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IRCT20241018063404N1 IRCT 2025-01-08 Islamic Azad University Comparison of the efficacy of laser therapy versus medical therapy for the treatment of infraorbital dark circles Comparison of the efficacy of Alexandrite laser therapy versus medical therapy for the treatment of infraorbital dark circles in patients of dermatology clinic 2024-11-21 anticipated 102 Complete https://irct.ir/trial/79723 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: In this study, a single-blind method has been used. In this approach, participants are unaware of the group allocation. This design was intentionally implemented to prevent any potential bias or psychological influence in the assessment of outcomes. 2 Infraorbital dark circles. Intervention 1: Intervention Group One: The first intervention group consists of 51 individuals who presented with complaints of dark circles under the eyes at Dr. Tehrani's dermatology clinic in Tehran. This group will receive treatment using the Alexandrite laser from Cynosure Elite, an American-made device operating at a wavelength of 755 nm. Participants in this group will undergo treatment over four sessions, spaced 1.5 months apart. During the treatment period, participants will be permitted to use only under-eye sunscreen. Intervention 2: Intervention group Two: Intervention Group Two: The second intervention group comprises 51 individuals who presented with complaints of dark circles under the eyes at Dr. Tehrani's dermatology clinic in Tehran. This group will receive treatment with a modified formulation of the Kligman formula, consisting of a 0.1% betamethasone cream, a 5% hydroquinone cream and a 0.05% tretinoin cream. Participants are required to apply a lentil-sized amount of this topical combination under the eyes every night for a duration of six months. Throughout the treatment period, participants will be permitted to use only the prescribed medications and an under-eye sunscreen. Yes - There is a plan to make this available What will be shared: The individual data of participants in this study will be shared only after ensuring that the identities of individuals are rendered unidentifiable, thereby preserving the privacy of all participants. When: The dissemination of these documents/data files will occur upon the complete conclusion of the research project. In the event that the project is published as a manuscript, access to the data will be granted following the completion of the publication process, and will remain available for a period of up to two years after the article's publication. To whom: Due to the practical relevance of the project's subject matter in the fields of medicine, industry, and aesthetics, access will be granted to individuals who submit requests and are approved and deemed qualified by the project team. Conditions: Any utilization of the data from this study must be coordinated with the project team responsible for its execution and accompanied by a written permission statement from the research team to ensure the preservation of publication rights. Where to obtain: Applicants may contact us via email at the following address (or at a subsequently provided address in the event of any changes): s2000.edu.khoram@gmail.com. How to obtain: Initially, you are required to introduce yourself and your research group in your email. Following this, please provide a comprehensive description of how the data will be utilized and the specific methodologies involved. It is essential to clearly and explicitly articulate the objectives of using the data. Subsequently, necessary arrangements will be coordinated with you by the project team. Comments:
public Sama Khoraminejad
3th Floor, No. 48, Shahid Maleki Alley, West 160 St., Rashid Ave., Tehran Pars
Tehran Iran (Islamic Republic of) 1653959564 +98 21 7788 2168 s2000.edu.khoram@gmail.com Islamic Azad University scientific Sama Khoraminejad
3th Floor, No. 48, Shahid Maleki Alley, West 160 St., Rashid Ave., Tehran Pars
Tehran Iran (Islamic Republic of) 1653959564 +98 21 7788 2168 s2000.edu.khoram@gmail.com Islamic Azad University Iran (Islamic Republic of) Patients having darkness under the eyes referring to the skin clinic Consent to participate in the study 18 years no limit Female Refusal to continue participating in the study Severe medical complication Treatment - Devices Treatment - Drugs Intervention Group One: The first intervention group consists of 51 individuals who presented with complaints of dark circles under the eyes at Dr. Tehrani's dermatology clinic in Tehran. This group will receive treatment using the Alexandrite laser from Cynosure Elite, an American-made device operating at a wavelength of 755 nm. Participants in this group will undergo treatment over four sessions, spaced 1.5 months apart. During the treatment period, participants will be permitted to use only under-eye sunscreen. Intervention group Two: Intervention Group Two: The second intervention group comprises 51 individuals who presented with complaints of dark circles under the eyes at Dr. Tehrani's dermatology clinic in Tehran. This group will receive treatment with a modified formulation of the Kligman formula, consisting of a 0.1% betamethasone cream, a 5% hydroquinone cream and a 0.05% tretinoin cream. Participants are required to apply a lentil-sized amount of this topical combination under the eyes every night for a duration of six months. Throughout the treatment period, participants will be permitted to use only the prescribed medications and an under-eye sunscreen. Infraorbital pigmentation score. Timepoint: Measurement of under-eye pigmentation was conducted at the onset of the study (prior to the initiation of the intervention) and again six months following the commencement of treatment. Method of measurement: Measurement of pigmentation device; Questionnaire. Islamic Azad University Approved 2024-10-09 Research Ethics Committees of Tehran Islamic Azad University Of Medical Sciences 3th Floor, No. 48, Shahid Maleki Alley, West 160 St., Rashid Ave., Tehran Pars Tehran Tehran Iran (Islamic Republic of)