Clinical trial of safety and effectiveness of subcutaneous injection of placenta Growth factors in the treatment of androgenetic alopecia

Investigating the safety and effectiveness of human placenta growth factors' injection in the treatment of androgenic alopecia compared to the placebo group

A phase 1-2 double blinded, randomized, controlled clinical trial with 30 patients. Randomization is in simple form.

In this study, 30 patients referred to Razi Hospital in Tehran who meet the inclusion criteria and do not meet the exclusion criteria are evaluated. After obtaining informed consent from the patient, the questionnaire will be completed by the physician. Before starting the treatment and during the follow-up sessions, the number of hairs in the same area is counted using trichoscopy. Patients are treated with drugs or placebo in two groups. The physician, the patient and the evaluator will not know the type of intervention. In total, patients will be treated for 5 sessions. Injections are done every 2 weeks and the patient will return for follow-up at 0, 2, 4, 6, 8, 12 and 24 weeks.

Inclusion criteria: Androgenic alopecia, male aged 18 to 50 years, Norwood Hamilton grading 2 to 5. Exclusion criteria: Patients with two or more hair loss diagnoses, hair loss treatment during the last 3 months, patients undergoing radiotherapy and chemotherapy, immunosuppressive drugs or corticosteroids during 4 weeks before treatment

Intervention group: Subcutaneous injection of a solution containing growth factors obtained from the human placenta. Placental growth factors of 1.5 mg/ml, 3 ml per session, and 5 times at an interval of 2 weeks are injected into the patients. The placental growth factors is obtained by chemically and mechanically digestion in a clean room. Control group: subcutaneous injection of normal saline, 5 times with two-week intervals

Primary outcome: side effects Secondary outcome: hair density

The randomization method is simple. For 30 patients, 30 interventions including 15 drugs and 15 placebos are considered and a code is defined for each intervention. Then for each patient based on the table of random numbers, a code that may be drug or placebo is selected. The drug or placebo is sent to the physician in a disguised form and the physician performs the injection based on the assigned code.

In this study, patients, researchers, physician, nurse and outcome evaluator are blinded until the end of the study. For this purpose, a code is assigned to the drug or placebo, and based on the table of random numbers, a code is selected and the drug or placebo is sent to the physician in a covered form with a code. The physician administers the injection to the patient. The patient's medical record is defined as a code, and the patient and the evaluator will not know the type of medicine.

Information on the main outcome

The access period starts 6 months after the results are published

Researchers working in academic and scientific institutions

Scientific research

Amir Bajouri bajouri.md@gmail.com

The request is sent through the official email of the university, mentioning the recipient's information and the purpose of the request, and after checking the correctness of the information sent, the files are provided to the requester.