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Effectiveness and safety of Picosecond laser for the treatment of dark lips, A pilot study

Phase 4
Completed
Conditions
Dark lip
Registration Number
TCTR20201208001
Lead Sponsor
Institute of Dermatology, Department of medical services
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
24
Inclusion Criteria

1.Age over 18 year-old
2.Fitzpatrick skin types IV-V
3.Able to attend every appointment assigned
4.Willing to participate in the study and signed the inform consent

Exclusion Criteria

1.Presence of disease or condition such as fixed drug eruption, Pigmented contact dermatitis, discoid lupus erythematosus of the lips, Lichen planus of the lips, Labial lentigines, Peutz-Jegher syndrome, Addison’s syndrome
2.Pregnancy or lactation
3.Previously treated with energy base devices within 3 months
4.Previously treated with topical bleaching agents within 1 month
5.Active skin infection or dermatitis around the treated area
6.History of tattooing with pink or red color
7.Current smoking
8.Systemic retinoid within the past 6 months
9.Heavy sun exposure
10.Currently on systemic treatment: Hydroxychloroquine, Clofazimine, Zidovudine, Minocycline

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Percent change in melanin index Week 0, week 4, week 8, week 12, week 24 Mexameter ®MX 18 spectrophotometer
Secondary Outcome Measures
NameTimeMethod
Improvement scale week 4, week 8, week 12, week 24 Rating scale by blinded dermatologists,Patient satisfaction Week 24 Patient satisfaction rating scale,Adverse effects Week 0, week 4, week 8, week 12, week 24 Evaluated from patients and attending dermatologists
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