TCTR20231024002
Completed
Phase 3
Effects of Topical Corticosteroids, Topical Corticosteroids Under Occlusion, and Topical Brimonidine on the Prevention of Postinflammatory Hyperpigmentation After Q-Switched 532-nm Nd:YAG Laser Treatment of Solar Lentigines
Faculty of Medicine, Srinakharinwirot University0 sites36 target enrollmentOctober 24, 2023
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Post-inflammatory hyperpigmentation in patients with solar lentigines who underwent laser treatment
- Sponsor
- Faculty of Medicine, Srinakharinwirot University
- Enrollment
- 36
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Topical clobetasol, topical clobetasol under occlusion, and topical brimonidine were not found to be significantly effective in reducing the incidence of PIH and intensity of PIH after laser treatment of solar lentigines on the forearms. However, topical clobetasol and topical clobetasol under occlusion might be effective in reducing posttreatment erythema.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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