Benign Pigmented Lesions
Conditions
Keywords
Benign pigmented lesions, Picosecond laser, Q-switched laser
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.
Interventions
DEVICEPicosecond 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.
DEVICEQ-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.
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Doctor 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 | Quartile scale 0-4 |
Secondary
| 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 |
Countries
Thailand
Contacts
Primary ContactWoraphong Manuskiatti, Prof., M.D.
Backup ContactChanida Ungaksornpairote, M.D.
Outcome results
None listed