Alopecia ScarNCT06145672
Treatment of Alopecic Scars by Follicular Unit Extraction Hair Transplantation
A study testing follicular unit extraction and implantaion in people with Alopecia Scar, run by Assiut University.
Trial summary
This study aim: is to completely hide the alopecic scars in a way that it will not be visible. Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Alopecia Scar
- What is being tested?
- follicular unit extraction and implantaion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- large alopecic scars
- post burn alaopecic scar
- uncontrolled active scar
- male pattern baldness
- female pattern baldness
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Definitive Treatment of Alopecic Scars by Follicular Unit Extraction Hair Transplantation, Randomized Prospective Controlled Study
This study aim: is to completely hide the alopecic scars in a way that it will not be visible.
Read the 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.
- Conditions
- Alopecia Scar
- Being tested
- follicular unit extraction and implantaion
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follicular unit extraction and implantaionProcedure or surgery
extract hair follicles as grafts from donor area and implant them in recipient area
| Study group | Role | What they receive |
|---|---|---|
| Mature Alopecic Scars | Active comparator | Follicular Unit Extraction and implantation for Alopecic Scars in beard Follicular Unit Extraction and implantation for Alopecic Scars in scalp Follicular Unit Extraction and implantation for Alopecic Scars in eyebrow Follicular Unit Extraction and implantation for Alopecic Scars in Moustache Receives: Procedure: follicular unit extraction and implantaion |
| Immature Alopecic Scars | Experimental | Follicular Unit Extraction and implantation for Alopecic Scars in beard Follicular Unit Extraction and implantation for Alopecic Scars in scalp Follicular Unit Extraction and implantation for Alopecic Scars in eyebrow Follicular Unit Extraction and implantation for Alopecic Scars in Moustache Receives: Procedure: follicular unit extraction and implantaion |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluating post operative pain using questionnaire
assessment of post operative pain and complications using questionnaire
Measured: 6 Month - 1 year
evaluating post operative complications
assessment of post operative pain and complications using questionnaire
Measured: 6 Month - 1 year
donor and recipient site assessment
care for recipient as well as donor site using questionnaire
Measured: 6 Month - 1 year
Secondary outcomes (3)
Follicular unit growth monitoring
close monitoring for growth of FU growth
Measured: monthly up to 1 year
platlet rich plasma injection for FU growth
Measured: every 2 weeks up to 6 months
number of hairs in each hair follicle
Measured: every 2 weeks up to 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Alopecia ScarStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maged Medhat Armaneous, Assiut University
- Investigators
- wael saadeldeen saadeldin, MD, Study chair, Department of Plastic Surgery,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145672
- Sponsor's protocol ID
- Follicular Unit Extraction
- Status last verified
- Nov 2023
- First submitted
- 26 Oct 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33905785Bared A. Beard Hair Transplantation. Facial Plast Surg Clin North Am. 2020 May;28(2):237-241. doi: 10.1016/j.fsc.2020.01.010.
PubMed 32312510Pinski JB. Hair transplantation and bald-scalp reduction. Dermatol Clin. 1991 Jan;9(1):151-68.
PubMed 2022091Barreto OC. [Hair transplantation. Past, present, and future]. Acta Med Port. 1998 Mar;11(3):283-5. Portuguese.
PubMed 9741133Bernstein 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.
PubMed 10327298Bernstein RM, Rassman WR. Follicular transplantation. Patient evaluation and surgical planning. Dermatol Surg. 1997 Sep;23(9):771-84; discussion 801-5.
PubMed 9311372Chen 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.
PubMed 37307246
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Definitive Treatment of Alopecic Scars by Follicular Unit Extraction Hair Transplantation, Randomized Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT06145672
- Acronym / sponsor ID
- Follicular Unit Extraction
- Conditions
- Alopecia Scar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mature Alopecic Scars | Active comparator | Procedure: follicular unit extraction and implantaionFollicular Unit Extraction and implantation for Alopecic Scars in beard Follicular Unit Extraction and implantation for Alopecic Scars in scalp Follicular Unit Extraction and implantation for Alopecic Scars in eyebrow Follicular Unit Extraction and implantation for Alopecic Scars in Moustache |
| Immature Alopecic Scars | Experimental | Procedure: follicular unit extraction and implantaionFollicular Unit Extraction and implantation for Alopecic Scars in beard Follicular Unit Extraction and implantation for Alopecic Scars in scalp Follicular Unit Extraction and implantation for Alopecic Scars in eyebrow Follicular Unit Extraction and implantation for Alopecic Scars in Moustache |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- small scalp alopecic scars.
