Post-inflammatory hyperpigmentation in patients with solar lentigines who underwent laser treatment Postinflammatory hyperpigmentation, PIH, solar lentigines
Conditions
Interventions
Topical clobetasol propionate 0.05% ointment (apply twice daily for 2 days),Topical clobetasol propionate 0.05% ointment under occlusive dressings (apply 24 hours after laser therapy),Topical brimonid
Active Comparator Drug,Active Comparator Drug,Active Comparator Drug,Placebo Comparator Drug
Topical clobetasol,Topical clobetasol under occlusion,Topical brimonidine,Control
Sponsors
Faculty of Medicine, Srinakharinwirot University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female subjects above 18 years of age 2. Subjects who have at least 8 solar lentigines on the forearms (diagnosed clinically or dermoscopically by a dermatologist). The lesions should be located on 4 different areas of the forearms; including left upper forearm, left lower forearm, right upper forearm, and right lower forearm; and there should be at least 2 lesions in each area. 3. Subjects who are willing to attend the project and sign informed consent form
Exclusion criteria
Exclusion criteria: 1. Subjects who have active inflammatory diseases or infections at the site of treatment 2. Subjects who have photosensitive skin conditions 3. Subjects with a history of hypertrophic scars or keloids 4. Subjects with a history of skin malignancy 5. Subjects who received topical retinoids, hydroquinone, chemical peeling, or other topical whitening agents at the site of treatment within a period of 1 months prior to treatment 6. Subjects who received oral retinoids within 6 months prior to treatment 7. Subjects who underwent non-ablative laser therapy at the site of treatment within a period of 3 months prior to treatment 8. Subjects who underwent ablative laser therapy at the site of treatment within a period of 6 months prior to treatment 9. Subjects who are allergic to topical analgesics, topical corticosteroids, topical brimonidine, petrolatum jelly, or other inactive ingredients of the medication such as propylene glycol, paraffin, sorbitan sesquioleate, carbomer, methylparahydroxybenzoate, phenoxyethanol, glycerol, titanium dioxide, and sodium hydroxide 10. Subjects who have conditions that should avoid using topical brimonidine 11. Subjects who have coagulation disorders 12. Subjects who are pregnant or lactating women 13. Subjects who are likely to have impaired wound healing such as smokers or patients with poorly controlled diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurence of PIH at 2, 4, 8, and 12 weeks after treatment PIH is defined by an increase in pigmentation of each lesion at 4, 8, or 12 weeks after laser treatment, compared with pigmentation at 2 weeks after laser therapy, determined by dermatologists | — |
Secondary
| Measure | Time frame |
|---|---|
| Intensity of PIH at 2, 4, 8 and 12 weeks after laser treatment The degree of PIH will be evaluated from the digital photographs by dermatologists, using a 5-point grading scale,Intensity of PIH (objective) at baseline, and 2, 4, 8 and 12 weeks after laser treatment Objective assessment of melanin index of the selected lesions in each area will be measured using Mexameter MX18,Degree of erythema at 2, 4, 8 and 12 weeks after laser treatment The degree of erythema will be evaluated from the digital photographs by dermatologists, using a 5-point grading scale,Degree of erythema (objective) at baseline, and 2, 4, 8 and 12 weeks after laser treatment Objective assessment of erythema index of the selected lesions in each area will be measured using Mexameter MX18,Improvement of lesions at 2, 4, 8 and 12 weeks after laser treatment The improvement of lesions will be evaluated from the digital photographs by dermatologists, using a 5-point grading scale,Patient satisfaction at the end of the study (week 12) Patient satisfaction in various aspects will be evaluated at the end of the study by the patients using a 5-point grading scale,Duration of wound healing process immediately after laser treatment and at 2 weeks Assessment of duration of wound healing process will be subjectively evaluated in terms of duration of pain, crusting, edema, and erythema,Adverse reactions immediately after treatment, and at 2, 4, 8 and 12 weeks after treatment Adverse reactions, including burning, itching, dryness, scaling, eczematous reaction and other reactions, will be recorded | — |
Countries
Thailand
Contacts
Public ContactPakagamon Tumsutti
Srinakharinwirot University
Outcome results
None listed