Vitiligo VulgarisNCT07763262
Autologous Nanofat Injection for Treatment of Stable Vitiligo
A study testing Autologous Nanofat Injection and NB-UVB Phototherapy in people with Vitiligo Vulgaris, run by Benha University at 1 site in Egypt.
Trial summary
This randomized, split-site, within-participant controlled clinical study evaluated the efficacy and safety of a single session of autologous nanofat injection as an adjunct to narrowband ultraviolet B (NB-UVB) phototherapy in 20 adult patients with stable vitiligo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo Vulgaris
- What is being tested?
- Autologous Nanofat Injection and NB-UVB Phototherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 Mar 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Male or female patients.
- Patients with clinically diagnosed stable vitiligo.
- Presence of comparable vitiligo sites suitable for the split-site study design.
- Ability to undergo autologous nanofat harvesting and injection.
- Ability and willingness to undergo NB-UVB phototherapy three times weekly for 3 months.
- Ability to comply with study follow-up and assessment procedures.
- Provision of written informed consent.
Who cannot join
- Active or progressive vitiligo.
- Active infection or inflammation at the treatment sites.
- Significant uncontrolled systemic disease that could interfere with treatment or assessment.
- Contraindication to NB-UVB phototherapy.
- Contraindication to the nanofat harvesting or injection procedure.
- Pregnancy or breastfeeding, if this was an exclusion criterion in your protocol.
Show all 9Show fewer
- Previous treatment of the selected study sites that could interfere with assessment.
- Inability to comply with the study protocol or follow-up.
- Any condition considered by the investigator to interfere with the safety or assessment of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of The Effect of Autologous Nanofat Injection in the Treatment of Vitiligo
This randomized, split-site, within-participant controlled clinical study evaluated the efficacy and safety of a single session of autologous nanofat injection as an adjunct to narrowband ultraviolet B (NB-UVB) phototherapy in 20 adult patients with stable vitiligo. In each participant, one vitiligo site received autologous nanofat injection followed by NB-UVB phototherapy three times weekly for 3 months, while a comparable site received NB-UVB phototherapy alone. Treatment response was assessed by standardized photography performed by a blinded dermatologist, with evaluation of the onset and percentage of repigmentation, patient satisfaction, and treatment-related adverse effects.
Read the detailed description
This randomized, split-site, within-participant controlled clinical study was conducted to evaluate the efficacy and safety of a single session of autologous nanofat injection as an adjunctive treatment to narrowband ultraviolet B (NB-UVB) phototherapy in patients with stable vitiligo.
Twenty adult patients with stable vitiligo were included, with both male and female participants eligible for enrollment. Each participant served as his or her own control. Two comparable vitiligo sites were selected in each participant. One site was treated with a single session of autologous nanofat injection followed by NB-UVB phototherapy, while the other comparable site received NB-UVB phototherapy alone.
NB-UVB phototherapy was administered three times weekly for 3 months to both treatment sites according to the study protocol. The nanofat-treated site received a single session of autologous nanofat injection before the course of NB-UVB phototherapy.
Treatment response was assessed by standardized clinical examination and serial standardized digital photographs. Photographic assessments were performed by an independent dermatologist who was blinded to the treatment allocation of the sites.
The primary efficacy assessment was based on the onset and degree of repigmentation of the treated vitiligo lesions. The percentage of repigmentation was assessed by comparison with the baseline appearance and standardized photographic documentation.
Patient satisfaction with treatment was assessed during follow-up using a predefined satisfaction scale. Treatment-related adverse effects and local or systemic reactions were recorded throughout the study period.
The study was designed to determine whether adding a single session of autologous nanofat injection to NB-UVB phototherapy provided greater or faster repigmentation than NB-UVB phototherapy alone in patients with stable vitiligo.
