Androgenetic AlopeciaNCT07155408
Topical Rifamycin SV for Wound Healing After Sapphire FUE Hair Transplantation
A study testing Povidone-Iodine 10% and Rifamycin SV Sodium in people with Androgenetic Alopecia and Wound Healing, run by Elif Asena KANTARCI at 1 site in Turkey (Türkiye).
Trial summary
This prospective, parallel-group controlled clinical study evaluated whether a single topical rifamycin SV protocol added to standardized care after sapphire follicular unit extraction (FUE) was associated with earlier recorded wound healing. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Androgenetic Alopecia, Wound Healing
- What is being tested?
- Povidone-Iodine 10% and Rifamycin SV Sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Dec 2021to 22 Jun 2022
- 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 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male participants older than 20 years
- Scheduled for a first hair transplantation session
- Deemed medically fit for the procedure
- Provided written informed consent
Who cannot join
- Diabetes or another chronic or systemic condition that could affect wound healing
- Heart failure or kidney failure
- Communicable disease
- Scalp disorder
- Recent antibiotic use
- Planned second hair transplantation session
- Absence of a medical fitness report
- Medication, antibiotic, rifamycin, or topical-solution allergy relevant to the protocol
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bahcesehir University, School of Health Sciences, Department of Nursing
Istanbul, Besiktas, 34353
About this study
Official title: Topical Rifamycin SV After Sapphire FUE: Accelerated Wound Healing and Anticipatory and Preventive Nursing Care
This prospective, parallel-group controlled clinical study evaluated whether a single topical rifamycin SV protocol added to standardized care after sapphire follicular unit extraction (FUE) was associated with earlier recorded wound healing. One hundred candidates were assessed, and 70 men were individually allocated 1:1 using MedCalc. Five participants were excluded after allocation but before surgery and before receiving the assigned intervention because final preoperative serological testing met prespecified exclusion criteria. The analyzed sample comprised 34 participants in the rifamycin SV group and 31 in the control group. Healing was assessed through postoperative Day 14 using scheduled clinical review and serial photographs. Infection and hypersensitivity were monitored as safety outcomes.
Read the detailed description
All procedures were performed in one private hair transplantation clinic between December 2021 and May 2022 using the same sapphire FUE technique, clinical team, equipment, antisepsis, systemic medications, care products, washing instructions, and follow-up protocol. MedCalc was run separately for each consented participant to generate an individual 1:1 assignment. The clinical nurse-investigator generated and implemented allocation and was not masked; allocation was not concealed from this investigator. Participants and the two physicians who jointly assessed clinical healing were unaware of group assignment.
Both groups received approximately 50 mL of 10% povidone-iodine on the donor and recipient areas before surgery, followed by normal saline cleansing. The experimental group then received one ampule of RIF containing rifamycin SV sodium 125 mg/1.5 mL. The solution was used topically and off-label and was not injected. It was divided equally: 0.75 mL was applied dropwise to the donor surface after graft harvesting and before dressing, and 0.75 mL was applied to the recipient surface after graft implantation was completed. The control group received normal saline spray at the corresponding donor- and recipient-area time points.
The primary clinical outcome was the earliest interval in which the overall wound course was judged, by masked physician consensus and serial photographs, to have entered one of three recorded healing categories: 1-3 days, greater than 3-7 days, or greater than 7-14 days. The assessment integrated wound-bed and surrounding-skin appearance, bleeding or abnormal exudate, erythema, edema, tenderness, crusting, and spontaneous crust separation. The categories were not validated specifically for FUE and did not directly measure exact time to complete epithelialization. Persistent crusting on Day 14 was supportive; erythema on Day 7 and tenderness on Day 14 were exploratory. Clinically confirmed infection and rifamycin-related hypersensitivity were monitored as safety outcomes. All analyzed participants received ciprofloxacin 500 mg twice daily for 7 days, so the study was not designed to determine an independent anti-infective effect of topical rifamycin SV.
- Conditions
- Androgenetic Alopecia, Wound Healing
- Being tested
- Povidone-Iodine 10%, Rifamycin SV Sodium
- Keywords
- Androgenetic Alopecia, Povidone-Iodine, Wound Healing, Scalp Antisepsis, Postoperative Care, Hair Transplantation, Rifamycin SV, Follicular Unit Extraction, Dermatology Nursing
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-Iodine 10%Drug
Preoperative skin antisepsis performed with 10% povidone-iodine solution according to standard surgical preparation guidelines before hair transplantation.
Rifamycin SV SodiumDrug
Also called RIF 125 mg/1.5 mL
One complete ampule containing rifamycin SV sodium 125 mg/1.5 mL was drawn into a syringe and applied topically and off-label; it was not injected. The clinical nurse-investigator applied 0.75 mL dropwise to the donor surface after graft harvesting and before dressing and 0.75 mL to the recipient surface after graft implantation was completed. Each application was distributed with separately applied normal saline spray.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Control | Active comparator | Participants received the standardized sapphire FUE protocol, including 10% povidone-iodine scalp antisepsis before surgery. Normal saline spray was applied to the donor area after graft harvesting and before dressing and to the recipient area after graft implantation was completed. Participants received the same postoperative nursing care, systemic medications, care products, washing instructions, and follow-up schedule as the experimental group. Receives: Drug: Povidone-Iodine 10% |
| Topical Rifamycin SV | Experimental | Participants received the same standardized sapphire FUE protocol and preoperative 10% povidone-iodine scalp antisepsis as controls. One ampule of RIF containing rifamycin SV sodium 125 mg/1.5 mL was then used topically and off-label. The clinical nurse-investigator applied 0.75 mL dropwise to the donor surface after graft harvesting and before dressing and 0.75 mL to the recipient surface after graft implantation was completed. The solution was not injected. Receives: Drug: Povidone-Iodine 10%; Drug: Rifamycin SV Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recorded Early Healing Category
Each participant was assigned to the earliest interval in which the overall wound course was judged, by consensus of two masked physicians using serial clinical photographs, to have entered a healing category: 1-3 days, greater than 3-7 days, or greater than 7-14 days. Assessment integrated wound-bed and surrounding-skin appearance, bleeding or abnormal exudate, erythema, edema, tenderness, crusting, and spontaneous crust separation. These categories did not directly measure exact time to complete epithelialization.
Measured: Assessed from postoperative Day 1 through Day 14
Secondary outcomes (4)
Persistent Crusting on Postoperative Day 14
Presence of persistent crusting before planned physician-approved cleaning on postoperative Day 14, recorded as present or absent during the standardized clinical wound assessment.
Measured: Postoperative Day 14
Erythema on Postoperative Day 7
Presence of erythema on postoperative Day 7, recorded as present or absent during the standardized clinical wound assessment. Erythema alone did not establish clinical infection.
Measured: Postoperative Day 7
Tenderness on Postoperative Day 14
Presence of tenderness on postoperative Day 14, recorded as present or absent during the standardized clinical wound assessment.
Measured: Postoperative Day 14
Clinical Infection and Rifamycin-Related Hypersensitivity
Clinically confirmed infection was assessed based on progression or persistence together with findings such as purulent drainage, spreading inflammation, marked local heat, increasing pain, systemic findings, positive culture when obtained, or need for additional treatment. Localized or systemic hypersensitivity attributable to topical rifamycin SV was also monitored.
Measured: From intervention through postoperative Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start2 Dec 2021
- Primary completion15 May 2022
- Study completion22 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- 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
- Participants were assigned in a 1:1 ratio to two parallel groups. MedCalc was run separately for each consented participant to generate an individual assignment to topical rifamycin SV or control; allocation was not based on alternation. Five of 70 allocated participants were excluded before surgery and before receiving the assigned intervention after final preoperative serological testing met prespecified exclusion criteria.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elif Asena KANTARCI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elif Asena KANTARCI, Bahçeşehir University
- Investigators
- Fadime ÇINAR, Assoc. Prof.,PhD, Study chair, Nisantasi University, School of Health Sciences, Department of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155408
- Sponsor's protocol ID
- BAU-EAS-2025-001
- Other IDs
- E-22481095-020-1516
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Deidentified participant-level data may be made available from the corresponding author upon reasonable request, subject to ethics approval and participant confidentiality requirements. A final sharing plan has not been established.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Rifamycin SV After Sapphire FUE: Accelerated Wound Healing and Anticipatory and Preventive Nursing Care
- ClinicalTrials.gov ID
- NCT07155408
- Acronym / sponsor ID
- BAU-EAS-2025-001
- Conditions
- Androgenetic Alopecia, Wound Healing
- Keywords
- Androgenetic Alopecia, Povidone-Iodine, Wound Healing, Scalp Antisepsis, Postoperative Care, Hair Transplantation, Rifamycin SV, Follicular Unit Extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Elif Asena KANTARCIUniversity, hospital or other
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 4 Sep 2025 (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 prospective, parallel-group controlled clinical study evaluated whether a single topical rifamycin SV protocol added to standardized care after sapphire follicular unit extraction (FUE) was associated with earlier recorded wound healing. One hundred candidates were assessed, and 70 men were individually allocated 1:1 using MedCalc. Five participants were excluded after allocation but before surgery and before receiving the assigned intervention because final preoperative serological testing met prespecified exclusion criteria. The analyzed sample comprised 34 participants in the rifamycin SV group and 31 in the control group. Healing was assessed through postoperative Day 14 using scheduled clinical review and serial photographs. Infection and hypersensitivity were monitored as safety outcomes.
Detailed description
All procedures were performed in one private hair transplantation clinic between December 2021 and May 2022 using the same sapphire FUE technique, clinical team, equipment, antisepsis, systemic medications, care products, washing instructions, and follow-up protocol. MedCalc was run separately for each consented participant to generate an individual 1:1 assignment. The clinical nurse-investigator generated and implemented allocation and was not masked; allocation was not concealed from this investigator. Participants and the two physicians who jointly assessed clinical healing were unaware of group assignment.
Both groups received approximately 50 mL of 10% povidone-iodine on the donor and recipient areas before surgery, followed by normal saline cleansing. The experimental group then received one ampule of RIF containing rifamycin SV sodium 125 mg/1.5 mL. The solution was used topically and off-label and was not injected. It was divided equally: 0.75 mL was applied dropwise to the donor surface after graft harvesting and before dressing, and 0.75 mL was applied to the recipient surface after graft implantation was completed. The control group received normal saline spray at the corresponding donor- and recipient-area time points.
The primary clinical outcome was the earliest interval in which the overall wound course was judged, by masked physician consensus and serial photographs, to have entered one of three recorded healing categories: 1-3 days, greater than 3-7 days, or greater than 7-14 days. The assessment integrated wound-bed and surrounding-skin appearance, bleeding or abnormal exudate, erythema, edema, tenderness, crusting, and spontaneous crust separation. The categories were not validated specifically for FUE and did not directly measure exact time to complete epithelialization. Persistent crusting on Day 14 was supportive; erythema on Day 7 and tenderness on Day 14 were exploratory. Clinically confirmed infection and rifamycin-related hypersensitivity were monitored as safety outcomes. All analyzed participants received ciprofloxacin 500 mg twice daily for 7 days, so the study was not designed to determine an independent anti-infective effect of topical rifamycin SV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were assigned in a 1:1 ratio to two parallel groups. MedCalc was run separately for each consented participant to generate an individual assignment to topical rifamycin SV or control; allocation was not based on alternation. Five of 70 allocated participants were excluded before surgery and before receiving the assigned intervention after final preoperative serological testing met prespecified exclusion criteria.
| Arm | Type | Receives |
|---|---|---|
| Standard Care Control | Active comparator | Drug: Povidone-Iodine 10%Participants received the standardized sapphire FUE protocol, including 10% povidone-iodine scalp antisepsis before surgery. Normal saline spray was applied to the donor area after graft harvesting and before dressing and to the recipient area after graft implantation was completed. Participants received the same postoperative nursing care, systemic medications, care products, washing instructions, and follow-up schedule as the experimental group. |
| Topical Rifamycin SV | Experimental | Drug: Povidone-Iodine 10%, Drug: Rifamycin SV SodiumParticipants received the same standardized sapphire FUE protocol and preoperative 10% povidone-iodine scalp antisepsis as controls. One ampule of RIF containing rifamycin SV sodium 125 mg/1.5 mL was then used topically and off-label. The clinical nurse-investigator applied 0.75 mL dropwise to the donor surface after graft harvesting and before dressing and 0.75 mL to the recipient surface after graft implantation was completed. The solution was not injected. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male participants older than 20 years
- Scheduled for a first hair transplantation session
- Deemed medically fit for the procedure
- Provided written informed consent
Key exclusion criteria (8 listed)
- Diabetes or another chronic or systemic condition that could affect wound healing
- Heart failure or kidney failure
- Communicable disease
- Scalp disorder
- Recent antibiotic use
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 |
|---|---|---|
| Povidone-Iodine 10%Preoperative skin antisepsis performed with 10% povidone-iodine solution according to standard surgical preparation guidelines before hair transplantation. | Drug | Standard Care Control, Topical Rifamycin SV |
| Rifamycin SV SodiumAlso: RIF 125 mg/1.5 mLOne complete ampule containing rifamycin SV sodium 125 mg/1.5 mL was drawn into a syringe and applied topically and off-label; it was not injected. The clinical nurse-investigator applied 0.75 mL dropwise to the donor surface after graft harvesting and before dressing and 0.75 mL to the recipient surface after graft implantation was completed. Each application was distributed with separately applied normal saline spray. | Drug | Topical Rifamycin SV |
Primary outcome
Recorded Early Healing Category
Time frame: Assessed from postoperative Day 1 through Day 14
Each participant was assigned to the earliest interval in which the overall wound course was judged, by consensus of two masked physicians using serial clinical photographs, to have entered a healing category: 1-3 days, greater than 3-7 days, or greater than 7-14 days. Assessment integrated wound-bed and surrounding-skin appearance, bleeding or abnormal exudate, erythema, edema, tenderness, crusting, and spontaneous crust separation. These categories did not directly measure exact time to complete epithelialization.
4 secondary outcomes
Persistent Crusting on Postoperative Day 14
Time frame: Postoperative Day 14
Erythema on Postoperative Day 7
Time frame: Postoperative Day 7
Tenderness on Postoperative Day 14
Time frame: Postoperative Day 14
Clinical Infection and Rifamycin-Related Hypersensitivity
Time frame: From intervention through postoperative Day 14
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 15 Sep 2026.
- Individual participant dataSharing planned: Undecided. Deidentified participant-level data may be made available from the corresponding author upon reasonable request, subject to ethics approval and participant confidentiality requirements. A final sharing plan has not been established.
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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.
Fadime ÇINAR, Assoc. Prof.,PhD study chair
Nisantasi University, School of Health Sciences, Department of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Povidone-Iodine 10% and Rifamycin SV Sodium in people with Androgenetic Alopecia and Wound Healing, run by Elif Asena KANTARCI at 1 site in Turkey (Türkiye).
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 4 inclusion and 8 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 15 Sep 2026. 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 Turkey (Türkiye). 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?
Recorded Early Healing Category (time frame: Assessed from postoperative Day 1 through Day 14). 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 15 Sep 2026.