Oral Lesions in Patients With Pemphigus VulgarisNCT07641725

Comparison of the Efficacy of Clobetasol Propionate 0.05% Mouthwash, Photobiomodulation, and Their Combination in Managing of Oral Lesions in Patient With Pemphigus Vulgaris.

A study testing Clobetasol propionate 0.05% Mouthwash, diode laser for photobiomodulation and clobetasol propionate 0.05% mouthwash + photobiomodulation in people with Oral Lesions in Patients With Pemphigus Vulgaris, run by Damascus University at 1 site in Syria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Oral Lesions in Patients With Pemphigus Vulgaris
What is being tested?: Clobetasol propionate 0.05% Mouthwash, diode laser for photobiomodulation and clobetasol propionate 0.05% mouthwash + photobiomodulation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteSyria
Study dates: 1 Nov 2025to 1 Dec 2026
Phase: Interventional
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Confirmed diagnosis of Pemphigus Vulgaris based on clinical presentation, histopathology, and immunopathological findings (positive direct and indirect immunofluorescence), according to World Health Organization (WHO) standards.
Presence of active erosive or ulcerative oral lesions with a maximum diameter exceeding 1 cm.
Patients currently maintained on a stable systemic corticosteroid regimen not exceeding 1 mg/kg/day.

Who cannot join

Co-existing chronic systemic conditions, including significant gastrointestinal disorders or uncontrolled diabetes mellitus.
History or current evidence of malignancy.
Concurrent use of systemic antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs), or hormonal therapies that may interfere with the study outcomes.
Pregnancy or active lactation. Note: These criteria are strictly enforced to ensure that the study population remains homogeneous regarding the systemic treatment protocol.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alaa Alhomsi, DDS,MSc,PhD Student contact

00963993837778

allaalhomsi1@gmail.com

Syria1 site, 1 recruiting

Department of Oral Medicine, Faculty of Dental medicine
Damascus
Abeer Aljoujou, PhD in oral medicine, 00963944703131, abeerjoujou@gmail.com
Alaa Alhomsi, Phd student in oral medicine
Recruiting

Other trials in Syria

About this study

Official title: Evaluation of the Effectiveness of Clobetasol Propionate 0.05% and Photobiomodulation in the Management of Oral Lesions in Patients With Pemphigus Vulgaris. (Three-arm Randomized Controlled Clinical Study)

Pemphigus vulgaris (PV) is a chronic, potentially life-threatening autoimmune mucocutaneous disorder that significantly impairs patients' quality of life. While systemic corticosteroids and immunosuppressants remain the standard of care, many patients suffer from persistent, painful oral lesions that exhibit delayed healing or poor response to conventional systemic protocols. This clinical trial investigates the efficacy and safety of supportive topical interventions: clobetasol propionate 0.05% mouthwash and photobiomodulation therapy (PBMT)-a non-invasive approach designed to accelerate tissue repair, and their combination. The primary objective is to identify effective adjunctive topical therapies that can facilitate the healing of oral erosions, mitigate pain, and potentially allow for a reduction in systemic medication dosages, thereby minimizing long-term treatment-related complications and improving overall patient outcomes.

Read the detailed description

Patients with pemphigus vulgaris often experience debilitating oral pain, which severely restricts their ability to maintain adequate nutrition and hydration. Furthermore, the presence of extensive oral ulcers and erosions poses a significant risk for secondary bacterial or fungal infections. These challenges underscore the clinical necessity for effective topical adjunctive treatments to complement systemic therapy. By enhancing local lesion management, these topical modalities aim to accelerate clinical.

Conditions: Oral Lesions in Patients With Pemphigus Vulgaris
Being tested: Clobetasol propionate 0.05% Mouthwash, diode laser for photobiomodulation, clobetasol propionate 0.05% mouthwash + photobiomodulation
Keywords: Pemphigus vulgaris - Photobiomodulation - Clobetasol propionate - Autoimmune Blistering Diseases.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Clobetasol propionate 0.05% MouthwashDrug
Participants will receive topical clobetasol propionate 0.05% mouthwash
diode laser for photobiomodulationDevice
Participants will receive photobiomodulation therapy (low-level laser therapy) by diode laser.
clobetasol propionate 0.05% mouthwash + photobiomodulationDrug
Participants will receive combined treatment with topical clobetasol propionate 0.05% mouthwash and photobiomodulation therapy (low-level laser therapy) by diode laser.

