ClinicalTrials.gg
Not yet recruitingNCT06863454Updated Mar 7, 2025

Trichoscopy as a Monitoring Tool for Activity and Remission in Pemphigus Vulgaris: A Clinical Study Supported by Immunological Evaluation.

An observational study in Pemphigus Vulgaris (PV), sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2025-03-07.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 6 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
62
Sex
All
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Study summary

Pemphigus vulgaris (PV) is a potential life-threatening autoimmune bullous disorder presenting with multiple erosions and flaccid blisters that can involve both mucous membrane and skin. The microscopic findings include intraepithelial blisters caused by acantholysis of keratinocytes as the consequence of autoantibody formation. The antibodies are mainly IgG autoantibodies mostly directed against desmoglein 1 and 3 (Dsg 1, 3), which are adhesion molecules expressed on the surface of keratinocytes.

Read the detailed description

Scalp is a unique location for pemphigus because of the abundance of desmogleins localized in hair follicles. The frequency of scalp involvement in the course of pemphigus is estimated at 16-60% . According to literature data, the scalp is the first location in 9-15% of patients with pemphigus.

Several cases of alopecia in the course of pemphigus have been described. The significance of the distribution of desmogleins in hair follicles for scalp involvement and a potential use of direct immunofluorescence of plucked hairs are discussed in the literature. The significance of scalp involvement for the course of pemphigus remains controversial.

Trichoscopy is a non-invasive method for diagnosing hair and scalp disorders. Trichoscopy is widely used to differentiate causes of scalp lesions and scarring and non-scarring alopecia. To date there are few studies on the value of trichoscopy in pemphigus.

The pathogenesis and pathophysiology of PV depend on various factors like cellular immunity, genetic factors, ethnicity, diet and environment. According to previous studies, Dsg autoantibodies with IgG1 and IgG4 subtypes are mostly detected in the active form of the pemphigus diseases. Accordingly, the significant role of autoreactive B cells in the pathogenesis of PV could be explained by producing these types of autoantibodies.

Recently attention has been directed toward the role of T cells in the pathogenesis of PV. Similar to other autoimmune diseases, the underlying etiology of PV depends on the interaction between T cells and B cells resulting in antibody secretion.

Autoreactive CD4+ T cells are essential for the pathogenesis of several ab-mediated autoimmune diseases by providing help to autoreactive B cells resulting in the production of antigen specific auto-ab. Alterations in several T cell subsets like CD4+CD25+ Treg and Th17 cells, have been described and are suggested to play a role in the pathogenesis of pemphigus.

A few studies have investigated the significant role of T cell subgroups, namely regulatory T cells (Treg), T helper17 (Th17), and T follicular helper cells (Tfh) in PV and some studies were carried out on both human and mouse models to meticulously reveal the function of T cell phenotypes including CD8+T cells, γδ T cells, and resident memory T cells in the pathogenesis of PV, which may explain the wide range of clinical presentations and severity of PV in patients.

02

Conditions studied

  • Pemphigus Vulgaris (PV)

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03

In context

Pemphigus

76 studies on the registry are indexed under Pemphigus; 18 are open to participants now.

This study's planned enrollment of 62 is close to the median of 60 across 21 observational studies indexed under Pemphigus.

Browse Pemphigus studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients will be recruited from those attending the Bullous outpatient clinic of department of Dermatology, Assiut University Hospitals with the diagnosis of pemphigus vulgaris. Patients will be included in the study after obtaining a written informed consent. And after the approval of the faculty of medicine ethics committee. An age and sex matched healthy volunteers will be recruited as a control group.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with clinical and histopathological diagnosis of pemphigus vulgaris will be included.
  • Pemphigus patients are categorized as active or remittent.

