Tinea Corporis,Tinea Cruris,Tinea FacieiPhase 4NCT07920354
Comparative Efficacy of Luliconazole and Bifonazole Combined With Itraconazole in Dermatophytosis
A Phase 4 study testing Itraconazole, Luliconazole Cream 1% and Bifonazole cream 1% in people with Tinea Corporis,Tinea Cruris,Tinea Faciei, run by University of Faisalabad at 2 sites in Pakistan.
Trial summary
The goal of this randomized controlled trial is to compare the efficacy of topical luliconazole with topical bifonazole in adults aged 18-60 years with dermatophytosis. All participants will receive oral itraconazole, while either topical luliconazole or topical bifonazole will be added according to their assigned… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tinea Corporis,Tinea Cruris,Tinea Faciei
- What is being tested?
- Itraconazole, Luliconazole Cream 1% and Bifonazole cream 1%
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Dec 2026to Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of either gender
- Age 18 to 60 years.
- Clinically diagnosed cases of tinea cruris, tinea corporis and tinea faciei.
- Diagnosis confirmed by positive 10% KOH mount microscopy.
- Patients providing written informed consent.
- Patients willing to adhere to the treatment regimen and follow-up visits.
Who cannot join
- Pregnant or lactating females.
- Known hypersensitivity to itraconazole, luliconazole, or bifonazole.
- Diagnosed systemic fungal infections.
- Patients who have received topical or systemic antifungal therapy within the past 4 weeks.
- Patients with known liver disease.
- Patients with co-existing skin conditions that may interfere with assessment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites
Madinah Teaching Hospital
Faisalabad, Punjab Province, 38000
Areeba Basharat, MBBS, +923074396418, areebabasharat567@gmail.com
Sabeen Riaz, MBBS, +923157472819, drsabeenriaz907@gmail.com
Madinah Teaching Hospital
Faisalabad, Punjab Province
Areeba Basharat, MBBS
About this study
Official title: Effectiveness of Topical Luliconazole With Oral Itraconazole Versus Topical Bifonazole With Oral Itraconazole in Patients With Dermatophytosis: A Randomized Controlled Trial
The goal of this randomized controlled trial is to compare the efficacy of topical luliconazole with topical bifonazole in adults aged 18-60 years with dermatophytosis. All participants will receive oral itraconazole, while either topical luliconazole or topical bifonazole will be added according to their assigned treatment group. The main questions it aims to answer are:
- Does topical luliconazole result in greater improvement in clinical severity, as measured by the DeASI score, compared with topical bifonazole?
- Does topical luliconazole result in better mycological clearance on 10% KOH microscopy and lower relapse compared with topical bifonazole? Researchers will compare topical luliconazole with topical bifonazole, with oral itraconazole given to both groups, to assess differences in clinical improvement, mycological cure, and relapse.
Read more
Participants will:
- Receive oral itraconazole 100 mg once daily together with either topical luliconazole 1% or topical bifonazole 1% once daily for 28 days.
- Attend follow-up visits at weeks 2, 4, and 6 for clinical assessment, DeASI scoring, and 10% KOH microscopy.
Read the detailed description
Dermatophytosis is a superficial fungal infection caused by dermatophytes and commonly affects keratinized tissues such as the skin. In this study, dermatophytosis refers specifically to tinea faciei, tinea corporis, and tinea cruris.
Itraconazole is an oral antifungal commonly used in the treatment of dermatophytosis. Bifonazole is a topical antifungal that has been used for the treatment of dermatophyte infections, while luliconazole is a newer topical antifungal agent with activity against dermatophytes.
There is limited direct clinical evidence comparing topical luliconazole with topical bifonazole when both are used along with oral itraconazole. In this study, oral itraconazole will be given to both groups, while the topical antifungal will differ. This will allow a direct comparison of the efficacy of topical luliconazole and topical bifonazole.
The study will be conducted as an open-label randomized controlled trial at the Department of Dermatology, Madinah Teaching Hospital, Faisalabad. The clinical and mycological outcomes of the two treatment groups will be compared.
