MedPath

The effectiveness and safety of a Picosecond laser 1064-nm for treatment of lip hyperpigmentation in Thai populatio

Phase 4
Conditions
lip hyperpigmentation
Lip
Registration Number
TCTR20231005005
Lead Sponsor
Institute of Dermatology
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Enrolling by invitation
Sex
All
Target Recruitment
41
Inclusion Criteria

1. Lip hyperpigmentation characterized by bilateral hyperpigmented patch on upper and/or lower lip

Exclusion Criteria

1. Lip hyperpigmentation from disease such as lichen planus, lupus erythematosus, pemphigus, pemphigoid, fixed drug eruptions, pigmented contact cheilitis, orofacial granulomatosis, ephelides, labial melanotic macule, acquired dermal melanocytosis, melanoacanthoma, lentigines, nevus, malignant melanoma, pigmented Bowen disease, squamous cell carcinoma, melanoma, actinic cheilitis, Lentiginosis syndromes, Addison disease, Cushing disease, Nelson syndrome, acromegaly, hyperthyroidism, and hemochromatosis which diagnose by history taking and physical examination
2. History of procedures at lip such as tattoo, filler injection or laser
3. History of keloid or hypertrophic scar
4. History of labial herpes infection
5. Infection at lip
6. Pregnancy or breast feeding
7. History of smoking
8. History of drugs such as minocycline, zidovudine, cyclophosphamide, doxorubicin, escitalopram, levodopa, nicotine and tacrolimus

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Melanin index at 6 months after end of the laser Mexameter
Secondary Outcome Measures
NameTimeMethod
Physician assessment at 6 months after end of the laser Physician assess percentages of improvement of lip hyperpigmentation,Patient satisfaction at 6 months after end of the laser Patient reported outcome using a customer satisfaction scores
© Copyright 2025. All Rights Reserved by MedPath