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

NCT02800525 | Unknown Phase 4 DMC

• 1 other identifier: Si468/2016 (EC1)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Pigmented Lesions

Keywords

Benign pigmented lesions; Picosecond laser; Q-switched laser

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Picosecond laser

EXPERIMENTAL

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

Q-switched Nd:YAG laser

ACTIVE COMPARATOR

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

Interventions

Picosecond laser DEVICE

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.

Picosecond laser

Q-switched Nd:YAG laser DEVICE

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.

Q-switched Nd:YAG laser

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Department of Dermatology, Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

RECRUITING

Related Publications (5)

• 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.

  PMID: 27227473 RESULT

• 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.

  PMID: 26922302 RESULT

• 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.

  PMID: 26696500 RESULT

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

  PMID: 21865801 RESULT

• 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.

  PMID: 20887701 RESULT

Study Officials

• Woraphong Manuskiatti, Prof., M.D.

  Department of Dermatology, Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Woraphong Manuskiatti, Prof., M.D.

CONTACT

66-2419-9922; siwmn@mahidol.ac.th

Chanida Ungaksornpairote, M.D.

CONTACT

66-2-419-9922; Meisjoy@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: June 15, 2016
• Study Start: June 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 20, 2016

Record last verified: 2016-06

Locations

TH (1)