- Conditions
- Tinea Corporis,Tinea Cruris,Tinea Faciei
- Being tested
- Itraconazole, Luliconazole Cream 1%, Bifonazole cream 1%
- Keywords
- Dermatophytosis,Luliconazole,Bifonazole,Itrazconazole,DeASI
- Medical subject headings
- Tinea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItraconazoleDrug
Itraconazole 100 mg orally twice daily for 28 days. It will be administered to participants in both treatment groups.
Luliconazole Cream 1%Drug
Luliconazole 1% cream applied topically once daily for 28 days to the affected areas.
Bifonazole cream 1%Drug
Bifonazole 1% cream applied topically once daily for 28 days to the affected areas.
| Study group | Role | What they receive |
|---|---|---|
| Luliconazole+Itraconazole | Experimental | Participants will receive oral itraconazole 100 mg twice daily for 28 days together with topical luliconazole 1% cream once daily for 28 days. Receives: Drug: Itraconazole; Drug: Luliconazole Cream 1% |
| Bifonazole+Itraconazole | Active comparator | Participants will receive oral itraconazole 100 mg twice daily for 28 days together with topical bifonazole 1% cream once daily for 28 days. Receives: Drug: Itraconazole; Drug: Bifonazole cream 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean reduction in DeASI score from baseline to Week 4
Mean reduction in Dermatophytosis Area and Severity Index (DeASI) score from baseline to Week 4, assessed by clinical examination and DeASI scoring.
Measured: Baseline to Week 4
Secondary outcomes (2)
Proportion of patients with negative 10% KOH microscopy at Week 4
Proportion of patients with negative 10% KOH microscopy at Week 4 after treatment.
Measured: Week 4
Proportion of patients with relapse at Week 6
Proportion of patients with relapse at Week 6 after treatment.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Tinea Corporis,Tinea Cruris,Tinea FacieiStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920354
- Sponsor's protocol ID
- UMDC/IRB/31/26
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers because the study data will be maintained by the research team for the purposes of this study, with participant confidentiality and privacy protected.
Publications
Amudha G, Bharathi MK, Mukund PR. Comparative Evaluation of Clinical Efficacy of Topical Luliconazole 1% versus Terbinafine 1% in Tinea Corporis and Tinea Cruris: A Clinical Scoring Analysis. Int J Life Sci Biotechnol Pharma Res. 2025;14(1).
Samal A, Singh BSTP, Kar BR, Mohapatra L. Comparison of Efficacy of Luliconazole 1% w/w Cream Versus Amorolfine 0.25% w/w Cream in the Treatment of Tinea cruris: A Single-center, Randomized, Double-blind, Non-inferiority Study. J Pure Appl Microbiol. 2024;18(4):2885-2894. doi:10.22207/JPAM.18.4.59.
Vyas A, Jain V. Luliconazole promising drug for Dermatophytes: A Review. Int J Technol. 2023;13(2):79-84. doi:10.52711/2231-3915.2023.00010.
Mucha P, Borkowski B, Erkiert-Polguj A, Budzisz E. Ciclopirox and Ciclopirox Olamine: Antifungal Agents in Dermatology with Expanding Therapeutic Potential. Appl Sci. 2024;14(24):11859. doi:10.3390/app142411859.
Abdolrasouli A, Borman AM, Johnson EM, Hay RJ, Arias M. Terbinafine-resistant Trichophyton indotineae causing extensive dermatophytosis in a returning traveller, London, UK. Clin Exp Dermatol. 2024 May 21;49(6):635-637. doi: 10.1093/ced/llae042. No abstract available.
PubMed 38320217Ortiz B, Ballesteros-Monrreal MG, Rosales-Tamashiro J, Bush M, Salmanton-Garcia J, Fontecha G. Global Insights and Trends in Research on Dermatophytes and Dermatophytosis: A Bibliometric Analysis. Mycoses. 2024 Oct;67(10):e13803. doi: 10.1111/myc.13803.
PubMed 39343727Lin B, Wang W, Ba W, Li H, Fan J. Preparation and partial pharmacodynamic studies of luliconazole ethosomes. Clin Exp Pharmacol Physiol. 2022 May;49(5):549-557. doi: 10.1111/1440-1681.13623. Epub 2022 Feb 28.
