Alopecia Totalis/UniversalisNCT07101471
Rhofanib® (Tofacitinib) Safety and Effectiveness Evaluation
An observational study of Alopecia Totalis/Universalis and Alopecia Areata(AA), run by NanoAlvand at 1 site in Iran.
Trial summary
The goal of this observational study is to evaluate safety of Rhofanib® (Tofacitinib) in male or female participants with the age of 18 years or older having clinical diagnosis of Alopecia. The main questions are aim to answer: 1. Is Rhofanib® (Tofacitinib) safe in Alopecia? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia Totalis/Universalis, Alopecia Areata(AA)
- What is being tested?
- Tofacitinib
- How many people
- 296 participants
- Where
- 1 siteIran
- Study dates
- 4 Aug 2020to 11 Jun 2025
- Phase
- Observational
- 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
Study population: Primary care clinic
Who may be able to join
- Male or female with the age of 18 years or older
- Clinical diagnosis of alopecia areata with at least 40% scalp hair loss, alopecia totalis, or alopecia universalis who are prescribed Rhofanib®
- Stable or worsening disease for at least 6 months
- Patients who have given written authorization to use their personal health data for the purpose of this study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective and Observational Study for Safety and Effectiveness Evaluation of Rhofanib® (Tofacitinib) in Patients With Alopecia.
The goal of this observational study is to evaluate safety of Rhofanib® (Tofacitinib) in male or female participants with the age of 18 years or older having clinical diagnosis of Alopecia. The main questions are aim to answer:
- Is Rhofanib® (Tofacitinib) safe in Alopecia?
- Is Rhofanib® (Tofacitinib) work to treat Alopecia?
In this study, there is no comparison group. Participants received Rhofanib® (Tofacitinib) with or without adjuvant prednisolone.
Read the detailed description
This study is a phase IV, post-marketing, observational, cohort study for the safety and effectiveness evaluation of Rhofanib® (Tofacitinib) use in Iranian participants with alopecia with at least 40% scalp hair loss, alopecia totalis, or alopecia universalis.
Researchers and investigators gathered data in booklets. Exposure to Rhofanib® (Tofacitinib) in this study was defined as administration of Rhofanib® (Tofacitinib) with a suggested dose of 5 mg twice daily with or without adjuvant prednisolone.
The primary objective of this study was safety assessment, including the incidence of the most common adverse events (AEs), serious adverse events, and death during the study period.
The secondary objective is the effectiveness of Rhofanib® (Tofacitinib) by assessment of the Severity of Alopecia Tool (SALT) score, disease relapse (Patchy or complete scalp hair loss), eyebrow and eyelash status affected by alopecia, and also participants' quality of life-based on Dermatology life quality index (DLQI) during the study period.
This study was a single arm and the sample size of this study was 353 participants.
- Conditions
- Alopecia Totalis/Universalis, Alopecia Areata(AA)
- Being tested
- Tofacitinib
- Keywords
- tofacitinib, Alopecia Areata, Severity of Alopecia Tool score, Alopecia Universalis, Alopecia Totalis
- Medical subject headings
- Alopecia Areata, Alopecia universalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TofacitinibDrug
Tofacitinib with a suggested dose of 5 mg twice daily with or without adjuvant prednisolone.
| Study group | Role | What they receive |
|---|---|---|
| Participants received Rhofanib® (Tofacitinib) | Not described Receives: Drug: Tofacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment
Safety assessment, including the incidence of AEs. All AEs are classified based on the Medical Dictionary for Regulatory Activities (MedDRA Desktop Browser 4.0 Beta) terms as System Organ Class (SOC) and Preferred Term (PT). All the reported events are graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Moreover, seriousness of AEs is assessed according to International Council for Harmonisation (ICH-E2B) guidelines. The causality relation is assessed based on the World Health Organization (WHO) criteria.
Measured: Study period ( Up to 6 months)
Secondary outcomes (4)
The percentage of change from baseline in the Severity of Alopecia Tool (SALT) Score
Severity of Alopecia Tool (SALT) Score is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Measured: Study period (up to 6 months)
The frequency of relapse disease (Patchy or complete scalp hair loss).
