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IRCT20251122068073N2 IRCT 2026-08-21 Ahvaz University of Medical Sciences Evaluation of a platelet-rich topical formulation in the treatment of hand eczema Evaluation of a platelet-rich topical formulation in the treatment of hand eczema: A pilot clinical trial study 2026-01-04 anticipated 80 Complete https://irct.ir/trial/88178 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: This study will be conducted using a double-blind design. Participants will be informed during the informed consent process that the study includes two groups (a topical PRP-albumin formulation and a placebo base cream) and that they will be randomly assigned to one of the groups; however, they will remain unaware of their treatment allocation. The placebo will be identical to the intervention in appearance, color, consistency, packaging, and method of application. The randomization sequence will be generated using the Sealed Envelope online system, and allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes. Investigators, outcome assessors, and the statistical analyst will remain blinded to treatment allocation until completion of the data analysis. N/A eczema. Intervention 1: Intervention Group: Participants in the intervention group will receive an autologous topical formulation containing platelet-rich plasma (PRP) and autologous albumin. PRP will be prepared using a two-step centrifugation method and mixed at a ratio of 2/3 PRP to 1/3 autologous albumin. The formulation will be applied topically once daily for 7–10 days to the affected area. Clinical assessment will be performed before and after the treatment period. Intervention 2: Control group: Participants in the control group will receive a placebo base cream without PRP or albumin, identical to the intervention formulation in appearance, consistency, and method of application. The placebo cream will be applied topically once daily for 7–10 days to the affected area. Clinical assessment will be performed before and after the treatment period. 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 A decision cannot be made until the work and article are written and completed.
public Mehdi Torabizadeh
Arad Medical Complex, East 17th Street, Kianpars
Ahvaz Iran (Islamic Republic of) 6155993706 +98 916 113 4212 drtorabizadeh@ajums.ac.ir Ahvaz University of Medical Sciences scientific Mehdi Torabizadeh
Arad Medical Complex, East 17th Street, Kianpars
Ahvaz Iran (Islamic Republic of) 6155993706 +98 916 113 4212 drtorabizadeh@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Clinical diagnosis of eczema (atopic dermatitis) confirmed by a dermatologist Age between 18 and 65 years Mild to moderate disease severity based on validated clinical scoring systems Written informed consent to participate in the study 18 years no limit Both Presence of other inflammatory or autoimmune skin diseases Pregnancy or breastfeeding Severe systemic diseases (hepatic, renal, cardiac disorders, or malignancies) Active skin infection at the study site L30.9 Dermatitis, unspecified Treatment - Drugs Treatment - Drugs Intervention Group: Participants in the intervention group will receive an autologous topical formulation containing platelet-rich plasma (PRP) and autologous albumin. PRP will be prepared using a two-step centrifugation method and mixed at a ratio of 2/3 PRP to 1/3 autologous albumin. The formulation will be applied topically once daily for 7–10 days to the affected area. Clinical assessment will be performed before and after the treatment period. Control group: Participants in the control group will receive a placebo base cream without PRP or albumin, identical to the intervention formulation in appearance, consistency, and method of application. The placebo cream will be applied topically once daily for 7–10 days to the affected area. Clinical assessment will be performed before and after the treatment period. Hand Eczema Severity Index (HECSI) Score. Timepoint: The assessment is once before the intervention and once after the formulation is consumed. Method of measurement: The severity of hand eczema is measured using the Hand Eczema Severity Index. In this index, clinical symptoms including redness, scaling, vesicles, fissures, edema, and papules in different areas of the hand (palms, back of the hand, and fingers) are assessed by a physician and scored based on the severity of each symptom and the extent of involvement. Ahvaz University of Medical Sciences Approved 2025-11-01 Ahvaz Jundishapur University of Medical Sciences Ethics Committee Ethics Committee Office, First Floor, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, University Campus, Golestan Ahvaz Khouzestan Iran (Islamic Republic of)