An interventional study of Integrated Evidence-Based FUE Protocol and Standard FUE Practice in Androgenetic Alopecia and Cicatricial Alopecia, sponsored by Assiut University. Not yet recruiting. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
Follicular unit extraction (FUE) is a widely used surgical technique for hair restoration, yet hair follicle survival rates vary depending on surgical instrumentation, graft handling, and perioperative care.
The purpose of this clinical trial is to evaluate whether an evidence-based, integrated perioperative protocol maximizes hair follicle graft survival compared with standard departmental practice in male patients undergoing FUE for androgenetic alopecia or localized scarring alopecia.
Participants will be randomly assigned to one of two groups:
Follicle survival and hair density will be tracked using digital trichoscopy in pre-marked 1×1 cm reference scalp areas over a 12-month follow-up period. Investigators will also assess intraoperative follicular transection rates, procedural complications, and patient satisfaction between the two groups.
Exclusion Criteria:
Participants undergo follicular unit extraction (FUE) using a standardized, evidence-based perioperative workflow. This includes algorithmic punch selection (0.8-1.0 mm) based on donor hair caliber and scalp characteristics, pre-set extraction depth (2.5-4 mm) and natural exit angulation, atraumatic microsurgical forceps handling, chilled holding solution maintained at 4 °C, strict time-stamping with graft out-of-body time targeted to ≤2-4 hours, and standardized recipient site implantation density (30-50 FU/cm²).
Procedure: Integrated Evidence-Based FUE Protocol
Participants undergo follicular unit extraction (FUE) according to routine departmental practice, where punch selection, harvesting depth, extraction angle, and graft handling/storage procedures are performed according to the operating surgeon's standard, non-standardized routine. All perioperative medications and post-operative care instructions remain identical to the experimental arm.
Procedure: Standard FUE Practice
A standardized perioperative FUE protocol consisting of: algorithmic micromotor punch selection (0.8-1.0 mm diameter; sharp, blunt, or serrated/trumpet-shaped) based on hair caliber, curl, and scalp laxity; pre-set extraction depth (2.5-4.0 mm) aligned with natural hair exit angles; atraumatic graft extraction using Foerster-type microsurgical forceps; graft preservation in a chilled holding solution maintained at 4 °C; strict monitoring targeting total out-of-body time to ≤2-4 hours; and standardized recipient site creation and implantation (30-50 FU/cm²) via micro-blades or Choi-type implanter pens.
Conventional follicular unit extraction performed according to routine departmental practice, wherein extraction punch selection, harvesting depth, incision angles, graft holding conditions, and out-of-body handling times are determined based on the operating surgeon's individual routine without standardized protocolized constraints. Postoperative care and medical regimens remain identical to the experimental arm.
Hair Follicle Survival Rate
Hair follicle graft survival rate assessed within the pre-marked 1×1 cm recipient study reference boxes using digital trichoscopy. The survival percentage is calculated using the following formula: \[(Number of follicles counted at 12 months - baseline follicle count in recipient area) ÷ (Number of grafts transplanted into the reference box)\] × 100%.
Time frame: 12 months postoperatively
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Assiut University