Evaluation of a platelet-rich topical formulation in the treatment of hand eczema: A pilot clinical trial study

To evaluate the effectiveness and safety of a platelet-rich topical formulation (PRP) for the treatment of hand eczema

A non-randomized controlled pilot clinical trial with parallel groups, double-blinded, conducted on 80 patients (40 participants per group).

This study will be conducted at Dr. Torabizadeh’s Clinic and Dr. Saki’s Laboratory in Ahvaz, Iran. Eligible patients will be screened at Dr. Torabizadeh’s Clinic and will be enrolled in the study using a non-randomized method. They will subsequently undergo examination, treatment, and follow-up at the clinic. The platelet-rich plasma (PRP)-enriched topical formulation will be prepared according to the study protocol under sterile conditions at Dr. Saki’s Laboratory and then transferred to the clinic for patient treatment. The study will be conducted in a double-blind manner.

Inclusion criteria: 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, Exclusion criteria: 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

Intervention Group: Participants will receive an autologous topical formulation containing PRP and albumin. PRP will be prepared by two-step centrifugation, combined with albumin, and applied once daily for 7–10 days. Control Group: Participants will receive a placebo base cream without PRP or albumin, identical in appearance and application method, once daily for 7–10 days.

Hand Eczema Severity Index (HECSI) Score

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.