Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Picosecond and Q-switched Laser for Benign Pigmented Lesions Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02800525
Recruitment Status : Unknown
Verified June 2016 by Woraphong Manuskiatti, M.D., Mahidol University.
Recruitment status was:  Recruiting
First Posted : June 15, 2016
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
Woraphong Manuskiatti, M.D., Mahidol University

Brief Summary:
The objective of this study is to evaluate the efficacy and safety of picosecond 532 and 1,064 nanometers laser in the treatment of benign pigmented lesions compared with q-switched 532 and 1,064 nanometers laser.

Condition or disease Intervention/treatment Phase
Benign Pigmented Lesions Device: Picosecond laser Device: Q-switched Nd:YAG laser Phase 4

Detailed Description:

Benign pigmented lesions can be divided into epidermal lesions such as freckles, lentigines, solar lentigines or cafe au lait macules and dermal lesions such as Nevus of Ota or Hori's nevus.

Q-switched 532 and 1064 nm lasers were reported to be safe and effective in the treatment of these benign pigmented lesions. By using selective photothermolysis theory, both q-switched 532 and 1064 nm lasers target on melanin causes photomechanical destruction of the melanin. However, the occurrence of post inflammatory hyperpigmentation (PIH) were reported especially in patients with darker skin type.

Recently, picosecond 532, 755, 1064 nm laser was reported to treat benign pigmented lesions effectively. With their ultra short pulse duration (picosecond domain), it is ideally believed to be pure photomechanical effects without thermal injury to surrounding tissue. As a result, the incident of PIH should be reduced.

The investigators then aimed to compared the efficacy and efficacy of different pulse duration between nanosecond and picosecond laser in the treatment of benign pigmented lesions.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Comparison of Picosecond 532 and 1,064 Nanometers Laser and Q-switched Nd:YAG 532 and 1,064 Nanometers Laser in the Treatment of Benign Pigmented Lesions: A Randomized Controlled Trial
Study Start Date : June 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Arm Intervention/treatment
Experimental: Picosecond laser

The pigmented lesions on this half-side of the face would be treated with picosecond laser.

For epidermal lesions, 1 laser treatment would be performed. For dermal lesions, 5 laser treatments would be performed every 3 month-interval.

The wavelength of 532 or 1064 nm would be chosen for appropriate lesions

Device: Picosecond laser
Picosecond 532 and 1064 nm laser Treatment of facial pigmented lesions. The energy using depends on the endpoint of immediate whitening of the lesions. The wavelength using depends on the depth of lesions.

Active Comparator: Q-switched Nd:YAG laser

The pigmented lesions on this half-side of the face would be treated with q-switched Nd:YAG laser.

For epidermal lesions, 1 laser treatment would be performed. For dermal lesions, 5 laser treatments would be performed every 3 month-interval.

The wavelength of 532 or 1064 nm would be chosen for appropriate lesions

Device: Q-switched Nd:YAG laser
Q-switched Nd-YAG 532 and 1064 nm laser. Treatment of facial pigmented lesions. The energy using depends on the endpoint of immediate whitening of the lesions. The wavelength using depends on the depth of lesion.




Primary Outcome Measures :
  1. Doctor evaluation of improvement using quartile scale [ Time Frame: For epidermal lesion: 1 and 3 months after 1 laser treatment. For dermal lesion: 1, 3 and 6 months after 5 laser treatments ]
    Quartile scale 0-4


Secondary Outcome Measures :
  1. Side effect occurrence [ Time Frame: immediately after treatments, 2, 3, 4, and 12 weeks after the 1st laser treatment, and added more 1, 3 and 6 months after 5 laser treatments for dermal lesions ]
  2. Patients evaluation of improvement using quartile scale [ Time Frame: For epidermal lesion: 1 and 3 months after 1 laser treatment. For dermal lesion: 1, 3 and 6 months after 5 laser treatments ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age >18
  • having any benign pigmented lesions on both sides of the face or any tattoo on any part of body which would like to be removed
  • Fitzpatrick skin phototype 3-5

Exclusion Criteria:

  • Previously treated with any laser within 3 months before enrollment into the study
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800525


Contacts
Layout table for location contacts
Contact: Woraphong Manuskiatti, Prof., M.D. 66-2419-9922 siwmn@mahidol.ac.th
Contact: Chanida Ungaksornpairote, M.D. 66-2-419-9922 Meisjoy@hotmail.com

Locations
Layout table for location information
Thailand
Department of Dermatology, Siriraj Hospital, Mahidol University Recruiting
Bangkok, Thailand, 10700
Contact: Woraphong - Manuskiatti, Prof.,M.D    +66819150555    Doctorlaser@gmail.com   
Contact: Chanida - Ungaksornpairote, M.D.    +66834315359    Meisjoy@hotmail.com   
Principal Investigator: Woraphong - Manuskiatti, Prof.,M.D.         
Sub-Investigator: Chanida - Ungaksornpairote, M.D.         
Sponsors and Collaborators
Mahidol University
Investigators
Layout table for investigator information
Principal Investigator: Woraphong Manuskiatti, Prof., M.D. Department of Dermatology, Siriraj Hospital
Publications of Results:
Layout table for additonal information
Responsible Party: Woraphong Manuskiatti, M.D., Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT02800525    
Other Study ID Numbers: Si468/2016 (EC1)
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: June 2016
Keywords provided by Woraphong Manuskiatti, M.D., Mahidol University:
Benign pigmented lesions
Picosecond laser
Q-switched laser