post inflammatory hyperpigmentation post inflammatory hyperpigmentation
Conditions
Interventions
Before treatment, topical anesthetic cream will be applied to the treatment area for 45 minutes. Each participant will receive one pass of full-beam 1064 nm picosecond laser, followed by one pass of f
Experimental Device
1064-nm picosecond laser combined with 532-nm picosecond laser
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Participants of any sex aged 20 to 60 years. 2. Participants clinically diagnosed with post-inflammatory hyperpigmentation (PIH) on the face by a dermatologist, classified as moderate PIH (hyperpigmentation covering approximately 30 to 50% of the facial area). 3. Participants who have not previously received any treatment for facial PIH. 4. Participants who voluntarily consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Participants who are pregnant or breastfeeding. 2. Participants with a history of collagen related disorders 3. Participants with dermatitis, open wounds, or active skin infections on the face. 4. Participants with a history of cancer, currently undergoing cancer treatment, or having skin cancer in the treatment area. 5. Participants with immunodeficiency disorders, including those with HIV infection or AIDS. 6. Participants with a history of allergy to local anesthetics. 7. Participants who have received dermal filler or botulinum toxin injections on the face within 6 months prior to enrollment. 8. Participants who smoke or have a history of heavy alcohol consumption 9. Participants who have undergone facial tightening treatments within 6 months prior to enrollment. 10. Participants with a history of hypertrophic scars, keloids, or inflammatory skin lesions in the treatment area. 11. Participants with a history of psychiatric disorders. 12. Participants with any medical condition that, in the investigators opinion, may pose a safety risk during participation. 13. Participants who do not permit photography for treatment evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physician assessments 1 month after 1st treatment, 1 month after 2nd treatment and 1, 3, and 6 months after 3rd treatment Quartile scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Melanin index baseline, 1 month after 1st treatment, 1 month after 2nd treatment and 1, 3, and 6 months after 3rd treatment Mexameter,Erythema index baseline, 1 month after 1st treatment, 1 month after 2nd treatment and 1, 3, and 6 months after 3rd treatment Mexameter,Pigmentation level baseline, 1 month after 1st treatment, 1 month after 2nd treatment and 1, 3, and 6 months after 3rd treatment Antera3D,Redness baseline, 1 month after 1st treatment, 1 month after 2nd treatment and 1, 3, and 6 months after 3rd treatment Antera3D,Safety During each treatment and 1, 3, and 6 months after 3rd treatment Adverse events,Patients improvemnet 1 month after 1st treatment, 1 month after 2nd treatment and 1, 3, and 6 months after 3rd treatment Quartile scale,Pain score During each treatment Visual Analog Scale | — |
Countries
Thailand
Contacts
Public ContactWoraphong Manuskiatti
Department of Dermatology, Faculty of medicine Siriraj hospital, Mahidol university
Outcome results
None listed