weeks after the last treatment

• skin texture, wrinkles (arbitrary unit)

  1 and 4 weeks after the last treatment

Study Arms (2)

SJW-PDT

EXPERIMENTAL

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

IAA-PDT

ACTIVE COMPARATOR

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

Interventions

PDT 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; SJW-PDT

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients with mild to moderate facial acne
• between 25 and 60 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

Location

Related Publications (1)

• 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.

  PMID: 36946749 DERIVED

MeSH Terms

Conditions

Acne Vulgaris

Interventions

1-phenyl-3,3-dimethyltriazene

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Jung Won Shin, M.D., Ph.D.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: a double-blind split-face randomized controlled design

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: October 11, 2021
• Study Start: June 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 11, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)