Er:YAG Laser for Treatment of Enlarged Pores

Not Applicable

• Conditions: Enlarged Pores

• Registration Number: NCT02544958
• Lead Sponsor: Mahidol University

Brief Summary

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-09-03
• Study First Submitted QC: 2015-09-08
• Study First Posted: 2015-09-09
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-31
• Last Update Posted: 2016-06-01
• Primary Completion: 2016-07
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Visible enlarged pores on both sides of the face
• Fitzpatrick skin type 3-5

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The efficacy of Er:YAG laser in the treatment of enlarged pores (measurement of skin texture using UVA-light video camera)	1 month after 4 treatments	measurement of skin texture using UVA-light video camera

Secondary Outcome Measures

Name	Time	Method
Hyperpigmentation side effect of Er:YAG laser in the treatment of enlarged pores	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	By investigators' observation of hyperpigmentation
Hypopigmentation side effect of Er:YAG laser in the treatment of enlarged pores	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	By investigators' observation of hypopigmentation
Erythema side effect of Er:YAG laser in the treatment of enlarged pores	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	By investigators' observation of erythema
The patients satisfaction using Quartile grading scale of improvement	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	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

Trial Locations

Locations (1)

Department of Dermatology, Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand