The effectiveness of intradermal platelet-rich plasma for the treatment of acquired bilateral nevus of Ota-like macules (Hori's nevus), in Institute of dermatology, Thailand, pilot study

Phase 2

• Conditions: Acquired bilateral nevus of Ota-like macule; platelet rich plasma; Nevus; Nevus of Hori

• Registration Number: TCTR20230113001
• Lead Sponsor: Institute of Dermatology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-13
• Study Completion: 2023-05-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: nknown
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Patients between the ages of 25 and 65 with bilateral Hori's nevus

Exclusion Criteria

1. Pregnancy and breastfeeding
2. History of PRP allergy
3. History of bleeding disorder such as thalassemia or thrombocytopenia
4. History of blood-borne disease include hepatitis B, hepatitis C or HIV
5. Patient who currently on anti-oxidant supplement such as vitamin C, vitamin E within 3 months prior.
6. Patient who got chemotherapy and anti-coagulant within three months prior to the study
7. Patient who had done LASER or IPL within three months prior to the study
8. Patient who concomitant use of whitening agents, chemical peeling within three months prior to the study
9. Patient who significantly had co-existing hyperpigmented lesion except Hori's nevus
10. Patient who has any active skin disease on the PRP injected area such as infection, skin cancer, dermatitis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hori nevus area and severity baseline (week 0 of the study) and the two-week, four-week, eight-week, and twelve-week post-treatment follow-ups (week 8, 10, 14 and 18 of the study) Modified derml pigmentation area and severity index

Secondary Outcome Measures

Name	Time	Method
Melanin measurements baseline (week 0 of the study) and the two-week, four-week, eight-week, and twelve-week post-treatment follow-ups (week 8, 10, 14 and 18 of the study) Melanin index,Brightening of the lesion the two-week, four-week, eight-week, and twelve-week post-treatment follow-ups (week 8, 10, 14 and 18 of the study) Brightening score,Patients satisfaction the two-week, four-week, eight-week, and twelve-week post-treatment follow-ups (week 8, 10, 14 and 18 of the study) Patients satisfaction score,Side effect On each session, short-term side effect will be collected on day 1 and day 3 post-tx. long-term side effect will be collected at the 2-wk, 4-wk, 8-wk, and 12-wk post-tx followup Pain score, edema score, erythema(yes or no), hyperpigmentation (yes or no), infection ( yes or no), transient ischemia (yes or no), bruise (yes or no), papules (yes or no), pustules (yes or no)