AcneSJWPDTNCT05073211
St. John's Wort Photodynamic Therapy
A study testing PDT in people with Acne, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- PDT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2020to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with mild to moderate facial acne
- between 25 and 60 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam, 13620
About this study
Official title: 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.
- Conditions
- Acne
- Being tested
- PDT
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDTProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
acne lesions
change in the number of acne lesions after the treatment
Measured: 1 and 4 weeks after the last treatment
Secondary outcomes (1)
sebum secretion rate (μg/cm2)
Sebum secretion rate was measured with Sebumeter SM 815®.
Measured: 1 and 4 weeks after the last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start1 Jun 2020
- Primary completion1 Apr 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- a double-blind split-face randomized controlled design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Won Shin, Seoul National University Bundang Hospital
- Investigators
- Jung Won Shin, M.D., Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073211
- Sponsor's protocol ID
- B-1906547-003
- Acronym
- SJWPDT
- Status last verified
- Sep 2021
- First submitted
- 17 Sep 2021
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36946749
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Split-face Study of Photodynamic Therapy With St. John's Wort Versus Indole-3-acetic Acid for the Treatment of Acne
- ClinicalTrials.gov ID
- NCT05073211
- Acronym / sponsor ID
- SJWPDT / B-1906547-003
- Conditions
- Acne
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- a double-blind split-face randomized controlled design
| Arm | Type | Receives |
|---|---|---|
| SJW-PDT | Experimental | Procedure: PDTParticipants 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. |
| IAA-PDT | Active comparator | Procedure: PDTParticipants 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. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients with mild to moderate facial acne
- between 25 and 60 years old
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDTA 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. | Procedure or surgery | IAA-PDT, SJW-PDT |
Primary outcome
acne lesions
Time frame: 1 and 4 weeks after the last treatment
change in the number of acne lesions after the treatment
1 secondary outcome
sebum secretion rate (μg/cm2)
Time frame: 1 and 4 weeks after the last treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Derived from this study: PubMed 36946749Kim 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.
- Individual participant dataSharing planned: No
Related trials for Acne
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Not yet recruiting
Evaluating a Brightening Serum for Post-Inflammatory Hyperpigmentation
Post-inflammatory Hyperpigmentation, Post-acne Hyperpigmentation
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
Enrolling by invitationPhase 2/3
A Split-Face Comparative Study of Mono Threads Versus Combination With Plasma Gel for the Treatment of Post-Acne Scars
Acne
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung Won Shin, M.D., Ph.D. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PDT in people with Acne, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acne lesions (time frame: 1 and 4 weeks after the last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05073211, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.