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IRCT20250316065097N1 IRCT 2026-06-13 Shahid Beheshti University of Medical Sciences Comparison of hand rejuvenation using Carbin dioxide Laser with and without platelet-rich plasma Comparison of the efficacy of combination therapy of Carbon Dioxide Laser Combined with Platelet-Rich Plasma versus Carbon Dioxide Laser alone in hand rejuvenation 2026-07-06 anticipated 13 Recruiting https://irct.ir/trial/87915 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Other, Other design features: Patients with hand wrinkle is the population of the study who referred to the skin clinic of Loghman Hakim Hospital in 1405-1407. The study method is as follows: 10 patients referred to the skin clinic of Loghman Hakim Hospital for 3 times at intervals of 4-6 weeks and after obtaining a consent form from the patient, CO2 laser is performed on both hands for all patients. PRP is injected into one hand and normal saline is injected into the other hand. Before each procedure, a photo is taken and compared and scored. The scores are about texture/wrinkles/pigmentation and overall improvement and as follows: no improvement = 0 / improvement of 25-1% = 1 / improvement of 26-50% = 2 / improvement of 51-75% = 3 / improvement of 76-100% = 4, which are reviewed blindly by two dermatologists and patients. The final follow-up of the patient is one month after the last session of PRP injection and CO2 laser. Washing Hands with soap and water and covering hands with a thin layer of local anesthetic for 20 minutes is the first stage. Then, laser is performed on both hands with parameters total fluence: 1.5 j/cm2/pulse energy: 1.5 mj/density: 9.6 watt: 30w. To prepare PRP, the patient's blood is taken and centrifuged once at 1200/10 and once at 1600/10. Then, CO2 laser is performed on all patients and PRP is injected into one hand and normal saline is injected into the other hand. After treatment, patients are advised to use zinc oxide ointment and avoid sunlight.At the end of the study, the photos are compared blindly by two independent dermatologists and the rate of improvement is reported as a percentage from zero to one hundred. Complications such as hypopigmentation, hyperpigmentation, scarring, atrophy, and complications such as edema, pain, burning, itching, redness, blisters, bleeding, and crusting will be recorded through a questionnaire from the patients during the procedure, Randomization description: Simple randomization will be used in this study. The unit of randomization is each hand rather than the patient; therefore, in each participant, one hand will be allocated to the intervention group (fractional CO₂ laser combined with platelet-rich plasma [PRP]) and the contralateral hand will be allocated to the control group (fractional CO₂ laser combined with normal saline). No block or stratified randomization will be performed. The random allocation sequence will be generated before the start of the study by an independent individual who is not involved in participant recruitment, treatment, or outcome assessment, using computer-generated random numbers. Based on this sequence, either the right or left hand of each participant will be assigned to the intervention group. To ensure allocation concealment, the randomization sequence will be placed in sequentially numbered, sealed, opaque envelopes. After confirmation of eligibility criteria and obtaining written informed consent, the corresponding envelope will be opened in numerical order and treatment allocation will be determined. Therefore, the investigator responsible for participant enrollment will remain unaware of the treatment assignment until allocation is completed, Blinding description: This study was designed as a double-blind trial. The participants were blinded to the type of injectable treatment administered to each hand. Platelet-rich plasma (PRP) and normal saline were prepared in identical syringes, and injections were performed immediately after fractional CO₂ laser treatment, making it impossible for participants to distinguish between the two interventions. The outcome assessors were also blinded to the treatment allocation. Clinical photographs obtained before each treatment session and at follow-up visits were independently evaluated by two dermatologists who were unaware of the treatment assignment of each hand. The treating physician who performed the laser procedure and injections was not involved in outcome assessment or data analysis. N/A Hand rejuvenation. Intervention 1: This study will be conducted as a split-hand randomized clinical trial. In each participant, both hands will be treated with ablative fractional carbon dioxide laser.First, the treatment areas will be cleansed using soap and water. A topical anesthetic cream will be applied to the skin and will be completely removed after 20 minutes.Subsequently, ablative fractional carbon dioxide laser will be performed on both hands using identical parameters:Total fluence: 1.5 joules