Exclusion criteria

Exclusion Criteria:

  • Other forms of pemphigus.
  • Patients who are previously treated with rituximab.
  • Patients with any concomitant dermatological diseases.
  • Patients with other diseases.
  • Pregnancy and lactation.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
62 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group 1

    cases of PV with disease activity

    Diagnostic Test: Trichoscopy

  • Group 2

    cases of PV with disease remission

    Diagnostic Test: Trichoscopy

  • Group 3

    control group

Interventions

  • Diagnostic testTrichoscopy

    Trichoscopy will be done on patients with PV disease activity and remission

06

What researchers measure

Primary outcomes

  1. Trichoscopy as a monitooring tool

    for activity and remission in PV

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Xu RC, Zhu HQ, Li WP, Zhao XQ, Yuan HJ, Zheng J, Pan M. The imbalance of Th17 and regulatory T cells in pemphigus patients. Eur J Dermatol. 2013 Nov-Dec;23(6):795-802. doi: 10.1684/ejd.2013.2177. PubMed 24192290 ↗
  • Wu H, Stanley JR, Cotsarelis G. Desmoglein isotype expression in the hair follicle and its cysts correlates with type of keratinization and degree of differentiation. J Invest Dermatol. 2003 Jun;120(6):1052-7. doi: 10.1046/j.1523-1747.2003.12234.x. Erratum In: J Invest Dermatol. 2003 Aug;121(2):434. PubMed 12787134 ↗
  • Veraitch O, Ohyama M, Yamagami J, Amagai M. Alopecia as a rare but distinct manifestation of pemphigus vulgaris. J Eur Acad Dermatol Venereol. 2013 Jan;27(1):86-91. doi: 10.1111/j.1468-3083.2011.04363.x. Epub 2011 Nov 28. PubMed 22122058 ↗
  • Tavakolpour S, Mahmoudi H, Mirzazadeh A, Balighi K, Darabi-Monadi S, Hatami S, GhasemiAdl M, Daneshpazhooh M. Pathogenic and protective roles of cytokines in pemphigus: A systematic review. Cytokine. 2020 May;129:155026. doi: 10.1016/j.cyto.2020.155026. Epub 2020 Feb 10. PubMed 32058276 ↗
  • Takahashi H, Amagai M, Nishikawa T, Fujii Y, Kawakami Y, Kuwana M. Novel system evaluating in vivo pathogenicity of desmoglein 3-reactive T cell clones using murine pemphigus vulgaris. J Immunol. 2008 Jul 15;181(2):1526-35. doi: 10.4049/jimmunol.181.2.1526. PubMed 18606708 ↗
  • Sar-Pomian M, Rudnicka L, Olszewska M. The Significance of Scalp Involvement in Pemphigus: A Literature Review. Biomed Res Int. 2018 Mar 25;2018:6154397. doi: 10.1155/2018/6154397. eCollection 2018. PubMed 29770335 ↗
  • Sar-Pomian M, Rudnicka L, Olszewska M. Trichoscopy - a useful tool in the preliminary differential diagnosis of autoimmune bullous diseases. Int J Dermatol. 2017 Oct;56(10):996-1002. doi: 10.1111/ijd.13725. Epub 2017 Aug 30. PubMed 28856676 ↗
  • Sar-Pomian M, Kurzeja M, Rudnicka L, Olszewska M. The value of trichoscopy in the differential diagnosis of scalp lesions in pemphigus vulgaris and pemphigus foliaceus. An Bras Dermatol. 2014 Nov-Dec;89(6):1007-12. doi: 10.1590/abd1806-4841.20143830. PubMed 25387515 ↗
  • Salmanpour R, Shahkar H, Namazi MR, Rahman-Shenas MR. Epidemiology of pemphigus in south-western Iran: a 10-year retrospective study (1991-2000). Int J Dermatol. 2006 Feb;45(2):103-5. doi: 10.1111/j.1365-4632.2004.02374.x. PubMed 16445496 ↗
  • Saleh MA, Ishii K, Yamagami J, Shirakata Y, Hashimoto K, Amagai M. Pathogenic anti-desmoglein 3 mAbs cloned from a paraneoplastic pemphigus patient by phage display. J Invest Dermatol. 2012 Apr;132(4):1141-8. doi: 10.1038/jid.2011.449. Epub 2012 Jan 26. PubMed 22277944 ↗