Study groups in NCT07641725
Study group	Role	What they receive
Arm 1: Clobetasol propionate 0.05% Mouthwash	Experimental	Drug: Clobetasol propionate 0.05% mouthwash * Use 3 times daily. * Rinse and hold in the mouth for 3 minutes per application. * Do not swallow. * Duration: 4 weeks. Follow-up instructions: After 4 weeks of therapy, if the patient achieves complete clinical remission, taper the frequency gradually until discontinuation, similar to the tapering of systemic steroids (e.g., reduce from three times daily → twice daily → once daily → every other day → stop). Receives: Drug: Clobetasol propionate 0.05% Mouthwash
Arm 2: Photobiomodulation Therapy	Experimental	Patients in the laser group received photobiomodulation therapy using a 650 nm diode laser (continuous wave mode). The laser parameters were as follows: * Wavelength: 650 nm * Output power: 100 mW * Mode: Continuous wave * Radiant exposure (energy density): 4 J/cm² per session * Exposure duration: 20 seconds per session (adjusted according to the spot size/area of the lesion to achieve the target fluence of 4 J/cm²) Treatment was applied without contact by maintaining a distance of 1 mm from the lesion and making continuous circular movements from the periphery toward the center of the lesions. Sessions were performed twice a week for a total duration of 30 days (approximately 8-9 sessions, depending on the exact scheduling). Receives: Device: diode laser for photobiomodulation
Arm 3: Combination Therapy	Experimental	All patients in the intervention arm received combined treatment consisting of: Clobetasol propionate 0.05% mouthwash, rinsed three times daily for 3 minutes each time, for 30 days, in addition to photobiomodulation therapy using a 650 nm diode laser (continuous mode, 100 mW, 4 J/cm², 20 seconds per session). The laser therapy was administered twice weekly for 30 days. Treatments were performed by a trained clinician according to standardized protocol. Receives: Drug: Clobetasol propionate 0.05% Mouthwash; Drug: clobetasol propionate 0.05% mouthwash + photobiomodulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Pemphigus Disease Area Index (PDAI)
The PDAI is a validated clinical scoring system used to assess disease activity in pemphigus vulgaris. It evaluates the extent and severity of skin and mucosal lesions, including lesion number and size. Higher scores indicate more severe disease activity.
These scores are categorized as follows:
250 points associated with disease activity, distributed as follows:
- 120 points for the skin
- 120 points for the mucous membranes
- 10 points for the scalp. 30 points for tissue damage Disease activity, as well as the number and size of lesions in each specific region, are considered crucial factors within this scoring system.
In the context of this research, only the component assessing oral mucosal involvement will be utilized.
Measured: Patients will be followed up on Days 7, 14, 21, 28, 42, 60, and 90
Oral Disease Severity Score (ODSS)
The ODSS is a site-specific scoring system designed to assess the severity of oral mucosal involvement in pemphigus vulgaris. It quantifies the number, size, and distribution of oral lesions, as well as their functional impact on pain and eating ability.
The total score is 106 points, calculated by summing the region score, the disease activity score, and the pain score.
Measured: Patients will be followed up on Days 7, 14, 21, 28, 42, 60, and 90
Autoimmune Bullous Skin Disorder Intensity Score (ABSIS)
The ABSIS is a composite score used to assess disease severity in autoimmune blistering disorders. It includes evaluation of the extent of skin and mucosal involvement and incorporates patient-reported symptoms such as pain and difficulty in eating. It provides both objective and subjective measures of disease severity.
The overall assessment consists of a total score of 208 points (100 points for skin lesions, 100 points for oral lesions, and 8 points for self-reported discomfort during eating). In this study, only the oral mucosal component of the score will be used.
This component evaluates 20 distinct anatomical sites in the oral cavity. A score of 0 (absence of any lesion) or 1 (presence of a lesion) is assigned to each site, resulting in a maximum score of 20 points for the extent of oral lesions.
The second part of the score is dedicated to symptom severity. It details the degree of discomfort experienced while eating and drinking, with a maximum score of 10 points
Measured: Patients will be followed up on Days 7, 14, 21, 28, 42, 60, and 90
physician Global Assessment (PGA)
The PGA is a clinician-reported global measure of overall disease severity and activity. It is based on the physician's overall clinical judgment, integrating physical examination findings and disease extent into a single numerical score.
It consists of a 10-point visual analogue scale (VAS) that ranges from 0 (representing ideal health or complete clearance) to 10 (representing the worst possible disease state). Physicians rate the patient according to their global clinical impression of the disease severity.
Measured: Patients will be followed up on Days 7, 14, 21, 28, 42, 60, and 90

Secondary outcomes (4)

