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

Benign Pigmented Lesions Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02800525
• Other study ID #: Si468/2016 (EC1)
• Status: Recruiting
• Phase: Phase 4
• First received: June 7, 2016
• Last updated: September 19, 2016
• Start date: June 2016
• Est. completion date: September 2018

Study information

• Verified date: June 2016
• Source: Mahidol University
• Contact: Woraphong Manuskiatti, Prof., M.D.
• Phone: 66-2419-9922
• Email: siwmn[@]mahidol.ac.th
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Pigmented Lesions

Intervention

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.
• 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.

Locations

Country	Name	City	State
Thailand	Department of Dermatology, Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (5)

Bogdan Allemann I, Goldberg DJ. Benign pigmented lesions. Curr Probl Dermatol. 2011;42:81-96. doi: 10.1159/000328267. Epub 2011 Aug 16. Review. — View 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. Review. — View 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. — View 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. — View 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 Me — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes