A single-center randomized controlled clinical trial of platelet-rich plasma (PRP) in the treatment of female vulvar lichen sclerosus

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: Control group:Mometasone furoate cream (0.1%), usage: 1st month: 1 time/day, 5 days/week, 2 days off per week; 2nd month: 1 time/every other day; 3rd month: 2 times/week; the application area needs to cover 0.5cm outside the boundary of the affected skin lesion.;Experimental group:Platelet‐rich plasma preparation: Collect the patient's whole blood in a disposable heparin sodium collection tube with a volume of 20 ml. Use a blood component centrifuge to separate the patient's own platelet‐rich plasma. Prepare 1 unit for one treatment use. The above process needs to be repeated for each treatment. Injection therapy with platelet‐rich plasma: Perform local subcutaneous injection of platelet‐rich plasma. The injection dose is 10 ml at one time. The treatment interval is generally 4 weeks, and the number of treatments is 4 times. a Before treatment, routinely prepare the skin and disinfect it, apply 1% lidocaine cream for local anesthesia for 30‐40 minutes, and cover with a plastic film for sealing; b The treatment area should include the visible white patches and the 0.5 cm range at the edge, and strictly avoid the urethral opening. The injection operation process: After local disinfection, use a micro needle to evenly inject the platelet‐rich plasma into the superficial layer of the dermis; the injection depth is controlled at 0.8‐1.2 mm (dermal layer), and the drug administration should be done at a uniform speed. The spacing between each injection point is approximately 0.5‐1 cm, with 40‐50 injection points. Avoid drug accumulation; during treatment, observe: Observe the skin reaction at any time. If local whitening or excessive elevation occurs, promptly adjust the injection dose and depth to reduce tissue pressure. All steps completed are recorded as one treatment co CONDITION: Lichen sclerosus of female vulva PRIMARY OUTCOME: Skin lesion area LSA;Investigator objective rating: GOS;Patient subjective score: GSS;Quality of life evaluation: QOL;Dermoscopy evaluation index;Recurrence rate; INCLUSION CRITERIA: 1. Female patients aged 20 to 65 (inclusive); 2. Have typical clinical manifestations and be diagnosed as vulvar lichen sclerosus through skin histopathological examination (refer to the Chinese expert consensus on the clinical diagnosis and treatment of vulvar lichen sclerosus in women, 2021 edition) 3. Voluntarily participate in this study and sign the informed consent form.
Epistemonikos ID: 520aa4df4c0061a8e115c9b51201fb750e3d8a6d
First added on: Oct 08, 2026