Systemic Corticosteroid Dosage During Treatment of Oral Lesions
One of the inclusion criteria requires that the patient is on a systemic corticosteroid dose that does not exceed 1 mg/kg/day. During the study, the systemic corticosteroid dose will be assessed whenever the dermatologist decides to reduce it in response to improvement of the oral lesions' symptoms.
Measured: in day 30,60,90
Oral Health Impact Profile-14 (OHIP-14)
The Oral Health Impact Profile-14 (OHIP-14) is a widely used, short-form questionnaire designed to measure the impact of oral health problems on an individual's oral health-related quality of life (OHRQoL).
Measured: Patients will be followed up before the treatment and on Days 30,60,90
Hamilton Anxiety Rating Scale (HAM-A)
The HAM-A is a 14-item clinician-rated scale that assesses the severity of anxiety symptoms over the past week. It covers both psychic anxiety (mental agitation, psychological distress, fears, and mood) and somatic anxiety (physical manifestations such as cardiovascular, respiratory, gastrointestinal, genitourinary, and muscular symptoms).
Each item is scored on a 5-point Likert-type scale ranging from 0 (not present) to 4 (severe/incapacitating). The total score ranges from 0 to 56
Measured: before the treatment and after in days 30,60,90
Hamilton Depression Rating Scale (HAM-D)
The HAM-D (most commonly the 17-item version) is one of the most established clinician-administered scales for assessing the severity of depressive symptoms over the past week. It evaluates core domains including depressed mood, feelings of guilt, suicidal ideation, insomnia, psychomotor agitation or retardation, anxiety, somatic symptoms, and loss of interest or energy.
Items are scored on either a 3-point (0-2) or 5-point (0-4) scale, depending on the item, with a total score range of 0 to 52 (for the 17-item version).
Measured: before the treatment and after in days 30,60,90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20251 Dec 2026

First posted11 Jun 2026
Study start1 Nov 2025
Primary completion1 Sep 2026 (estimated)
Study completion1 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Oral Lesions in Patients With Pemphigus VulgarisStudies 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
Masking: Single blind
Who is masked: Participant
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07641725
Sponsor's protocol ID: DN-230226-647
Status last verified: Jun 2026
First submitted: 8 Jun 2026
Last updated: 11 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Chen G, Yang B, Zhang Z, Yang Q, Yan X, Murrell DF, Zhang F. Chinese version of the treatment of autoimmune bullous disease quality of life questionnaire: Reliability and validity. Indian J Dermatol Venereol Leprol. 2018 Jul-Aug;84(4):431-436. doi: 10.4103/ijdvl.IJDVL_538_16.
PubMed 28485307
Noce CW, Gomes A, Shcaira V, Correa ME, Moreira MC, Silva Junior A, Goncalves LS, Garnica M, Maiolino A, Torres SR. Randomized double-blind clinical trial comparing clobetasol and dexamethasone for the topical treatment of symptomatic oral chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2014 Aug;20(8):1163-8. doi: 10.1016/j.bbmt.2014.04.009. Epub 2014 Apr 13.
PubMed 24727333
Murrell DF, Caux F, Prost-Squarcioni C. Is the Oral Disease Severity Score going to be useful for dermatologists when assessing pemphigus? Br J Dermatol. 2018 Oct;179(4):816-817. doi: 10.1111/bjd.16911. No abstract available.
PubMed 30318808
Lara RN, da Guerra EN, de Melo NS. Macroscopic and microscopic effects of GaAIAs diode laser and dexamethasone therapies on oral mucositis induced by fluorouracil in rats. Oral Health Prev Dent. 2007;5(1):63-71.
PubMed 17366763
Jindal A, Rao C, Pai SB, Rao R. Utility of oral mucosa as a substrate for the serodiagnosis of pemphigus: A descriptive analysis. Indian J Dermatol Venereol Leprol. 2022 Mar-Apr;88(2):156-161. doi: 10.25259/IJDVL_469_20.
PubMed 34491669
Harman KE, Brown D, Exton LS, Groves RW, Hampton PJ, Mohd Mustapa MF, Setterfield JF, Yesudian PD. British Association of Dermatologists' guidelines for the management of pemphigus vulgaris 2017. Br J Dermatol. 2017 Nov;177(5):1170-1201. doi: 10.1111/bjd.15930. No abstract available.
PubMed 29192996
Gonzalez-Moles MA, Morales P, Rodriguez-Archilla A, Isabel IR, Gonzalez-Moles S. Treatment of severe chronic oral erosive lesions with clobetasol propionate in aqueous solution. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 Mar;93(3):264-70. doi: 10.1067/moe.2002.120522.
PubMed 11925534
de Macedo AG, Bertges ER, Bertges LC, Mendes RA, Bertges TABS, Bertges KR, Aarestrup FM. Pemphigus Vulgaris in the Mouth and Esophageal Mucosa. Case Rep Gastroenterol. 2018 Jun 15;12(2):260-265. doi: 10.1159/000489299. eCollection 2018 May-Aug.
PubMed 30022914
Dal Pra KJ, de Assis Tristao SDSS, Franco JB, Matias DT, Carrillo CM, de Melo Peres MPS, Ribas PF. Oral management of pemphigus vulgaris in the intensive care unit. Spec Care Dentist. 2020 May;40(3):280-284. doi: 10.1111/scd.12454. Epub 2020 Mar 12.
PubMed 32162360
Amadori F, Bardellini E, Veneri F, Majorana A. Photobiomodulation laser therapy in pemphigus vulgaris oral lesions: A randomized, double-blind, controlled study. Stomatologija. 2022;24(3):80-84.
PubMed 37140257
ALhomsi A, Aljoujou AA, Mashlah A, Al Ahdab S, Al Jabban H. Combined treatment of dexamethasone mouthwash and low-level laser therapy in the management of aphthous-like ulcers caused by nonsteroidal anti-inflammatory drugs: A case report. Clin Case Rep. 2024 Mar 27;12(4):e8723. doi: 10.1002/ccr3.8723. eCollection 2024 Apr.
PubMed 38550731