per square centimeterPulse energy: 1.5 millijoulesDensity: 9.6Power: 30 wattsAfter laser treatment, one hand will be randomly selected to receive additional intradermal platelet-rich plasma (PRP) injection.Platelet-rich plasma (PRP) will be prepared from the patient’s peripheral venous blood using a two-step centrifugation protocol with the PRP Prime kit. The first centrifugation will be performed at 1200 revolutions per minute for 10 minutes, followed by a second centrifugation at 1600 revolutions per minute for 10 minutes.Finally, 3 milliliters of platelet-rich plasma will be injected intradermally into the selected hand.Treatment sessions will be performed at 4- to 6-week intervals for each participant. Intervention 2: This study will be conducted as a split-hand randomized clinical trial. In each participant, both hands will be treated with ablative fractional carbon dioxide laser.First, the treatment areas will be cleansed using soap and water. A topical anesthetic cream will be applied to the skin and will be completely removed after 20 minutes.Subsequently, ablative fractional carbon dioxide laser will be performed on both hands using identical parameters:Total fluence: 1.5 joules per square centimeterPulse energy: 1.5 millijoulesDensity: 9.6Power: 30 wattsAfter laser treatment, the contralateral hand will receive an intradermal injection of normal saline as placebo.Treatment sessions will be performed at 4- to 6-week intervals for each participant. Yes - There is a plan to make this available What will be shared: De-identified individual participant data, including demographic characteristics, clinical baseline data, and outcome variables, will be available upon reasonable request after publication of the study results. Facial and hand photographs collected during the study will also be available in a de-identified format with all identifying features removed or masked. Access to the data will be granted for scientifically justified requests and after approval by the corresponding investigator. Only data related to primary and secondary outcomes will be shared. Study protocol and statistical analysis plan will also be available upon request. When: Data from this study will be made available starting six months after publication of the study results in a peer-reviewed scientific journal and will remain accessible for a period of two years from the start of data availability. To whom: De-identified data from this study and related study documents will be available upon reasonable scientific request to researchers affiliated with academic, educational, and research institutions, as well as to industry-based researchers with legitimate research purposes. All requests will be reviewed and approved by the principal investigator. Identifiable patient data and participant photographs will remain strictly confidential and will not be shared under any circumstances. Conditions: Access to de-identified data and study documents will be permitted solely for scientific research purposes. Data use will be restricted to statistical analyses consistent with the approved study objectives. Any commercial use, attempts to re-identify participants, or efforts to link data back to individual identities will be strictly prohibited. Requests for data access must include a proposed analysis plan and will be subject to review and approval by the principal investigator. Data use will only be allowed within the scope of the originally stated study objectives and protocol. Where to obtain: Requests for access to study data and documents should be directed to the principal investigator. Applicants may submit their requests via the principal investigator’s email address. The contact details, including the name and email address of the principal investigator, will be made available in the final study documentation. All requests will be reviewed and considered upon scientific evaluation and approval by the principal investigator. How to obtain: Requests for access to study data and documents should be submitted in writing to the principal investigator. Upon receipt, the request will be reviewed for scientific validity and consistency with the study objectives. If necessary, the applicant may be asked to provide a detailed analysis plan and additional clarifications. The initial review process is expected to take approximately 2 to 4 weeks. Following final approval, de-identified data will be provided to the applicant. In case of rejection, the reason will be communicated in writing. Comments:
public Sanaz Zare
Tehran<, Skin Research Center, Shahid Beheshti Medical University,Shohada E Tajrish, ghods Sq, Shahrdari St
Tehran Iran (Islamic Republic of) 19839-63113 +98 21 2274 1508 sanaz.zaare@gmail.com Shahid Beheshti University of Medical Sciences scientific Sanaz Zare
Tehran<, Skin Research Center, Shahid Beheshti Medical University,Shohada E Tajrish, ghods Sq, Shahrdari St
