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

NCT ID: NCT02800525

Last Updated: 2016-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-09-30

Brief Summary

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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

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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.

Conditions

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Benign Pigmented Lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Picosecond laser

Intervention Type 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.

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

Group Type ACTIVE_COMPARATOR

Q-switched Nd:YAG laser

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Woraphong Manuskiatti, M.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Woraphong Manuskiatti, Prof., M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Siriraj Hospital

Locations

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Department of Dermatology, Siriraj Hospital, Mahidol University

Bangkok, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Woraphong Manuskiatti, Prof., M.D.

Role: CONTACT

66-2419-9922

Chanida Ungaksornpairote, M.D.

Role: CONTACT

66-2-419-9922

Facility Contacts

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Woraphong - Manuskiatti, Prof.,M.D

Role: primary

+66819150555

Chanida - Ungaksornpairote, M.D.

Role: backup

+66834315359

References

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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.

Reference Type RESULT
PMID: 27227473 (View on PubMed)

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.

Reference Type RESULT
PMID: 26922302 (View on PubMed)

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.

Reference Type RESULT
PMID: 26696500 (View on PubMed)

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

Reference Type RESULT
PMID: 21865801 (View on PubMed)

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.

Reference Type RESULT
PMID: 20887701 (View on PubMed)

Other Identifiers

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Si468/2016 (EC1)

Identifier Type: -

Identifier Source: org_study_id

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