PubMed 35090058Ebrahimi Barogh R, Rahimnia SM, Nosratabadi M, Maleki A, Khosravi Ebrahimi F, Yahyazade Z, Haghani I, Ebrahimnejad P, Saeedi M, Armstrong-James D, Abastabar M, Badali H. Antifungal Efficacy of Luliconazole-Loaded Nanostructured Lipid-Carrier Gel in an Animal Model of Dermatophytosis. J Fungi (Basel). 2025 Apr 19;11(4):324. doi: 10.3390/jof11040324.
PubMed 40278144Sonego B, Corio A, Mazzoletti V, Zerbato V, Benini A, di Meo N, Zalaudek I, Stinco G, Errichetti E, Zelin E. Trichophyton indotineae, an Emerging Drug-Resistant Dermatophyte: A Review of the Treatment Options. J Clin Med. 2024 Jun 18;13(12):3558. doi: 10.3390/jcm13123558.
PubMed 38930086Tyagi H, Goel S, Puri A, Singla I, Rathore A. Comparative Efficacy of Three Oral Itraconazole Formulations in Superficial Dermatophytosis. Mycoses. 2025 Jun;68(6):e70080. doi: 10.1111/myc.70080.
PubMed 40536246Ali M, Ahmed N, Khan S, Kiran A. EFFICACY OF ORAL VORICONAZOLE VERSUS ORAL ITRACONAZOLE, IN THE TREATMENT OF DERMATOPHYTE INFECTIONS. J Ayub Med Coll Abbottabad. 2024 Apr-Jun;36(2):294-298. doi: 10.55519/JAMC-02-12891.
PubMed 39609968Priyadarshi D, Agarwal D, Talwar A. Safety and Efficacy of Oral Itraconazole versus Combination with Oral Isotretinoin in Superficial Dermatophytosis: A Randomised Clinical Trial. J Clin Diagn Res. 2023;17(5):WC01-WC05.
Chowdhary A, Singh A, Kaur A, Khurana A. The emergence and worldwide spread of the species Trichophyton indotineae causing difficult-to-treat dermatophytosis: A new challenge in the management of dermatophytosis. PLoS Pathog. 2022 Sep 29;18(9):e1010795. doi: 10.1371/journal.ppat.1010795. eCollection 2022 Sep. No abstract available.
PubMed 36173977Jartarkar SR, Patil A, Goldust Y, Cockerell CJ, Schwartz RA, Grabbe S, Goldust M. Pathogenesis, Immunology and Management of Dermatophytosis. J Fungi (Basel). 2021 Dec 31;8(1):39. doi: 10.3390/jof8010039.
PubMed 35049979Kaliyadan F, Das A, Ashique KT, Jayasree P, Panda M, Panda S, Chatterjee M, Dhafiri MA, Harrison P, Sasidharanpillai S, Samad KA, Jagadeesan S, Panicker VV, Kumar KA, Kumar P, Jakhar D, Samuel S, Rajalakshmi VP. Proposal for a Severity Score (DeASI, Dermatophytosis Area and Severity Index) for the Evaluation of Dermatophyte Infections - A Delphi Consensus Study. Indian J Dermatol. 2023 Nov-Dec;68(6):642-646. doi: 10.4103/ijd.ijd_266_23. Epub 2024 Jan 9.
PubMed 38371562
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Topical Luliconazole With Oral Itraconazole Versus Topical Bifonazole With Oral Itraconazole in Patients With Dermatophytosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07920354
- Acronym / sponsor ID
- UMDC/IRB/31/26
- Conditions
- Tinea Corporis,Tinea Cruris,Tinea Faciei
- Keywords
- Dermatophytosis,Luliconazole,Bifonazole,Itrazconazole,DeASI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- University of FaisalabadUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 5 Nov 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.
The goal of this randomized controlled trial is to compare the efficacy of topical luliconazole with topical bifonazole in adults aged 18-60 years with dermatophytosis. All participants will receive oral itraconazole, while either topical luliconazole or topical bifonazole will be added according to their assigned treatment group. The main questions it aims to answer are:
- Does topical luliconazole result in greater improvement in clinical severity, as measured by the DeASI score, compared with topical bifonazole?
