Treatment of Freckles by Intradermal Tranexamic Acid Versus Q Switched KTP Laser.
Comparative Study for the Treatment of Freckles by Intradermal Tranexamic Acid Versus Q Switched KTP Laser (532nm)
연구 개요
상태
상세 설명
One side of the face will receive QS KTPlaser at a wavelength of 532 nm, spot size 2-3 mm , power 1-1.5J/cm2 and the clinical end point is just frosting.Sessions will be every month for 2 months.
The other side of the face will be assigned to TXA intradermal microinjection in the same session using Kapron 500mg/5ml ampoules (Amoun Pharmaceutical Company), the dose of 1 ml syringe with 100mg/ml. TXA will prepared under sterile conditions. Injections will be applied intradermally on freckles area at.
The sessions of TXA will be every 2 weeks for 2 months.
Postoperatively, topical antibiotic ointment and steriod will be applied. Sunscreen then applied until the next treatment in order to minimize reactive hyperpigmentations.
Follow up after treatment monthly for 2 month.
연구 유형
등록 (예상)
단계
- 1단계
연락처 및 위치
연구 장소
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Cairo, 이집트, 11956
- 모병
- Kasr El Ainy university hospital
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연락하다:
- Samar Tuqan
- 전화번호: 02 01003133495
- 이메일: samartuqan@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Both genders
- Age group > 18years old.
Exclusion Criteria:
- Pregnant and lactating females.
- Keloid and scarring tendancy
- Usage of invasive or semi invasive procedures for treatment of freckles such as chemical peeling , dermaroller..etc. 2 months prior to the study.
- Oral Isotretinoin 6 months prior to the study.
- Active herpetic lesions.
- Any concurrent active skin disease within the treated area.
- Photosensitive skin conditions such as systemic lupus erythematous.
- History of delayed wound healing.
- Bleeding diathesis.
- Medical conditions such as autoimmune diseases.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Participants with freckles (one side of the face)
one randomized side of the face will be treated by Intradermal Tranexamic acid
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Ampoules used for intradermal injection
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활성 비교기: Participants with freckles (other side of the face)
other side will be treated by Q switched KTP laser
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LASER
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pigmentation and severity index by clinical evaluation
기간: 6 months to 1 year
|
Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up
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6 months to 1 year
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Melanin Index change by spectrophotometer
기간: 6 months to 1 year
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Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up
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6 months to 1 year
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Blinded observers' evaluation
기간: 6 months to 1 year
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Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up
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6 months to 1 year
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Patient satisfaction rate
기간: 6 months to 1 year
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Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up
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6 months to 1 year
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .