Hair TransplantationNCT04472715
Hair Transplantation in Cicatricial Alopecia
A study testing follicular unit extarcation and platelet rich plasma in people with Hair Transplantation and Cicatricial Alopecia, run by Alexandria University at 1 site in Egypt.
Trial summary
follicular unit extraction as a method of hair transplantation in cicatricial alopecia Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hair Transplantation, Cicatricial Alopecia
- What is being tested?
- follicular unit extarcation and platelet rich plasma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2020to 5 Dec 2020
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Patients with unacceptable visible scarring alopecia.
- Adequate donor area.
- patient free of signs of disease activity evidenced by trichoscopy.
- Patients having inadequate laxity for a strip excision (too tight skin).
- When previous scars of strip surgeries make further strips impossible.
Who cannot join
- • Inadequate donor area.
- Signs of active disease or infection.
- Patient who is not willing for long sessions for several hours or multiple sessions as needed due to the slowness of the process
- Contraindications for surgical procedure as bleeding tendency.
- Contraindications for PRP as (cardiovascular, autoimmune disorders, hematological disorders and neoplasms).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EVALUATION OF THE EFFICACY OF FOLLICULAR UNIT EXTRACTION VERSUS FOLLICULAR UNIT EXTRACTION WITH PLATELETS RICH PLASMA IN TREATMENT OF CICATRICAL ALOPECIA
follicular unit extraction as a method of hair transplantation in cicatricial alopecia
Read the detailed description
The study will include 20 patients with cicatrical alopecia.Patients will be randomly assigned into two groups:Group (A):include ten patients will undergo (FUE) alone.
Group (B): include ten patients will undergo(FUE) and (PRP).3-Surgical technique:
- Preoperative Investigations including complete blood count, coagulation profile and hepatitis viral markers. 1-Group(A): will undergo (FUE)
- Washing the scalp with antiseptic shampoo before the procedure.
- Tumuscentanaesthesia:The donor area is anesthetized with a lidocaine 1% solution diluted with 20 cc saline in addition to adrenaline.
- Creation of micropunches(0.7-1 mm) using micromotor.
- After removal of the punch,the follicular unit is extracted with Jweler's forceps.
- Extracted grafts are then placed on chilled saline gauze for maximum four hours until ready for transplantation.
- The recipient area is prepared with rectangular scalpel blades 1mm or hypodermic blades 0.9 mm.
- Implantation using fine tipped jweler's forceps.
- Finally, receptor and donor areas will be softly cleansed with saline and crepe bandage is applied. 2-Group (B): FUE+PRP
- The same procedure will be done but grafts will be placed in Prp solution.
- Prp session one week before transplantation then monthly for 3 monthes after (FUE).
- Preparation of PRP
- 10 cc blood will be aspirated in test tube contained a modified solution of anticoagulant,called acid-citrate-dextrose type (ACDA), in which the physiological pH will reached to preserve the platelet integrity.
- The first spin of whole blood sample will be at 2500 rpm for 4 minutes
- The second spin at 4000 for 20 minutes for obtained plasma.
- Platelets are separated as a pellet at the bottom of the tube from platelet-poor plasma (PPP) above. The platelet-rich pellet is resuspended in remaining amount of plasma. The resulting suspension is used as PRP.
- Prp is injected in the recipient area. 4-Follow up:
- Follow up clinically by digital photographs and trichoscopy 1 week after operation, after 3 months and after 6 months.
- Conditions
- Hair Transplantation, Cicatricial Alopecia
- Being tested
- follicular unit extarcation and platelet rich plasma
- Keywords
- hair loss, follicuular unit extraction, platelet rich plasma
- 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 extarcation and platelet rich plasmaProcedure or surgery
hair transplantation procedure
| Study group | Role | What they receive |
|---|---|---|
| follicular unit extraction | Experimental | extraction of hair follicle unit from donar area and tranplant it into recepient bald area Receives: Procedure: follicular unit extarcation and platelet rich plasma |
| foolicular unit extraction and platelet rich plasma | Experimental | the same procedure mentioned above coupled with session of platelet rich plasma before and after transplantation Receives: Procedure: follicular unit extarcation and platelet rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
hair regrowth
transplanted hair develop int new hair growth in bald area
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start5 Jan 2020
- Primary completion5 Dec 2020
- Study completion5 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair TransplantationStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marwa eldeeb, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472715
- Sponsor's protocol ID
- 00007555
- Status last verified
- Jul 2021
- First submitted
- 12 Jul 2020
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE EFFICACY OF FOLLICULAR UNIT EXTRACTION VERSUS FOLLICULAR UNIT EXTRACTION WITH PLATELETS RICH PLASMA IN TREATMENT OF CICATRICAL ALOPECIA
- ClinicalTrials.gov ID
- NCT04472715
- Acronym / sponsor ID
- 00007555
- Conditions
- Hair Transplantation, Cicatricial Alopecia
- Keywords
- hair loss, follicuular unit extraction, platelet rich plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 5 Dec 2020 (actual)
- Study completion
- 5 Dec 2020 (actual)
- First posted
- 15 Jul 2020 (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.