- Does topical luliconazole result in better mycological clearance on 10% KOH microscopy and lower relapse compared with topical bifonazole? Researchers will compare topical luliconazole with topical bifonazole, with oral itraconazole given to both groups, to assess differences in clinical improvement, mycological cure, and relapse.
Participants will:
- Receive oral itraconazole 100 mg once daily together with either topical luliconazole 1% or topical bifonazole 1% once daily for 28 days.
- Attend follow-up visits at weeks 2, 4, and 6 for clinical assessment, DeASI scoring, and 10% KOH microscopy.
Detailed description
Dermatophytosis is a superficial fungal infection caused by dermatophytes and commonly affects keratinized tissues such as the skin. In this study, dermatophytosis refers specifically to tinea faciei, tinea corporis, and tinea cruris.
Itraconazole is an oral antifungal commonly used in the treatment of dermatophytosis. Bifonazole is a topical antifungal that has been used for the treatment of dermatophyte infections, while luliconazole is a newer topical antifungal agent with activity against dermatophytes.
There is limited direct clinical evidence comparing topical luliconazole with topical bifonazole when both are used along with oral itraconazole. In this study, oral itraconazole will be given to both groups, while the topical antifungal will differ. This will allow a direct comparison of the efficacy of topical luliconazole and topical bifonazole.
The study will be conducted as an open-label randomized controlled trial at the Department of Dermatology, Madinah Teaching Hospital, Faisalabad. The clinical and mycological outcomes of the two treatment groups will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Luliconazole+Itraconazole | Experimental | Drug: Itraconazole, Drug: Luliconazole Cream 1%Participants will receive oral itraconazole 100 mg twice daily for 28 days together with topical luliconazole 1% cream once daily for 28 days. |
| Bifonazole+Itraconazole | Active comparator | Drug: Itraconazole, Drug: Bifonazole cream 1%Participants will receive oral itraconazole 100 mg twice daily for 28 days together with topical bifonazole 1% cream once daily for 28 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients of either gender
- Age 18 to 60 years.
- Clinically diagnosed cases of tinea cruris, tinea corporis and tinea faciei.
- Diagnosis confirmed by positive 10% KOH mount microscopy.
- Patients providing written informed consent.
Key exclusion criteria (6 listed)
- Pregnant or lactating females.
- Known hypersensitivity to itraconazole, luliconazole, or bifonazole.
- Diagnosed systemic fungal infections.
- Patients who have received topical or systemic antifungal therapy within the past 4 weeks.
- Patients with known liver disease.
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 |
|---|---|---|
| ItraconazoleItraconazole 100 mg orally twice daily for 28 days. It will be administered to participants in both treatment groups. | Drug | Bifonazole+Itraconazole, Luliconazole+Itraconazole |
| Luliconazole Cream 1%Luliconazole 1% cream applied topically once daily for 28 days to the affected areas. | Drug | Luliconazole+Itraconazole |
| Bifonazole cream 1%Bifonazole 1% cream applied topically once daily for 28 days to the affected areas. | Drug | Bifonazole+Itraconazole |
Primary outcome
Mean reduction in DeASI score from baseline to Week 4
Time frame: Baseline to Week 4
Mean reduction in Dermatophytosis Area and Severity Index (DeASI) score from baseline to Week 4, assessed by clinical examination and DeASI scoring.
2 secondary outcomes
Proportion of patients with negative 10% KOH microscopy at Week 4
Time frame: Week 4
Proportion of patients with relapse at Week 6
Time frame: Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- BackgroundAmudha G, Bharathi MK, Mukund PR. Comparative Evaluation of Clinical Efficacy of Topical Luliconazole 1% versus Terbinafine 1% in Tinea Corporis and Tinea Cruris: A Clinical Scoring Analysis. Int J Life Sci Biotechnol Pharma Res. 2025;14(1).
- BackgroundSamal A, Singh BSTP, Kar BR, Mohapatra L. Comparison of Efficacy of Luliconazole 1% w/w Cream Versus Amorolfine 0.25% w/w Cream in the Treatment of Tinea cruris: A Single-center, Randomized, Double-blind, Non-inferiority Study. J Pure Appl Microbiol. 2024;18(4):2885-2894. doi:10.22207/JPAM.18.4.59.