Tehran Iran (Islamic Republic of) 19839-63113 +98 21 2274 1508 sanaz.zaare@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Mild to severe photoaging Age over 35 years Good compliance 35 years no limit Both Infection at the procedure site Pregnancy/Lactation History of scar and keloids History of doing ablative lasers and cosmetic procedures at the procedure site over the past year Hypersensivity to the anesthetic agent History of coagulation disorders and consumption anticoagulant medications Uncontrolled diabetes Uncontrolled hypertension History of congenital or acquired connective tissue disorders Fitzpatrick skin type 4-6 L81.2 Freckles Treatment - Drugs Placebo This study will be conducted as a split-hand randomized clinical trial. In each participant, both hands will be treated with ablative fractional carbon dioxide laser.First, the treatment areas will be cleansed using soap and water. A topical anesthetic cream will be applied to the skin and will be completely removed after 20 minutes.Subsequently, ablative fractional carbon dioxide laser will be performed on both hands using identical parameters:Total fluence: 1.5 joules per square centimeterPulse energy: 1.5 millijoulesDensity: 9.6Power: 30 wattsAfter laser treatment, one hand will be randomly selected to receive additional intradermal platelet-rich plasma (PRP) injection.Platelet-rich plasma (PRP) will be prepared from the patient’s peripheral venous blood using a two-step centrifugation protocol with the PRP Prime kit. The first centrifugation will be performed at 1200 revolutions per minute for 10 minutes, followed by a second centrifugation at 1600 revolutions per minute for 10 minutes.Finally, 3 milliliters of platelet-rich plasma will be injected intradermally into the selected hand.Treatment sessions will be performed at 4- to 6-week intervals for each participant. This study will be conducted as a split-hand randomized clinical trial. In each participant, both hands will be treated with ablative fractional carbon dioxide laser.First, the treatment areas will be cleansed using soap and water. A topical anesthetic cream will be applied to the skin and will be completely removed after 20 minutes.Subsequently, ablative fractional carbon dioxide laser will be performed on both hands using identical parameters:Total fluence: 1.5 joules per square centimeterPulse energy: 1.5 millijoulesDensity: 9.6Power: 30 wattsAfter laser treatment, the contralateral hand will receive an intradermal injection of normal saline as placebo.Treatment sessions will be performed at 4- to 6-week intervals for each participant. Improvement in overall hand rejuvenation, assessed by change in overall hand appearance score one month after the final treatment session, evaluated by two blinded dermatologists using standardized clinical photographs. Timepoint: One month after the final session of CO₂ laser and PRP treatment. Method of measurement: At the end of the study, standardized clinical photographs are evaluated by two independent blinded dermatologists. Improvement is recorded as percentage change in overall hand appearance (0% = no improvement, 1–25% = mild, 26–50% = moderate, 51–75% = marked, and 76–100% = excellent improvement). Improvement in hand pigmentation. Timepoint: One month after the final treatment session. Method of measurement: Changes in hand pigmentation are assessed using standardized clinical photographs evaluated by two blinded dermatologists, and the percentage of improvement compared to baseline is recorded. Improvement in hand wrinkles. Timepoint: One month after the final treatment session. Method of measurement: Wrinkle severity is evaluated by two independent blinded dermatologists using standardized photographs, and improvement is recorded as percentage reduction compared to baseline. Improvement in hand skin texture. Timepoint: One month after the final treatment session. Method of measurement: Skin texture improvement is evaluated using standardized clinical photographs by two independent blinded dermatologists. Improvement is recorded as percentage change on a 0–100% scale (0% = no improvement, 100% = maximum improvement). Patient satisfaction with treatment. Timepoint: One month after the final treatment session. Method of measurement: Patient satisfaction with treatment outcome is assessed using a percentage-based scale from 0 to 100%, where 0% indicates no satisfaction and 100% indicates complete satisfaction. Incidence of treatment-related adverse effects. Timepoint: During treatment sessions and up to one month after the final session. Method of measurement: Treatment-related adverse effects including pain, erythema, edema, burning sensation, hyperpigmentation, hypopigmentation, infection, or scarring are recorded based on clinical examination and patient reports. Shahid Beheshti University of Medical Sciences Approved 2024-08-14 Skin Research Center, Shahid Beheshti University of Medical Sciences Skin Research Center, Shahid Beheshti University of Medical Sciences shohadae tajrish hospital ghods square shahrdari street Tehran Tehran Iran (Islamic Republic of)