Er:YAG Laser for Treatment of Enlarged Pores

Enlarged Pores Clinical Trial

Official title:

The Efficacy and Safety of Erbium:Yttrium Aluminum Garnet Laser for Treatment of Enlarged Pores: A Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02544958
• Other study ID #: Si 251/2015
• Status: Active, not recruiting
• Phase: N/A
• First received: September 3, 2015
• Last updated: May 31, 2016
• Start date: May 2015
• Est. completion date: August 2016

Study information

• Verified date: May 2016
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

To investigate the efficacy of Erbium:Yttrium aluminum garnet laser (Er:YAG) in the treatment of enlarged pores.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enlarged Pores

Intervention

Device:
• Er:YAG laser
Er:YAG laser treats enlarged pores on both sides of the face for 4 treatments of 1 month interval.

Locations

Country	Name	City	State
Thailand	Department of Dermatology, Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 month after 4 treatments	Yes
Secondary	Hyperpigmentation side effect of Er:YAG laser in the treatment of enlarged pores	By investigators' observation of hyperpigmentation	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	Yes
Secondary	Hypopigmentation side effect of Er:YAG laser in the treatment of enlarged pores	By investigators' observation of hypopigmentation	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	Yes
Secondary	Erythema side effect of Er:YAG laser in the treatment of enlarged pores	By investigators' observation of erythema	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	Yes
Secondary	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	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	Yes