Overview

This trial is active, not recruiting.

Condition enlarged pores
Treatment er:yag laser
Sponsor Mahidol University
Start date May 2015
End date July 2016
Trial size 24 participants
Trial identifier NCT02544958, Si 251/2015

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
4 treatments of 1 month interval
er:yag laser
Er:YAG laser treats enlarged pores on both sides of the face for 4 treatments of 1 month interval.

Primary Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 25 years up to 60 years old.

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

Additional Information

Official title The Efficacy and Safety of Erbium:Yttrium Aluminum Garnet Laser for Treatment of Enlarged Pores: A Pilot Study
Principal investigator Woraphong Manuskiatti, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Mahidol University.