Enlarged PoresNCT02544958
Er:YAG Laser for Treatment of Enlarged Pores
A study testing Er:YAG laser in people with Enlarged Pores, run by Mahidol University at 1 site in Thailand.
Trial summary
To investigate the efficacy of Erbium:Yttrium aluminum garnet laser (Er:YAG) in the treatment of enlarged pores. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Enlarged Pores
- What is being tested?
- Er:YAG laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteThailand
- Study dates
- May 2015to Aug 2016
- 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
- Visible enlarged pores on both sides of the face
- Fitzpatrick skin type 3-5
Who cannot join
- Patients with lesions with any clinical suspicion of being pre-cancerous or skin malignancies of any kind
- Patients who have photosensitive dermatoses
- Pregnancy and lactation woman
- Patients with wound infections (herpes, other) on the day of treatment
- Patients with moderate and severe inflammatory acne, Immunosuppressed patients, history of vitiligo
- Patients with unrealistic concerns/expectations and inability to do the appropriate post-operative care
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Dermatology, Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700
About this study
Official title: The Efficacy and Safety of Erbium:Yttrium Aluminum Garnet Laser for Treatment of Enlarged Pores: A Pilot Study
To investigate the efficacy of Erbium:Yttrium aluminum garnet laser (Er:YAG) in the treatment of enlarged pores.
Read the detailed description
- Enlarged pores are caused by multifactorial factors such as sex, genetics, aging, etc.
- The gold of the treatment is to recollagenesis of the dermis and resurfacing of the epidermis.
- Modalities that have been proved on their efficacy for enlarged pores treatment included topical retinoic acid, chemical peeling, intense pulsed light, radiofrequency device, laser such as Q-switched and Long Pulsed Neodymium-Doped Yttrium-Aluminum-Garnet (Nd:YAG) 1,064nm, Long pulse duration pulsed dye laser 595nm, etc.
- Er:YAG laser is an ablative laser which creates both recollagenesis and resurfacing. It ha been proved to be safe and effective in the treatment of atrophic acne scar.
- However, the efficacy of this laser for enlarged treatment has not yet been established.
- Conditions
- Enlarged Pores
- Being tested
- Er:YAG laser
- Keywords
- Enlarged pores, Er:YAG laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Er:YAG laserDevice
Er:YAG laser treats enlarged pores on both sides of the face for 4 treatments of 1 month interval.
| Study group | Role | What they receive |
|---|---|---|
| Er:YAG laser | Experimental | 4 treatments of 1 month interval Receives: Device: Er:YAG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of Er:YAG laser in the treatment of enlarged pores (measurement of skin texture using UVA-light video camera)
measurement of skin texture using UVA-light video camera
Measured: 1 month after 4 treatments
Secondary outcomes (4)
Hyperpigmentation side effect of Er:YAG laser in the treatment of enlarged pores
By investigators' observation of hyperpigmentation
Measured: Follow-up period:1 month after 1st treatment, 1 month after 2nd treatment, 1 month after 3rd treatment and 1-,3-,and 6-month after 4th treatment
Hypopigmentation side effect of Er:YAG laser in the treatment of enlarged pores
By investigators' observation of hypopigmentation
Measured: Follow-up period:1 month after 1st treatment, 1 month after 2nd treatment, 1 month after 3rd treatment and 1-,3-,and 6-month after 4th treatment
Erythema side effect of Er:YAG laser in the treatment of enlarged pores
By investigators' observation of erythema
Measured: Follow-up period:1 month after 1st treatment, 1 month after 2nd treatment, 1 month after 3rd treatment and 1-,3-,and 6-month after 4th treatment
The patients satisfaction using Quartile grading scale of improvement
By using Quartile grading scale of improvement; 0 = not improve, 1= 1-25% improvement, 2 = 26-50% improvement, 3 = 51-75% improvement and 4 = 76-100% improvement
Measured: Follow-up period:1 month after 1st treatment, 1 month after 2nd treatment, 1 month after 3rd treatment and 1-,3-,and 6-month after 4th treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Enlarged PoresStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woraphong Manuskiatti, M.D., Mahidol University
- Investigators
- Woraphong Manuskiatti, M.D., Principal investigator, Department of Dermatology, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544958
- Sponsor's protocol ID
- Si 251/2015
- Status last verified
- May 2016
- First submitted
- 3 Sep 2015
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roh MR, Chung HJ, Chung KY. Effects of various parameters of the 1064 nm Nd:YAG laser for the treatment of enlarged facial pores. J Dermatolog Treat. 2009;20(4):223-8. doi: 10.1080/09546630802647244.
PubMed 19125363Roh M, Goo B, Jung J, Chung H, Chung K. Treatment of enlarged pores with the quasi long-pulsed versus Q-switched 1064 nm Nd:YAG lasers: A split-face, comparative, controlled study. Laser Ther. 2011;20(3):175-80. doi: 10.5978/islsm.20.175.
PubMed 24155526Chung H, Goo B, Lee H, Roh M, Chung K. Enlarged pores treated with a combination of Q-switched and micropulsed 1064 nm Nd:YAG laser with and without topical carbon suspension: A simultaneous split-face trial. Laser Ther. 2011;20(3):181-8. doi: 10.5978/islsm.20.181.
PubMed 24155527Kunzi-Rapp K, Dierickx CC, Cambier B, Drosner M. Minimally invasive skin rejuvenation with Erbium: YAG laser used in thermal mode. Lasers Surg Med. 2006 Dec;38(10):899-907. doi: 10.1002/lsm.20380.
PubMed 17036285Tay YK, Kwok C. Minimally ablative erbium:YAG laser resurfacing of facial atrophic acne scars in Asian skin: a pilot study. Dermatol Surg. 2008 May;34(5):681-5. doi: 10.1111/j.1524-4725.2008.34127.x. Epub 2008 Mar 3.
PubMed 18318730
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Erbium:Yttrium Aluminum Garnet Laser for Treatment of Enlarged Pores: A Pilot Study
- ClinicalTrials.gov ID
- NCT02544958
- Acronym / sponsor ID
- Si 251/2015
- Conditions
- Enlarged Pores
- Keywords
- Enlarged pores, Er:YAG laser
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 9 Sep 2015 (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.
To investigate the efficacy of Erbium:Yttrium aluminum garnet laser (Er:YAG) in the treatment of enlarged pores.
Detailed description
- Enlarged pores are caused by multifactorial factors such as sex, genetics, aging, etc.
- The gold of the treatment is to recollagenesis of the dermis and resurfacing of the epidermis.
- Modalities that have been proved on their efficacy for enlarged pores treatment included topical retinoic acid, chemical peeling, intense pulsed light, radiofrequency device, laser such as Q-switched and Long Pulsed Neodymium-Doped Yttrium-Aluminum-Garnet (Nd:YAG) 1,064nm, Long pulse duration pulsed dye laser 595nm, etc.
- Er:YAG laser is an ablative laser which creates both recollagenesis and resurfacing. It ha been proved to be safe and effective in the treatment of atrophic acne scar.
- However, the efficacy of this laser for enlarged treatment has not yet been established.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Er:YAG laser | Experimental | Device: Er:YAG laser4 treatments of 1 month interval |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Visible enlarged pores on both sides of the face
- Fitzpatrick skin type 3-5
Key exclusion criteria (6 listed)
- Patients with lesions with any clinical suspicion of being pre-cancerous or skin malignancies of any kind
- Patients who have photosensitive dermatoses
- Pregnancy and lactation woman
- Patients with wound infections (herpes, other) on the day of treatment
- Patients with moderate and severe inflammatory acne, Immunosuppressed patients, history of vitiligo
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 |
|---|---|---|
| Er:YAG laserEr:YAG laser treats enlarged pores on both sides of the face for 4 treatments of 1 month interval. | Device | Er:YAG laser |
Primary outcome
The efficacy of Er:YAG laser in the treatment of enlarged pores (measurement of skin texture using UVA-light video camera)
Time frame: 1 month after 4 treatments
measurement of skin texture using UVA-light video camera
4 secondary outcomes
Hyperpigmentation side effect of Er:YAG laser in the treatment of enlarged pores
Time frame: Follow-up period:1 month after 1st treatment, 1 month after 2nd treatment, 1 month after 3rd treatment and 1-,3-,and 6-month after 4th treatment
Hypopigmentation side effect of Er:YAG laser in the treatment of enlarged pores
Time frame: Follow-up period:1 month after 1st treatment, 1 month after 2nd treatment, 1 month after 3rd treatment and 1-,3-,and 6-month after 4th treatment
Erythema side effect of Er:YAG laser in the treatment of enlarged pores
Time frame: Follow-up period:1 month after 1st treatment, 1 month after 2nd treatment, 1 month after 3rd treatment and 1-,3-,and 6-month after 4th treatment
The patients satisfaction using Quartile grading scale of improvement
Time frame: Follow-up period:1 month after 1st treatment, 1 month after 2nd treatment, 1 month after 3rd treatment and 1-,3-,and 6-month after 4th treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
- Background: PubMed 19125363Roh MR, Chung HJ, Chung KY. Effects of various parameters of the 1064 nm Nd:YAG laser for the treatment of enlarged facial pores. J Dermatolog Treat. 2009;20(4):223-8. doi: 10.1080/09546630802647244.
- Background: PubMed 24155526Roh M, Goo B, Jung J, Chung H, Chung K. Treatment of enlarged pores with the quasi long-pulsed versus Q-switched 1064 nm Nd:YAG lasers: A split-face, comparative, controlled study. Laser Ther. 2011;20(3):175-80. doi: 10.5978/islsm.20.175.
- Background: PubMed 24155527Chung H, Goo B, Lee H, Roh M, Chung K. Enlarged pores treated with a combination of Q-switched and micropulsed 1064 nm Nd:YAG laser with and without topical carbon suspension: A simultaneous split-face trial. Laser Ther. 2011;20(3):181-8. doi: 10.5978/islsm.20.181.
- Background: PubMed 17036285Kunzi-Rapp K, Dierickx CC, Cambier B, Drosner M. Minimally invasive skin rejuvenation with Erbium: YAG laser used in thermal mode. Lasers Surg Med. 2006 Dec;38(10):899-907. doi: 10.1002/lsm.20380.
- Background: PubMed 18318730Tay YK, Kwok C. Minimally ablative erbium:YAG laser resurfacing of facial atrophic acne scars in Asian skin: a pilot study. Dermatol Surg. 2008 May;34(5):681-5. doi: 10.1111/j.1524-4725.2008.34127.x. Epub 2008 Mar 3.
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.
Woraphong Manuskiatti, M.D. principal investigator
Department of Dermatology, Siriraj 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 Er:YAG laser in people with Enlarged Pores, run by Mahidol University at 1 site in Thailand.
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 6 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: status not confirmed, as of the sponsor's last update on 1 Jun 2016. 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 Thailand. 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?
Results are not available in the source record.
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?
The efficacy of Er:YAG laser in the treatment of enlarged pores (measurement of skin texture using UVA-light video camera) (time frame: 1 month after 4 treatments). 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 NCT02544958, which also lists 5 linked publications.
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 1 Jun 2016.