- post traumatic alopecic beard scars
- post traumatic alopecic moustache scars.
- post traumatic alopecic scalp scars.
- post traumatic alopecic eyebrow scars.
Key exclusion criteria (5 listed)
- large alopecic scars
- post burn alaopecic scar
- uncontrolled active scar
- male pattern baldness
- female pattern baldness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| follicular unit extraction and implantaionextract hair follicles as grafts from donor area and implant them in recipient area | Procedure or surgery | Immature Alopecic Scars, Mature Alopecic Scars |
Primary outcome
evaluating post operative pain using questionnaire
Time frame: 6 Month - 1 year
assessment of post operative pain and complications using questionnaire
evaluating post operative complications
Time frame: 6 Month - 1 year
assessment of post operative pain and complications using questionnaire
donor and recipient site assessment
Time frame: 6 Month - 1 year
care for recipient as well as donor site using questionnaire
3 secondary outcomes
Follicular unit growth monitoring
Time frame: monthly up to 1 year
platlet rich plasma injection for FU growth
Time frame: every 2 weeks up to 6 months
number of hairs in each hair follicle
Time frame: every 2 weeks up to 3months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Results publication: PubMed 33905785Jimenez 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.
- Results publication: PubMed 32312510Bared A. Beard Hair Transplantation. Facial Plast Surg Clin North Am. 2020 May;28(2):237-241. doi: 10.1016/j.fsc.2020.01.010.
- Results publication: PubMed 2022091Pinski JB. Hair transplantation and bald-scalp reduction. Dermatol Clin. 1991 Jan;9(1):151-68.
- Results publication: PubMed 9741133Barreto OC. [Hair transplantation. Past, present, and future]. Acta Med Port. 1998 Mar;11(3):283-5. Portuguese.
- Results publication: PubMed 10327298Bernstein 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.
- Results publication: PubMed 9311372Bernstein RM, Rassman WR. Follicular transplantation. Patient evaluation and surgical planning. Dermatol Surg. 1997 Sep;23(9):771-84; discussion 801-5.
- Results publication: PubMed 37307246Chen 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.
- Individual participant dataSharing planned: No
Related trials for Alopecia Scar
RecruitingPhase 2
Tirzepatide for Treatment of CCCA
Central Centrifugal Cicatricial Alopecia (CCCA)
Recruiting
1470nm Laser for the Treatment of Androgenetic Alopecia and Scarring Alopecia
Scarring Alopecia, Androgenetic Alopecia
Not yet recruiting
Evidence-Based Integrated Protocol to Maximize Hair Follicle Survival in Follicular Unit Extraction (FUE)
Androgenetic Alopecia, Cicatricial Alopecia
Recruiting
A Pilot Study of Revian Red All LED Cap as a Novel Treatment for Central Centrifugal Cicatricial Alopecia
Central Centrifugal Cicatricial Alopecia
RecruitingPhase 2
Safety and Biomarker Responses of Delgocitinib (JAK1,2,3/TYK2 Inhibitor) in Central Centrifugal Cicatricial Alopecia and Lichen Planopilaris
Central Centrifugal Cicatricial Alopecia, Lichen Planopilaris
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
wael saadeldeen saadeldin, MD study chair
Department of Plastic Surgery,
Questions about this trial
What is this clinical trial studying?
A study testing follicular unit extraction and implantaion in people with Alopecia Scar, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maged Medhat Armaneous hanna, bchelor ged (+201050092723, maged.hana200@gmail.cpm), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluating post operative pain using questionnaire (time frame: 6 Month - 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06145672, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.