Clinical trial NCT06145672: Treatment of Alopecic Scars by Follicular Unit Extraction Hair Transplantation
Official title: Definitive Treatment of Alopecic Scars by Follicular Unit Extraction Hair Transplantation, Randomized Prospective Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alopecia Scar
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To hide alopecic scars with some hairs harvested as FUs at the back of the scalp under local anaesthesia without leaving any residual deformity or adding more scars to the donor area and implant it in the non-hairy scars.
Primary purpose: TREATMENT

Brief summary: This study aim: is to completely hide the alopecic scars in a way that it will not be visible.

Detailed description: Practicing scar revision, there is an increasing demand for almost complete reconstruction and camouflaging scars in hairy areas rather than scars in non-hairy skin. Scar revision rendered insufficient reconstructive tool in such cases. Whatever a Plastic surgeon pay efforts in alopecic scars rejuvenation and reconstruction, it is still apparent and noticeable. One of the best surgical techniques to camouflage an alopecic scar is hair transplantation. FUE is the state-of-the-art technique for hair transplantation.

In the field of hair restoration, there has been a significant increase in demand with patients for facial hair transplantation procedures. Modern techniques in hair transplantation is based on follicular unit extraction and implantation, in which follicular units are the exclusive structures used as hair grafts allow for facial hair transplantation and for the attainment of natural-appearing results. Facial hair transplantation is a subspecialty within hair restoration with many gratifying benefits for the patients as well as for the hair restoration surgeon. Adapting these advanced techniques into a hair restoration practice allows a surgeon to offer their patients these procedures and provides an expanded artistic element to a hair restoration surgeon's practice. The art and science of hair transplantation have come a long way since its introduction in 1959. Both the technique and instruments have been greatly improved, thus offering the patient an excellent cosmetic result that will last a lifetime.

Eligibility criteria: Inclusion Criteria:

* small scalp alopecic scars.
* post traumatic alopecic beard scars
* post traumatic alopecic moustache scars.
* post traumatic alopecic scalp scars.
* post traumatic alopecic eyebrow scars.
* post burn small alopecic scars.
* mature scars.
* controlled infective scars.

Exclusion Criteria:

* large alopecic scars
* post burn alaopecic scar
* uncontrolled active scar
* male pattern baldness
* female pattern baldness

Primary outcomes:
measure: evaluating post operative pain using questionnaire
timeFrame: 6 Month - 1 year
measure: evaluating post operative complications
timeFrame: 6 Month - 1 year
measure: donor and recipient site assessment
timeFrame: 6 Month - 1 year
Secondary outcomes:
measure: Follicular unit growth monitoring
timeFrame: monthly up to 1 year
measure: platlet rich plasma injection for FU growth
timeFrame: every 2 weeks up to 6 months
measure: number of hairs in each hair follicle
timeFrame: every 2 weeks up to 3months
Other outcomes:
Locations:
Study officials:
affiliation: Department of Plastic Surgery,
name: wael saadeldeen saadeldin, MD
role: STUDY_CHAIR
References:
citation: Jimenez F, Alam M, Vogel JE, Avram M. Hair transplantation: Basic overview. J Am Acad Dermatol. 2021 Oct;85(4):803-814. doi: 10.1016/j.jaad.2021.03.124. Epub 2021 Apr 24.
citation: Bared A. Beard Hair Transplantation. Facial Plast Surg Clin North Am. 2020 May;28(2):237-241. doi: 10.1016/j.fsc.2020.01.010.
citation: Pinski JB. Hair transplantation and bald-scalp reduction. Dermatol Clin. 1991 Jan;9(1):151-68.
citation: Barreto OC. [Hair transplantation. Past, present, and future]. Acta Med Port. 1998 Mar;11(3):283-5. Portuguese.
citation: Bernstein RM, Rassman WR. The logic of follicular unit transplantation. Dermatol Clin. 1999 Apr;17(2):277-95, viii; discussion 296. doi: 10.1016/s0733-8635(05)70087-5.
citation: Bernstein RM, Rassman WR. Follicular transplantation. Patient evaluation and surgical planning. Dermatol Surg. 1997 Sep;23(9):771-84; discussion 801-5.
citation: Chen L, Wang B, Liu X, Yang J, Jiang W. Comparison of 2 Incisional Methods in Hair Transplantation. J Craniofac Surg. 2023 Jul-Aug 01;34(5):e499-e501. doi: 10.1097/SCS.0000000000009372. Epub 2023 Jun 12.