- Conditions
- Vitiligo Vulgaris
- Being tested
- Autologous Nanofat Injection, NB-UVB Phototherapy
- Keywords
- vitiligo; Autologous nanofat; Nanofat injection; Narrowband ultraviolet B
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Nanofat InjectionProcedure or surgery
A single session of autologous nanofat injection was performed in the randomly assigned vitiligo site. Nanofat was prepared from the participant's own adipose tissue according to the study protocol and injected into the selected vitiligo lesion.
NB-UVB PhototherapyOther
Narrowband ultraviolet B (NB-UVB) phototherapy was administered to both the nanofat-treated and control sites three times weekly for 3 months according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Nanofat Injection + NB-UVB | Experimental | A single session of autologous nanofat injection was performed in the randomly assigned vitiligo site. Nanofat was prepared from the participant's own adipose tissue according to the study protocol and injected into the selected vitiligo lesion. Receives: Procedure: Autologous Nanofat Injection |
| NB-UVB Alone | Active comparator | Narrowband ultraviolet B (NB-UVB) phototherapy was administered to both the nanofat-treated and control sites three times weekly for 3 months according to the study protocol. Receives: Other: NB-UVB Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Repigmentation
Percentage of repigmentation of the treated vitiligo site compared with baseline, assessed using standardized clinical and photographic evaluation and compared between the nanofat-treated site and the NB-UVB-only control site.
Measured: Baseline to 3 months
Secondary outcomes (3)
Onset of Repigmentation
Time to onset of clinically detectable repigmentation following initiation of treatment, comparing the nanofat-treated site with the NB-UVB-only control site.
Measured: During the 3-month treatment period
Patient Satisfaction
Patient-reported satisfaction with the treatment outcome, assessed using a predefined satisfaction scale.
Measured: At the final 3-month assessment
Treatment-Related Adverse Effects
Incidence and severity of treatment-related adverse effects and local reactions associated with nanofat injection and NB-UVB phototherapy.
Measured: From treatment initiation through 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Apr 2024
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vitiligo VulgarisStudies of the same condition, open and under way.
- More trials run by Benha 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, karem Taha ibrahim khalil, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763262
- Sponsor's protocol ID
- MS 8-3-2024
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thind A, Vinay K, Mehta H, Bishnoi A, Kumaran MS, Parsad D. Whole-body and targeted narrowband ultraviolet B phototherapy effectively stabilize acral vitiligo with negligible repigmentation beyond wrists and ankles: Results from a split-body randomized controlled trial. Photodermatol Photoimmunol Photomed. 2024 Mar;40(2):e12960. doi: 10.1111/phpp.12960.
PubMed 38480997Asawanonda P, Klahan SO. Tetrahydrocurcuminoid cream plus targeted narrowband UVB phototherapy for vitiligo: a preliminary randomized controlled study. Photomed Laser Surg. 2010 Oct;28(5):679-84. doi: 10.1089/pho.2009.2637.
PubMed 20961233Esmat SM, El-Mofty M, Rasheed H, Mostafa WZ, Anbar TS, Abdallah M, Bassiouny D, Abdel-Halim D, Hegazy R, Eid AA, Nassar A, Abdel-Aziz RT, Fawzy MM, Gawdat HI, El Hawary M, Sany I, Shalaby S, Ragab N, Abdel-Gaber RM, Tawfik YM, El-Bassiouny M, El-Husseiny R, Attia MS, Farid C, Genedy RM, Mogawer RM. Efficacy of narrow band UVB with or without OMP in stabilization of vitiligo activity in skin photo-types (III-V): A double-blind, randomized, placebo-controlled, prospective, multicenter study. Photodermatol Photoimmunol Photomed. 2022 May;38(3):277-287. doi: 10.1111/phpp.12749. Epub 2021 Nov 18.
PubMed 34726808Middelkamp-Hup MA, Bos JD, Rius-Diaz F, Gonzalez S, Westerhof W. Treatment of vitiligo vulgaris with narrow-band UVB and oral Polypodium leucotomos extract: a randomized double-blind placebo-controlled study. J Eur Acad Dermatol Venereol. 2007 Aug;21(7):942-50. doi: 10.1111/j.1468-3083.2006.02132.x.
