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IRCT20250424065457N1 IRCT 2025-05-12 Arak University of Medical Sciences Studying the effect of intralesional injection of tranexamic acid in the treatment of solar lentigo Efficacy of intralesional injection of tranexamic acid versus topical tretinoin 0.05% in treatment of solar lentigines on dorsum of the hands: a controlled randomized clinical trial 2025-05-05 anticipated 54 Complete https://irct.ir/trial/83140 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For each individual, the treatment side with tranexamic acid injection or tretinoin cream was determined based on a coin toss. The treatment side with tranexamic acid injection or cream remained constant throughout the study. 2 solar lentigo. Intervention 1: Intervention group: Tranexamic acid at a concentration of 4 mg/ml diluted with lidocaine is injected locally into the lesion every two weeks for up to 5 sessions. Injections are performed intradermally into each lesion at a rate of 2 microunits of insulin. Intervention 2: Control group: Topical tretinoin cream 0.05% is prescribed as a common treatment for solar lentigo once a night. Yes - There is a plan to make this available What will be shared: All data can be shared after individuals are de-identified. When: Access period starts 12 months after results are published. To whom: Scientific and academic researchers Conditions: Having a specific and legitimate purpose, ensuring data security and limiting access to data to researchers. Where to obtain: To receive the documents, send an email to alirezaabbasi2017@gmail.com. How to obtain: Researchers must sign formal agreements that clearly outline the terms of access and use of information, including clauses such as confidentiality, information security, and how data will be used. Open in Google Translate Comments:
public Alireza Abbasi
No. 15, Ordibehesht 5 Alley, Phase 2, Shahid Beheshti Town
Arak Iran (Islamic Republic of) 3818983885 +98 86 3313 3679 alirezaabbasi2017@gmail.com Arak University of Medical Sciences scientific Alireza Abbasi
No. 15, Ordibehesht 5 Alley, Phase 2, Shahid Beheshti Town
Arak Iran (Islamic Republic of) 3818983885 +98 86 3313 3679 alirezaabbasi2017@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Age over 35 years Presence of relatively symmetrical solar lentigo lesions on the backs of the hands 35 years no limit Both pregnancy breastfeeding History of any treatment for solar lentigo within 6 weeks prior to the start of the study Active skin infections in the area where tranexamic acid injections were given Vascular diseases and accidents such as embolism and vascular thrombosis Treatment - Drugs Treatment - Drugs Intervention group: Tranexamic acid at a concentration of 4 mg/ml diluted with lidocaine is injected locally into the lesion every two weeks for up to 5 sessions. Injections are performed intradermally into each lesion at a rate of 2 microunits of insulin. Control group: Topical tretinoin cream 0.05% is prescribed as a common treatment for solar lentigo once a night. Number of lentigo macules. Timepoint: The number of lentigo macules was assessed before each treatment session and 2 weeks after the last session for both intervention and control groups and recorded in the patient information form. Method of measurement: Counting the number of lentigo macules. Lentigo Overall Improvement Score. Timepoint: The overall improvement score of solar lentigo was assessed before each treatment session from the second session onwards and 2 weeks after the last session for both intervention and control groups and recorded in the patient information form. Method of measurement: Scoring system. Subjective assessment of lesion healing. Timepoint: Subjective assessment of lesion improvement is assessed before each treatment session from the second session onwards and 2 weeks after the last session for both intervention and control groups and recorded in the patient information form. Method of measurement: Scoring system. Assessing complications and pain severity in patients. Timepoint: From the second session onwards, before each session, patients are asked about the side effects of both methods and this is recorded in a questionnaire. Also, from the first session, during the injections, they are asked about the intensity of pain and this is calculated based on the Visual Analogue Scale and recorded in the questionnaire. Method of measurement: question. Arak University of Medical Sciences Approved 2025-04-21 Ethics committee of Arak University of Medical Sciences Faculty of Medicine, University Complex of the Great Prophet (PBUH), Basij Square, Sardasht Arak Markazi Iran (Islamic Republic of)