- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02544958
Er:YAG Laser for Treatment of Enlarged Pores
May 31, 2016 updated by: Woraphong Manuskiatti, M.D., Mahidol University
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.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bangkok, Thailand, 10700
- Department of Dermatology, Siriraj Hospital, Mahidol University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Visible enlarged pores on both sides of the face
- Fitzpatrick skin type 3-5
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Er:YAG laser
4 treatments of 1 month interval
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Er:YAG laser treats enlarged pores on both sides of the face for 4 treatments of 1 month interval.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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measurement of skin texture using UVA-light video camera
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1 month after 4 treatments
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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By investigators' observation of hyperpigmentation
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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
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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
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By investigators' observation of hypopigmentation
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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
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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
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By investigators' observation of erythema
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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
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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
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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
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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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Woraphong Manuskiatti, M.D., Department of Dermatology, Siriraj Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Roh 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.
- Chung 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.
- Kunzi-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.
- Tay 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Anticipated)
July 1, 2016
Study Completion (Anticipated)
August 1, 2016
Study Registration Dates
First Submitted
September 3, 2015
First Submitted That Met QC Criteria
September 8, 2015
First Posted (Estimate)
September 9, 2015
Study Record Updates
Last Update Posted (Estimate)
June 1, 2016
Last Update Submitted That Met QC Criteria
May 31, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Si 251/2015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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