Acne, Photodynamic TherapyNCT02313467
Topical PDT Cream Without Irradiation Source in the Acne Treatment
A study testing Topical application of 1.5% Butenyl ALA in people with Acne, Photodynamic Therapy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In this study, the investigators are going to compare the clinical effect and safety of topical application of 1.5% Butenyl ALA cream formula without light source irradiation in the treatment of acne. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne, Photodynamic Therapy
- What is being tested?
- Topical application of 1.5% Butenyl ALA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Feb 2015
- 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 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- mild to moderate acne vulgaris (Leeds revised acne grading system score 2-7) at baseline.
Who cannot join
- known pregnancy
- lactation
- any medical illness that might influence the results of the study
- a history of oral acne medication or surgical procedure, including laser treatment, within 6 months of study enrollment
- use of topical acne medication within 4 weeks of study enrollment.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National Unviersity
Seoul, Seoul Metropolitan, 110-744
About this study
Official title: Topical Application of 1.5% Butenyl ALA Without Light Source Irradiation in the Treatment of Acne: a Double Blinded Randomized Controlled Trial.
In this study, the investigators are going to compare the clinical effect and safety of topical application of 1.5% Butenyl ALA cream formula without light source irradiation in the treatment of acne.
- Conditions
- Acne, Photodynamic Therapy
- Being tested
- Topical application of 1.5% Butenyl ALA, Topical application of sham control
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical application of 1.5% Butenyl ALADrug
Topical application of sham controlDrug
| Study group | Role | What they receive |
|---|---|---|
| 1.5% Butenyl ALA | Active comparator | Topical application of 1.5% Butenyl ALA per every other day around acne lesions in the face Receives: Drug: Topical application of 1.5% Butenyl ALA |
| Control | Sham comparator | Topical application of sham control per every other day around acne lesions in the face Receives: Drug: Topical application of sham control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change of inflammatory acne lesions compared with baseline
Measured: 12 week
Secondary outcomes (2)
Percent change of non-inflammatory acne lesions compared with baseline
Measured: 12 week
Percent change of overall severity of acne lesions compared with baseline
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startJan 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne, Photodynamic TherapyStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dae Hun Suh, Seoul National University Hospital
- Investigators
- Dae Hun Suh, MD, Principal investigator, Seoul National University Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313467
- Sponsor's protocol ID
- SNUH-PDT2
- Status last verified
- Mar 2015
- First submitted
- 8 Dec 2014
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Application of 1.5% Butenyl ALA Without Light Source Irradiation in the Treatment of Acne: a Double Blinded Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02313467
- Acronym / sponsor ID
- SNUH-PDT2
- Conditions
- Acne, Photodynamic Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 10 Dec 2014 (estimated)
- 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.
In this study, the investigators are going to compare the clinical effect and safety of topical application of 1.5% Butenyl ALA cream formula without light source irradiation in the treatment of acne.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.5% Butenyl ALA | Active comparator | Drug: Topical application of 1.5% Butenyl ALATopical application of 1.5% Butenyl ALA per every other day around acne lesions in the face |
| Control | Sham comparator | Drug: Topical application of sham controlTopical application of sham control per every other day around acne lesions in the face |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- mild to moderate acne vulgaris (Leeds revised acne grading system score 2-7) at baseline.
Key exclusion criteria (5 listed)
- known pregnancy
- lactation
- any medical illness that might influence the results of the study
- a history of oral acne medication or surgical procedure, including laser treatment, within 6 months of study enrollment
- use of topical acne medication within 4 weeks of study enrollment.
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 |
|---|---|---|
| Topical application of 1.5% Butenyl ALA | Drug | 1.5% Butenyl ALA |
| Topical application of sham control | Drug | Control |
Primary outcome
Percent change of inflammatory acne lesions compared with baseline
Time frame: 12 week
2 secondary outcomes
Percent change of non-inflammatory acne lesions compared with baseline
Time frame: 12 week
Percent change of overall severity of acne lesions compared with baseline
Time frame: 12 week
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 17 Mar 2015.
Related trials for Acne, Photodynamic Therapy
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.
Dae Hun Suh, MD principal investigator
Seoul National University Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical application of 1.5% Butenyl ALA in people with Acne, Photodynamic Therapy, run by Seoul National University 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 1 inclusion and 5 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 17 Mar 2015. 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. Some participants in this study may receive a placebo. 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?
Percent change of inflammatory acne lesions compared with baseline (time frame: 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2015.