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

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

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.

Study Overview

• Status: Unknown
• Conditions: Benign Pigmented Lesions
• Intervention / Treatment: Device: Picosecond laser; Device: Q-switched Nd:YAG laser

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Recruiting
    • Department of Dermatology, Siriraj Hospital, Mahidol University
    • Contact: Woraphong - Manuskiatti, Prof.,M.D; Phone Number: +66819150555; Email: Doctorlaser@gmail.com
    • Contact: Chanida - Ungaksornpairote, M.D.; Phone Number: +66834315359; Email: Meisjoy@hotmail.com
    • Principal Investigator: Woraphong - Manuskiatti, Prof.,M.D.
    • Sub-Investigator: Chanida - Ungaksornpairote, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Side effect occurrence	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
Patients evaluation of improvement using quartile scale	For epidermal lesion: 1 and 3 months after 1 laser treatment. For dermal lesion: 1, 3 and 6 months after 5 laser treatments

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Woraphong Manuskiatti, Prof., M.D., Department of Dermatology, Siriraj Hospital

Publications and helpful links

General Publications

• Friedman DJ. Successful Treatment of a Red and Black Professional Tattoo in Skin Type VI With a Picosecond Dual-Wavelength, Neodymium-Doped Yttrium Aluminium Garnet Laser. Dermatol Surg. 2016 Sep;42(9):1121-3. doi: 10.1097/DSS.0000000000000780. No abstract available.
• Levin MK, Ng E, Bae YS, Brauer JA, Geronemus RG. Treatment of pigmentary disorders in patients with skin of color with a novel 755 nm picosecond, Q-switched ruby, and Q-switched Nd:YAG nanosecond lasers: A retrospective photographic review. Lasers Surg Med. 2016 Feb;48(2):181-7. doi: 10.1002/lsm.22454.
• Chan JC, Shek SY, Kono T, Yeung CK, Chan HH. A retrospective analysis on the management of pigmented lesions using a picosecond 755-nm alexandrite laser in Asians. Lasers Surg Med. 2016 Jan;48(1):23-9. doi: 10.1002/lsm.22443. Epub 2015 Dec 22.
• Bogdan Allemann I, Goldberg DJ. Benign pigmented lesions. Curr Probl Dermatol. 2011;42:81-96. doi: 10.1159/000328267. Epub 2011 Aug 16.
• Bukvic Mokos Z, Lipozencic J, Ceovic R, Stulhofer Buzina D, Kostovic K. Laser therapy of pigmented lesions: pro and contra. Acta Dermatovenerol Croat. 2010;18(3):185-9.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: June 7, 2016
• First Submitted That Met QC Criteria: June 10, 2016
• First Posted (Estimate): June 15, 2016

Study Record Updates

• Last Update Posted (Estimate): September 20, 2016
• Last Update Submitted That Met QC Criteria: September 19, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Q-switched laser; Picosecond laser; Benign pigmented lesions
• Other Study ID Numbers: Si468/2016 (EC1)