Measured: Study period (up to 6 months)
The frequency and proportion of participants achieved greater or equivalent to one grade improvement in eyelash/ eyebrow scores
It is a 4-point scale that is used to assess the severity of eyebrow and eyelash hair loss in Alopecia, with the scale ranging from 0 to 3. The score of 0 equals to worth case, and the score of 3 indicates normal.
Measured: Study period (up to 6 months)
Change in Dermatology Life Quality Index Total Score (DLQI)
Dermatology Life Quality Index Total Score (DLQI) is a questionnaire that ranges from 0 to 30. Higher scores indicate a greater negative impact on quality of life.
Measured: Study period (up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start4 Aug 2020
- Primary completion11 Jun 2025
- Study completion11 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alopecia Totalis/UniversalisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- NanoAlvand
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101471
- Sponsor's protocol ID
- RHO.NA.SD.IV.99
- Status last verified
- Aug 2025
- First submitted
- 28 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data produced in the present study are available upon reasonable request from the investigators.
Publications
Wohltmann WE. JAAD Game Changers: Tofacitinib for the treatment of severe alopecia areata and variants: A study of 90 patients. J Am Acad Dermatol. 2024 Nov;91(5):825. doi: 10.1016/j.jaad.2024.05.064. Epub 2024 May 31. No abstract available.
PubMed 38823686Liu LY, King BA. Tofacitinib for the Treatment of Severe Alopecia Areata in Adults and Adolescents. J Investig Dermatol Symp Proc. 2018 Jan;19(1):S18-S20. doi: 10.1016/j.jisp.2017.10.003.
PubMed 29273099Liu LY, Craiglow BG, Dai F, King BA. Tofacitinib for the treatment of severe alopecia areata and variants: A study of 90 patients. J Am Acad Dermatol. 2017 Jan;76(1):22-28. doi: 10.1016/j.jaad.2016.09.007. Epub 2016 Nov 2.
PubMed 27816293
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective and Observational Study for Safety and Effectiveness Evaluation of Rhofanib® (Tofacitinib) in Patients With Alopecia.
- ClinicalTrials.gov ID
- NCT07101471
- Acronym / sponsor ID
- RHO.NA.SD.IV.99
- Conditions
- Alopecia Totalis/Universalis, Alopecia Areata(AA)
- Keywords
- tofacitinib, Alopecia Areata, Severity of Alopecia Tool score, Alopecia Universalis, Alopecia Totalis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- NanoAlvandIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 11 Jun 2025 (actual)
- Study completion
- 11 Jun 2025 (actual)
- First posted
- 3 Aug 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.
The goal of this observational study is to evaluate safety of Rhofanib® (Tofacitinib) in male or female participants with the age of 18 years or older having clinical diagnosis of Alopecia. The main questions are aim to answer:
- Is Rhofanib® (Tofacitinib) safe in Alopecia?
- Is Rhofanib® (Tofacitinib) work to treat Alopecia?
In this study, there is no comparison group. Participants received Rhofanib® (Tofacitinib) with or without adjuvant prednisolone.
Detailed description
This study is a phase IV, post-marketing, observational, cohort study for the safety and effectiveness evaluation of Rhofanib® (Tofacitinib) use in Iranian participants with alopecia with at least 40% scalp hair loss, alopecia totalis, or alopecia universalis.
Researchers and investigators gathered data in booklets. Exposure to Rhofanib® (Tofacitinib) in this study was defined as administration of Rhofanib® (Tofacitinib) with a suggested dose of 5 mg twice daily with or without adjuvant prednisolone.
The primary objective of this study was safety assessment, including the incidence of the most common adverse events (AEs), serious adverse events, and death during the study period.
The secondary objective is the effectiveness of Rhofanib® (Tofacitinib) by assessment of the Severity of Alopecia Tool (SALT) score, disease relapse (Patchy or complete scalp hair loss), eyebrow and eyelash status affected by alopecia, and also participants' quality of life-based on Dermatology life quality index (DLQI) during the study period.
