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

Phase 3

Completed

• Conditions: Post-inflammatory hyperpigmentation in patients with solar lentigines who underwent laser treatment; Postinflammatory hyperpigmentation, PIH, solar lentigines

• Registration Number: TCTR20231024002
• Lead Sponsor: Faculty of Medicine, Srinakharinwirot University

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.

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-12-02
• Study Start: 2023-10-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

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
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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