PubMed 17659004Tonnard P, Verpaele A, Peeters G, Hamdi M, Cornelissen M, Declercq H. Nanofat grafting: basic research and clinical applications. Plast Reconstr Surg. 2013 Oct;132(4):1017-1026. doi: 10.1097/PRS.0b013e31829fe1b0.
PubMed 23783059
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Effect of Autologous Nanofat Injection in the Treatment of Vitiligo
- ClinicalTrials.gov ID
- NCT07763262
- Acronym / sponsor ID
- MS 8-3-2024
- Conditions
- Vitiligo Vulgaris
- Keywords
- vitiligo; Autologous nanofat; Nanofat injection; Narrowband ultraviolet B
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 13 Aug 2026 (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 randomized, split-site, within-participant controlled clinical study evaluated the efficacy and safety of a single session of autologous nanofat injection as an adjunct to narrowband ultraviolet B (NB-UVB) phototherapy in 20 adult patients with stable vitiligo. In each participant, one vitiligo site received autologous nanofat injection followed by NB-UVB phototherapy three times weekly for 3 months, while a comparable site received NB-UVB phototherapy alone. Treatment response was assessed by standardized photography performed by a blinded dermatologist, with evaluation of the onset and percentage of repigmentation, patient satisfaction, and treatment-related adverse effects.
Detailed description
This randomized, split-site, within-participant controlled clinical study was conducted to evaluate the efficacy and safety of a single session of autologous nanofat injection as an adjunctive treatment to narrowband ultraviolet B (NB-UVB) phototherapy in patients with stable vitiligo.
Twenty adult patients with stable vitiligo were included, with both male and female participants eligible for enrollment. Each participant served as his or her own control. Two comparable vitiligo sites were selected in each participant. One site was treated with a single session of autologous nanofat injection followed by NB-UVB phototherapy, while the other comparable site received NB-UVB phototherapy alone.
NB-UVB phototherapy was administered three times weekly for 3 months to both treatment sites according to the study protocol. The nanofat-treated site received a single session of autologous nanofat injection before the course of NB-UVB phototherapy.
Treatment response was assessed by standardized clinical examination and serial standardized digital photographs. Photographic assessments were performed by an independent dermatologist who was blinded to the treatment allocation of the sites.
The primary efficacy assessment was based on the onset and degree of repigmentation of the treated vitiligo lesions. The percentage of repigmentation was assessed by comparison with the baseline appearance and standardized photographic documentation.
Patient satisfaction with treatment was assessed during follow-up using a predefined satisfaction scale. Treatment-related adverse effects and local or systemic reactions were recorded throughout the study period.
The study was designed to determine whether adding a single session of autologous nanofat injection to NB-UVB phototherapy provided greater or faster repigmentation than NB-UVB phototherapy alone in patients with stable vitiligo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nanofat Injection + NB-UVB | Experimental | Procedure: Autologous Nanofat InjectionA single session of autologous nanofat injection was performed in the randomly assigned vitiligo site. Nanofat was prepared from the participant's own adipose tissue according to the study protocol and injected into the selected vitiligo lesion. |
| NB-UVB Alone | Active comparator | Other: NB-UVB PhototherapyNarrowband ultraviolet B (NB-UVB) phototherapy was administered to both the nanofat-treated and control sites three times weekly for 3 months according to the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 18 years or older.
- Male or female patients.
- Patients with clinically diagnosed stable vitiligo.
- Presence of comparable vitiligo sites suitable for the split-site study design.
- Ability to undergo autologous nanofat harvesting and injection.
Key exclusion criteria (9 listed)
- Active or progressive vitiligo.
- Active infection or inflammation at the treatment sites.
- Significant uncontrolled systemic disease that could interfere with treatment or assessment.
- Contraindication to NB-UVB phototherapy.
