Clinical trial NCT02800525: Comparison of Picosecond and Q-switched Laser for Benign Pigmented Lesions 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Benign Pigmented Lesions
Keywords: Benign pigmented lesions
Picosecond laser
Q-switched laser
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Doctor evaluation of improvement using quartile scale
timeFrame: For epidermal lesion: 1 and 3 months after 1 laser treatment. For dermal lesion: 1, 3 and 6 months after 5 laser treatments
Secondary outcomes:
measure: Side effect occurrence
timeFrame: 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
measure: Patients evaluation of improvement using quartile scale
timeFrame: For epidermal lesion: 1 and 3 months after 1 laser treatment. For dermal lesion: 1, 3 and 6 months after 5 laser treatments
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Dermatology, Siriraj Hospital, Mahidol University
Study officials:
affiliation: Department of Dermatology, Siriraj Hospital
name: Woraphong Manuskiatti, Prof., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Bogdan Allemann I, Goldberg DJ. Benign pigmented lesions. Curr Probl Dermatol. 2011;42:81-96. doi: 10.1159/000328267. Epub 2011 Aug 16.
citation: 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.