- BackgroundVyas A, Jain V. Luliconazole promising drug for Dermatophytes: A Review. Int J Technol. 2023;13(2):79-84. doi:10.52711/2231-3915.2023.00010.
- BackgroundMucha P, Borkowski B, Erkiert-Polguj A, Budzisz E. Ciclopirox and Ciclopirox Olamine: Antifungal Agents in Dermatology with Expanding Therapeutic Potential. Appl Sci. 2024;14(24):11859. doi:10.3390/app142411859.
- Background: PubMed 38320217Abdolrasouli A, Borman AM, Johnson EM, Hay RJ, Arias M. Terbinafine-resistant Trichophyton indotineae causing extensive dermatophytosis in a returning traveller, London, UK. Clin Exp Dermatol. 2024 May 21;49(6):635-637. doi: 10.1093/ced/llae042. No abstract available.
- Background: PubMed 39343727Ortiz B, Ballesteros-Monrreal MG, Rosales-Tamashiro J, Bush M, Salmanton-Garcia J, Fontecha G. Global Insights and Trends in Research on Dermatophytes and Dermatophytosis: A Bibliometric Analysis. Mycoses. 2024 Oct;67(10):e13803. doi: 10.1111/myc.13803.
- Background: PubMed 35090058Lin B, Wang W, Ba W, Li H, Fan J. Preparation and partial pharmacodynamic studies of luliconazole ethosomes. Clin Exp Pharmacol Physiol. 2022 May;49(5):549-557. doi: 10.1111/1440-1681.13623. Epub 2022 Feb 28.
- Background: PubMed 40278144Ebrahimi Barogh R, Rahimnia SM, Nosratabadi M, Maleki A, Khosravi Ebrahimi F, Yahyazade Z, Haghani I, Ebrahimnejad P, Saeedi M, Armstrong-James D, Abastabar M, Badali H. Antifungal Efficacy of Luliconazole-Loaded Nanostructured Lipid-Carrier Gel in an Animal Model of Dermatophytosis. J Fungi (Basel). 2025 Apr 19;11(4):324. doi: 10.3390/jof11040324.
- Background: PubMed 38930086Sonego B, Corio A, Mazzoletti V, Zerbato V, Benini A, di Meo N, Zalaudek I, Stinco G, Errichetti E, Zelin E. Trichophyton indotineae, an Emerging Drug-Resistant Dermatophyte: A Review of the Treatment Options. J Clin Med. 2024 Jun 18;13(12):3558. doi: 10.3390/jcm13123558.
- Background: PubMed 40536246Tyagi H, Goel S, Puri A, Singla I, Rathore A. Comparative Efficacy of Three Oral Itraconazole Formulations in Superficial Dermatophytosis. Mycoses. 2025 Jun;68(6):e70080. doi: 10.1111/myc.70080.
- Background: PubMed 39609968Ali M, Ahmed N, Khan S, Kiran A. EFFICACY OF ORAL VORICONAZOLE VERSUS ORAL ITRACONAZOLE, IN THE TREATMENT OF DERMATOPHYTE INFECTIONS. J Ayub Med Coll Abbottabad. 2024 Apr-Jun;36(2):294-298. doi: 10.55519/JAMC-02-12891.
- BackgroundPriyadarshi D, Agarwal D, Talwar A. Safety and Efficacy of Oral Itraconazole versus Combination with Oral Isotretinoin in Superficial Dermatophytosis: A Randomised Clinical Trial. J Clin Diagn Res. 2023;17(5):WC01-WC05.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers because the study data will be maintained by the research team for the purposes of this study, with participant confidentiality and privacy protected.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Itraconazole, Luliconazole Cream 1% and Bifonazole cream 1% in people with Tinea Corporis,Tinea Cruris,Tinea Faciei, run by University of Faisalabad at 2 sites in Pakistan.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Areeba Basharat, MBBS (+923074396418, areebabasharat567@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean reduction in DeASI score from baseline to Week 4 (time frame: Baseline to Week 4). 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 NCT07920354, which also lists 15 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 5 Nov 2026.