NCT02544958

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 9, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

1.2 years

First QC Date

September 3, 2015

Last Update Submit

May 31, 2016

Conditions

Enlarged Pores

Keywords

Enlarged poresEr:YAG laser

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

Er:YAG laser

EXPERIMENTAL

4 treatments of 1 month interval

Device: Er:YAG laser

Interventions

Er:YAG laserDEVICE

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

Er:YAG laser

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

Location

Related Publications (5)

  • 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.

    PMID: 19125363BACKGROUND

  • 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.

    PMID: 24155526BACKGROUND

  • 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.

    PMID: 24155527BACKGROUND

  • 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.

    PMID: 17036285BACKGROUND

  • 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.

    PMID: 18318730BACKGROUND

MeSH Terms

Interventions

Lasers, Solid-State

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Woraphong Manuskiatti, M.D.

    Department of Dermatology, Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 3, 2015

First Posted

September 9, 2015

Study Start

May 1, 2015

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

June 1, 2016

Record last verified: 2016-05

Locations

TH(1)