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IRCT20260502069236N1 IRCT 2026-05-17 Shahid Beheshti University of Medical Sciences Comparison of the effectiveness of two laser treatment methods for hand rejuvenation Evaluation of the Effectiveness of Fractional CO₂ Laser Alone Versus Combined Fractional CO₂ Laser and Q-Switched Long-Pulsed 1064 nm Laser in Hand Rejuvenation 2026-05-26 anticipated 70 Recruiting https://irct.ir/trial/89792 interventional Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Blinding description: Several dermatologists, blinded to the type of laser used on each hand (CO₂ alone versus CO₂ combined with Q-switched laser), will offer their assessments concerning the comparison of the two hands. N/A Hand Rejuvenation. Intervention 1: Intervention groIn this group, the hand allocated to the combination treatment will receive both Fractional Carbon Dioxide laser and Q-Switched Long-Pulsed Neodymium-Doped Yttrium Aluminum Garnet 1064 nm laser therapy.In each treatment session, Fractional Carbon Dioxide laser therapy will first be applied to the hand skin, followed by Q-Switched Long-Pulsed Neodymium-Doped Yttrium Aluminum Garnet laser treatment on the same area.Treatment will be performed in three sessions with intervals of 4 to 6 weeks between sessions. Prior to treatment initiation, standardized digital photography and skin analysis using the FotoFinder imaging system will be performed.Patients will be evaluated one month and three months after the final treatment session regarding the degree of hand skin rejuvenation, pigmentation changes, skin texture improvement, wrinkle reduction, and possible adverse effects. Intervention 2: Control group: In this group, the hand allocated to the control group will receive treatment with Fractional Carbon Dioxide laser alone.Treatment will be performed in three sessions with intervals of 4 to 6 weeks between sessions. Standardized digital photography and skin analysis using the FotoFinder imaging system will be conducted before treatment initiation.Patients will be followed one month and three months after the final treatment session, and clinical improvement, skin texture and pigmentation changes, and possible adverse effects will be evaluated and recorded. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Hasan Sharifian dorcheh
Tehran - Shariati Street - Shahrdari Street - Minoo Dead End - Skin Research Center
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2274 1507 Hasansh1150@gmail.com Shahid Beheshti University of Medical Sciences scientific Hasan Sharifian dorcheh
Tehran - Shariati St. - Shahrdari St. - Minoo Blvd. - Skin Research Center
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2274 1507 Hasansh1150@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) They should have good overall health Participation should be voluntary They should have no prior history of skin disease 45 years 55 years Female active skin diseases on the hands such as eczema, psoriasis, skin infections, or open wounds a history of abnormal scarring, including hypertrophic scars or keloids use of photosensitizing medications pregnancy or breastfeeding psychiatric disorders or inability to adhere to treatment protocols and follow-up a history of laser treatments or similar procedures on the hands within the past six months systemic or autoimmune diseases such as lupus or scleroderma that may interfere with skin healing severe allergies to light or materials used in the treatment Treatment - Other Placebo Intervention groIn this group, the hand allocated to the combination treatment will receive both Fractional Carbon Dioxide laser and Q-Switched Long-Pulsed Neodymium-Doped Yttrium Aluminum Garnet 1064 nm laser therapy.In each treatment session, Fractional Carbon Dioxide laser therapy will first be applied to the hand skin, followed by Q-Switched Long-Pulsed Neodymium-Doped Yttrium Aluminum Garnet laser treatment on the same area.Treatment will be performed in three sessions with intervals of 4 to 6 weeks between sessions. Prior to treatment initiation, standardized digital photography and skin analysis using the FotoFinder imaging system will be performed.Patients will be evaluated one month and three months after the final treatment session regarding the degree of hand skin rejuvenation, pigmentation changes, skin texture improvement, wrinkle reduction, and possible adverse effects. Control group: In this group, the hand allocated to the control group will receive treatment with Fractional Carbon Dioxide laser alone.Treatment will be performed in three sessions with intervals of 4 to 6 weeks between sessions. Standardized digital photography and skin analysis using the FotoFinder imaging system will be conducted before treatment initiation.Patients will be followed one month and three months after the final treatment session, and clinical improvement, skin texture and pigmentation changes, and possible adverse effects will be evaluated and recorded. Change in the clinical improvement score of hand skin wrinkles based on dermatologist assessment using a four-grade clinical improvement scale. Timepoint: Before treatment, after each treatment session, and at one month and three months following the final treatment session. Method of measurement: This variable will be assessed using both objective and subjective methods. In the objective method, standardized digital photography of both hands will be performed under fixed conditions (constant lighting, angle, distance, and uniform background). Pre- and post-treatment images will be evaluated by two independent dermatologists blinded to the treatment allocation, and the degree of improvement will be reported as a percentage ranging from 0 to 100%. Treatment response will be classified as follows: low response (0–25% improvement), mild response (25–50% improvement), moderate response (50–75% improvement), and excellent response (greater than 75% improvement). In case of disagreement greater than one grade, a third dermatologist will be consulted. In the subjective method, patient satisfaction with treatment outcomes will be recorded through a standardized direct questionnaire. In addition, adverse events including edema, pain, erythema, pruritus, blistering, hypopigmentation, hyperpigmentation, and scarring will be assessed and documented by the treating physician at each visit. Shahid Beheshti University of Medical Sciences Approved 2026-01-07 Ethics Committee of the Skin Research Center of Shahid Beheshti University of Medical Sciences Tehran, Qods Square, Shahrdari Street, not far from Tajrish Square, Tajrish Martyrs Medical Center, Skin Research Center Tehran Tehran Iran (Islamic Republic of)