follicular unit extraction as a method of hair transplantation in cicatricial alopecia
Detailed description
The study will include 20 patients with cicatrical alopecia.Patients will be randomly assigned into two groups:Group (A):include ten patients will undergo (FUE) alone.
Group (B): include ten patients will undergo(FUE) and (PRP).3-Surgical technique:
- Preoperative Investigations including complete blood count, coagulation profile and hepatitis viral markers. 1-Group(A): will undergo (FUE)
- Washing the scalp with antiseptic shampoo before the procedure.
- Tumuscentanaesthesia:The donor area is anesthetized with a lidocaine 1% solution diluted with 20 cc saline in addition to adrenaline.
- Creation of micropunches(0.7-1 mm) using micromotor.
- After removal of the punch,the follicular unit is extracted with Jweler's forceps.
- Extracted grafts are then placed on chilled saline gauze for maximum four hours until ready for transplantation.
- The recipient area is prepared with rectangular scalpel blades 1mm or hypodermic blades 0.9 mm.
- Implantation using fine tipped jweler's forceps.
- Finally, receptor and donor areas will be softly cleansed with saline and crepe bandage is applied. 2-Group (B): FUE+PRP
- The same procedure will be done but grafts will be placed in Prp solution.
- Prp session one week before transplantation then monthly for 3 monthes after (FUE).
- Preparation of PRP
- 10 cc blood will be aspirated in test tube contained a modified solution of anticoagulant,called acid-citrate-dextrose type (ACDA), in which the physiological pH will reached to preserve the platelet integrity.
- The first spin of whole blood sample will be at 2500 rpm for 4 minutes
- The second spin at 4000 for 20 minutes for obtained plasma.
- Platelets are separated as a pellet at the bottom of the tube from platelet-poor plasma (PPP) above. The platelet-rich pellet is resuspended in remaining amount of plasma. The resulting suspension is used as PRP.
- Prp is injected in the recipient area. 4-Follow up:
- Follow up clinically by digital photographs and trichoscopy 1 week after operation, after 3 months and after 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| follicular unit extraction | Experimental | Procedure: follicular unit extarcation and platelet rich plasmaextraction of hair follicle unit from donar area and tranplant it into recepient bald area |
| foolicular unit extraction and platelet rich plasma | Experimental | Procedure: follicular unit extarcation and platelet rich plasmathe same procedure mentioned above coupled with session of platelet rich plasma before and after transplantation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Patients with unacceptable visible scarring alopecia.
Key exclusion criteria (5 listed)
- • Inadequate donor area.
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 extarcation and platelet rich plasmahair transplantation procedure | Procedure or surgery | follicular unit extraction, foolicular unit extraction and platelet rich plasma |
Primary outcome
hair regrowth
Time frame: 6 months
transplanted hair develop int new hair growth in bald area
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
Related trials for Hair Transplantation
Not yet recruiting
Evidence-Based Integrated Protocol to Maximize Hair Follicle Survival in Follicular Unit Extraction (FUE)
Androgenetic Alopecia, Cicatricial Alopecia
Not yet recruiting
The Role of Gut and Skin Microbiota in Alopecia Areata
Alopecia Areata, Fecal Microbiota Transplantation (FMT)
RecruitingPhase 2
Evaluation of Microbiota Transplant Therapy in Patients With Alopecia Areata
Alopecia Areata, Alopecia Totalis
Recruiting
A Study on Scalp Health and Integrated Scalp Management Protocols for Hair Transplant Patients
Hair Transplantation, Seborrheic Dermatitis
Not yet recruiting
Comparison Between Platelet Rich Plasma and Nanofat as an Adjuvant Therapy in HairTransplantation
Androgenic Alopecia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing follicular unit extarcation and platelet rich plasma in people with Hair Transplantation and Cicatricial Alopecia, run by Alexandria University at 1 site in Egypt.
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 5 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: finished, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hair regrowth (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2021.