  • Rudnicka L, Olszewska M, Rakowska A, Slowinska M. Trichoscopy update 2011. J Dermatol Case Rep. 2011 Dec 12;5(4):82-8. doi: 10.3315/jdcr.2011.1083. PubMed 22408709 ↗
  • Rudnicka L, Olszewska M, Rakowska A, Kowalska-Oledzka E, Slowinska M. Trichoscopy: a new method for diagnosing hair loss. J Drugs Dermatol. 2008 Jul;7(7):651-4. PubMed 18664157 ↗
  • Rosenbach M, Murrell DF, Bystryn JC, Dulay S, Dick S, Fakharzadeh S, Hall R, Korman NJ, Lin J, Okawa J, Pandya AG, Payne AS, Rose M, Rubenstein D, Woodley D, Vittorio C, Werth BB, Williams EA, Taylor L, Troxel AB, Werth VP. Reliability and convergent validity of two outcome instruments for pemphigus. J Invest Dermatol. 2009 Oct;129(10):2404-10. doi: 10.1038/jid.2009.72. Epub 2009 Apr 9. PubMed 19357707 ↗
  • Rahbar Z, Daneshpazhooh M, Mirshams-Shahshahani M, Esmaili N, Heidari K, Aghazadeh N, Hejazi P, Ghajarzadeh M, Chams-Davatchi C. Pemphigus disease activity measurements: pemphigus disease area index, autoimmune bullous skin disorder intensity score, and pemphigus vulgaris activity score. JAMA Dermatol. 2014 Mar;150(3):266-72. doi: 10.1001/jamadermatol.2013.8175. PubMed 24429657 ↗
  • Pisanti S, Sharav Y, Kaufman E, Posner LN. Pemphigus vulgaris: incidence in Jews of different ethnic groups, according to age, sex, and initial lesion. Oral Surg Oral Med Oral Pathol. 1974 Sep;38(3):382-7. doi: 10.1016/0030-4220(74)90365-x. No abstract available. PubMed 4528670 ↗
  • Pirmez R. Acantholytic hair casts: a dermoscopic sign of pemphigus vulgaris of the scalp. Int J Trichology. 2012 Jul;4(3):172-3. doi: 10.4103/0974-7753.100087. PubMed 23180929 ↗
  • Murrell DF, Dick S, Ahmed AR, Amagai M, Barnadas MA, Borradori L, Bystryn JC, Cianchini G, Diaz L, Fivenson D, Hall R, Harman KE, Hashimoto T, Hertl M, Hunzelmann N, Iranzo P, Joly P, Jonkman MF, Kitajima Y, Korman NJ, Martin LK, Mimouni D, Pandya AG, Payne AS, Rubenstein D, Shimizu H, Sinha AA, Sirois D, Zillikens D, Werth VP. Consensus statement on definitions of disease, end points, and therapeutic response for pemphigus. J Am Acad Dermatol. 2008 Jun;58(6):1043-6. doi: 10.1016/j.jaad.2008.01.012. Epub 2008 Mar 14. PubMed 18339444 ↗
  • Kasperkiewicz M, Ellebrecht CT, Takahashi H, Yamagami J, Zillikens D, Payne AS, Amagai M. Pemphigus. Nat Rev Dis Primers. 2017 May 11;3:17026. doi: 10.1038/nrdp.2017.26. PubMed 28492232 ↗
  • Hennerici T, Pollmann R, Schmidt T, Seipelt M, Tackenberg B, Mobs C, Ghoreschi K, Hertl M, Eming R. Increased Frequency of T Follicular Helper Cells and Elevated Interleukin-27 Plasma Levels in Patients with Pemphigus. PLoS One. 2016 Feb 12;11(2):e0148919. doi: 10.1371/journal.pone.0148919. eCollection 2016. PubMed 26872212 ↗
  • Hebert V, Boulard C, Houivet E, Duvert Lehembre S, Borradori L, Della Torre R, Feliciani C, Fania L, Zambruno G, Camaioni DB, Didona B, Marinovic B, Schmidt E, Schumacher N, Hunefeld C, Schanz S, Kern JS, Hofmann S, Bouyeure AC, Picard-Dahan C, Prost-Squarcioni C, Caux F, Alexandre M, Ingen-Housz-Oro S, Bagot M, Tancrede-Bohin E, Bouaziz JD, Franck N, Vabres P, Labeille B, Richard MA, Delaporte E, Dupuy A, D'Incan M, Quereux G, Skowro F, Paul C, Livideanu CB, Beylot-Barry M, Doutre MS, Avenel-Audran M, Bedane C, Bernard P, Machet L, Maillard H, Jullien D, Debarbieux S, Sassolas B, Misery L, Abasq C, Dereure O, Lagoutte P, Ferranti V, Werth VP, Murrell DF, Hertl M, Benichou J, Joly P; French Study Group on Autoimmune Bullous Skin Diseases; Autoimmune Bullous Skin Disease Task Force of the European Academy of Dermatology and Venereology. Large International Validation of ABSIS and PDAI Pemphigus Severity Scores. J Invest Dermatol. 2019 Jan;139(1):31-37. doi: 10.1016/j.jid.2018.04.042. Epub 2018 Oct 6. PubMed 30301637 ↗
  • Hammers CM, Stanley JR. Mechanisms of Disease: Pemphigus and Bullous Pemphigoid. Annu Rev Pathol. 2016 May 23;11:175-97. doi: 10.1146/annurev-pathol-012615-044313. Epub 2016 Feb 22. PubMed 26907530 ↗
  • Fang H, Li Q, Wang G. The role of T cells in pemphigus vulgaris and bullous pemphigoid. Autoimmun Rev. 2020 Nov;19(11):102661. doi: 10.1016/j.autrev.2020.102661. Epub 2020 Sep 14. PubMed 32942041 ↗
  • Esmaili N, Chams-Davatchi C, Valikhani M, Daneshpazhooh M, Balighi K, Hallaji Z, Barzegari M, Akhyani M, Ghodsi ZS, Mrotazavi H, Naraghi ZS, Toosi S. Pemphigus vulgaris in Iran: a clinical study of 140 cases. Int J Dermatol. 2007 Nov;46(11):1166-70. doi: 10.1111/j.1365-4632.2007.03334.x. PubMed 17988336 ↗
  • David M, Katzenelson V, Hazaz B, Ben-Chetrit A, Sandbank M. Determination of IgG subclasses in patients with pemphigus with active disease and in remission. Arch Dermatol. 1989 Jun;125(6):787-90. PubMed 2658844 ↗
  • Daneshpazhooh M, Naraghi ZS, Ramezani A, Ghanadan A, Esmaili N, Chams-Davatchi C. Direct immunofluorescence of plucked hair for evaluation of immunologic remission in pemphigus vulgaris. J Am Acad Dermatol. 2011 Dec;65(6):e173-7. doi: 10.1016/j.jaad.2010.09.721. Epub 2011 Jun 22. PubMed 21696851 ↗
  • Berrih-Aknin S, Le Panse R. Myasthenia gravis: a comprehensive review of immune dysregulation and etiological mechanisms. J Autoimmun. 2014 Aug;52:90-100. doi: 10.1016/j.jaut.2013.12.011. Epub 2014 Jan 3. PubMed 24389034 ↗
  • Asothai R, Anand V, Das D, Antil PS, Khandpur S, Sharma VK, Sharma A. Distinctive Treg associated CCR4-CCL22 expression profile with altered frequency of Th17/Treg cell in the immunopathogenesis of Pemphigus Vulgaris. Immunobiology. 2015 Oct;220(10):1129-35. doi: 10.1016/j.imbio.2015.06.008. Epub 2015 Jun 17. PubMed 26093920 ↗
  • Arya SR, Valand AG, Krishna K. A clinico-pathological study of 70 cases of pemphigus. Indian J Dermatol Venereol Leprol. 1999 Jul-Aug;65(4):168-71. PubMed 20921646 ↗
  • Araghi F, Dadkhahfar S, Robati RM, Tabary M, Shahidi-Dadras M. The emerging role of T cells in pemphigus vulgaris: a systematic review. Clin Exp Med. 2023 Aug;23(4):1045-1054. doi: 10.1007/s10238-022-00855-8. Epub 2022 Aug 4. PubMed 35925475 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2025; primary completion for May 2026, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 3, 2025
First posted
Mar 7, 2025
StartEst.
May 1, 2025
Primary completionEst.
May 1, 2026
CompletionEst.
May 1, 2026
Last update
Mar 7, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06863454
Lead sponsor
Assiut University
Responsible party
Dina Abd El-nasser Attay (Principle investigator, Assiut University) — Principal investigator
First posted
Mar 7, 2025
Start date
May 1, 2025 (estimated)
Primary completion
May 1, 2026 (estimated)
Completion
May 1, 2026 (estimated)
Last update
Mar 7, 2025

Study contacts

Sara Mohamed Ibrahim Awad, Professor
Contact
saramawad@gmail.com
+201023102094

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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