- Contraindication to the nanofat harvesting or injection procedure.
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 |
|---|---|---|
| Autologous Nanofat InjectionA single session of autologous nanofat injection was performed in the randomly assigned vitiligo site. Nanofat was prepared from the participant's own adipose tissue according to the study protocol and injected into the selected vitiligo lesion. | Procedure or surgery | Nanofat Injection + NB-UVB |
| NB-UVB PhototherapyNarrowband ultraviolet B (NB-UVB) phototherapy was administered to both the nanofat-treated and control sites three times weekly for 3 months according to the study protocol. | Other | NB-UVB Alone |
Primary outcome
Percentage of Repigmentation
Time frame: Baseline to 3 months
Percentage of repigmentation of the treated vitiligo site compared with baseline, assessed using standardized clinical and photographic evaluation and compared between the nanofat-treated site and the NB-UVB-only control site.
3 secondary outcomes
Onset of Repigmentation
Time frame: During the 3-month treatment period
Patient Satisfaction
Time frame: At the final 3-month assessment
Treatment-Related Adverse Effects
Time frame: From treatment initiation through 3 months
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 13 Aug 2026.
- Results publication: PubMed 38480997Thind A, Vinay K, Mehta H, Bishnoi A, Kumaran MS, Parsad D. Whole-body and targeted narrowband ultraviolet B phototherapy effectively stabilize acral vitiligo with negligible repigmentation beyond wrists and ankles: Results from a split-body randomized controlled trial. Photodermatol Photoimmunol Photomed. 2024 Mar;40(2):e12960. doi: 10.1111/phpp.12960.
- Results publication: PubMed 20961233Asawanonda P, Klahan SO. Tetrahydrocurcuminoid cream plus targeted narrowband UVB phototherapy for vitiligo: a preliminary randomized controlled study. Photomed Laser Surg. 2010 Oct;28(5):679-84. doi: 10.1089/pho.2009.2637.
- Results publication: PubMed 34726808Esmat SM, El-Mofty M, Rasheed H, Mostafa WZ, Anbar TS, Abdallah M, Bassiouny D, Abdel-Halim D, Hegazy R, Eid AA, Nassar A, Abdel-Aziz RT, Fawzy MM, Gawdat HI, El Hawary M, Sany I, Shalaby S, Ragab N, Abdel-Gaber RM, Tawfik YM, El-Bassiouny M, El-Husseiny R, Attia MS, Farid C, Genedy RM, Mogawer RM. Efficacy of narrow band UVB with or without OMP in stabilization of vitiligo activity in skin photo-types (III-V): A double-blind, randomized, placebo-controlled, prospective, multicenter study. Photodermatol Photoimmunol Photomed. 2022 May;38(3):277-287. doi: 10.1111/phpp.12749. Epub 2021 Nov 18.
- Results publication: PubMed 17659004Middelkamp-Hup MA, Bos JD, Rius-Diaz F, Gonzalez S, Westerhof W. Treatment of vitiligo vulgaris with narrow-band UVB and oral Polypodium leucotomos extract: a randomized double-blind placebo-controlled study. J Eur Acad Dermatol Venereol. 2007 Aug;21(7):942-50. doi: 10.1111/j.1468-3083.2006.02132.x.
- Results publication: PubMed 23783059Tonnard P, Verpaele A, Peeters G, Hamdi M, Cornelissen M, Declercq H. Nanofat grafting: basic research and clinical applications. Plast Reconstr Surg. 2013 Oct;132(4):1017-1026. doi: 10.1097/PRS.0b013e31829fe1b0.
- Individual participant dataSharing planned: No
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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.
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 Autologous Nanofat Injection and NB-UVB Phototherapy in people with Vitiligo Vulgaris, run by Benha 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 8 inclusion and 9 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 13 Aug 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 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?
Percentage of Repigmentation (time frame: Baseline to 3 months). 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 NCT07763262, which also lists 5 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 13 Aug 2026.