This study was a single arm and the sample size of this study was 353 participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants received Rhofanib® (Tofacitinib) | – | Drug: Tofacitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (4 listed)
- Male or female with the age of 18 years or older
- Clinical diagnosis of alopecia areata with at least 40% scalp hair loss, alopecia totalis, or alopecia universalis who are prescribed Rhofanib®
- Stable or worsening disease for at least 6 months
- Patients who have given written authorization to use their personal health data for the purpose of this study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| TofacitinibTofacitinib with a suggested dose of 5 mg twice daily with or without adjuvant prednisolone. | Drug | Participants received Rhofanib® (Tofacitinib) |
Primary outcome
Safety assessment
Time frame: Study period ( Up to 6 months)
Safety assessment, including the incidence of AEs. All AEs are classified based on the Medical Dictionary for Regulatory Activities (MedDRA Desktop Browser 4.0 Beta) terms as System Organ Class (SOC) and Preferred Term (PT). All the reported events are graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Moreover, seriousness of AEs is assessed according to International Council for Harmonisation (ICH-E2B) guidelines. The causality relation is assessed based on the World Health Organization (WHO) criteria.
4 secondary outcomes
The percentage of change from baseline in the Severity of Alopecia Tool (SALT) Score
Time frame: Study period (up to 6 months)
The frequency of relapse disease (Patchy or complete scalp hair loss).
Time frame: Study period (up to 6 months)
The frequency and proportion of participants achieved greater or equivalent to one grade improvement in eyelash/ eyebrow scores
Time frame: Study period (up to 6 months)
Change in Dermatology Life Quality Index Total Score (DLQI)
Time frame: Study period (up to 6 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 7 Aug 2025.
- Results publication: PubMed 38823686Wohltmann WE. JAAD Game Changers: Tofacitinib for the treatment of severe alopecia areata and variants: A study of 90 patients. J Am Acad Dermatol. 2024 Nov;91(5):825. doi: 10.1016/j.jaad.2024.05.064. Epub 2024 May 31. No abstract available.
- Results publication: PubMed 29273099Liu LY, King BA. Tofacitinib for the Treatment of Severe Alopecia Areata in Adults and Adolescents. J Investig Dermatol Symp Proc. 2018 Jan;19(1):S18-S20. doi: 10.1016/j.jisp.2017.10.003.
- Results publication: PubMed 27816293Liu LY, Craiglow BG, Dai F, King BA. Tofacitinib for the treatment of severe alopecia areata and variants: A study of 90 patients. J Am Acad Dermatol. 2017 Jan;76(1):22-28. doi: 10.1016/j.jaad.2016.09.007. Epub 2016 Nov 2.
- Individual participant dataSharing planned: No. Data produced in the present study are available upon reasonable request from the investigators.
Related trials for Alopecia Totalis/Universalis
RecruitingPhase 3
A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata
Alopecia Areata
Active, not recruitingPhase 2
Clinical Application of Stem Cell Educator Therapy in Alopecia Areata
Alopecia Areata, Alopecia Totalis
RecruitingPhase 2
Evaluation of Microbiota Transplant Therapy in Patients With Alopecia Areata
Alopecia Areata, Alopecia Totalis
Not yet recruitingPhase 4
Tofacitinib vs Methotrexate for Severe Alopecia Areata (TOFA-MTX-AA)
Alopecia Areata, Alopecia Totalis (AT)
RecruitingPhase 4
Cyclosporine Or Methotrexate for Pediatric Alopecia Areata: Routine Clinical Care Effectiveness Study
Alopecia Areata(AA), Alopecia Areata (AA)
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?
An observational study of Alopecia Totalis/Universalis and Alopecia Areata(AA), run by NanoAlvand at 1 site in Iran.
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 0 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 7 Aug 2025. 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 Iran. 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?
Safety assessment (time frame: Study period ( Up to 6 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 NCT07101471, which also lists 3 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 7 Aug 2025.