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Effectiveness of Clobetasol Propionate 0.05% and Photobiomodulation in the Management of Oral Lesions in Patients With Pemphigus Vulgaris. (Three-arm Randomized Controlled Clinical Study)
ClinicalTrials.gov ID: NCT07641725
Acronym / sponsor ID: DN-230226-647
Conditions: Oral Lesions in Patients With Pemphigus Vulgaris
Keywords: Pemphigus vulgaris - Photobiomodulation - Clobetasol propionate - Autoimmune Blistering Diseases.
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 30 participants (estimated)
Lead sponsor: Damascus UniversityUniversity, hospital or other
Study start: 1 Nov 2025 (actual)
Primary completion: 1 Sep 2026 (estimated)
Study completion: 1 Dec 2026 (estimated)
First posted: 11 Jun 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Arm 1: Clobetasol propionate 0.05% Mouthwash	Experimental	Drug: Clobetasol propionate 0.05% MouthwashDrug: Clobetasol propionate 0.05% mouthwash * Use 3 times daily. * Rinse and hold in the mouth for 3 minutes per application. * Do not swallow. * Duration: 4 weeks. Follow-up instructions: After 4 weeks of therapy, if the patient achieves complete clinical remission, taper the frequency gradually until discontinuation, similar to the tapering of systemic steroids (e.g., reduce from three times daily → twice daily → once daily → every other day → stop).
Arm 2: Photobiomodulation Therapy	Experimental	Device: diode laser for photobiomodulationPatients in the laser group received photobiomodulation therapy using a 650 nm diode laser (continuous wave mode). The laser parameters were as follows: * Wavelength: 650 nm * Output power: 100 mW * Mode: Continuous wave * Radiant exposure (energy density): 4 J/cm² per session * Exposure duration: 20 seconds per session (adjusted according to the spot size/area of the lesion to achieve the target fluence of 4 J/cm²) Treatment was applied without contact by maintaining a distance of 1 mm from the lesion and making continuous circular movements from the periphery toward the center of the lesions. Sessions were performed twice a week for a total duration of 30 days (approximately 8-9 sessions, depending on the exact scheduling).
Arm 3: Combination Therapy	Experimental	Drug: Clobetasol propionate 0.05% Mouthwash, Drug: clobetasol propionate 0.05% mouthwash + photobiomodulationAll patients in the intervention arm received combined treatment consisting of: Clobetasol propionate 0.05% mouthwash, rinsed three times daily for 3 minutes each time, for 30 days, in addition to photobiomodulation therapy using a 650 nm diode laser (continuous mode, 100 mW, 4 J/cm², 20 seconds per session). The laser therapy was administered twice weekly for 30 days. Treatments were performed by a trained clinician according to standardized protocol.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Confirmed diagnosis of Pemphigus Vulgaris based on clinical presentation, histopathology, and immunopathological findings (positive direct and indirect immunofluorescence), according to World Health Organization (WHO) standards.
Presence of active erosive or ulcerative oral lesions with a maximum diameter exceeding 1 cm.
Patients currently maintained on a stable systemic corticosteroid regimen not exceeding 1 mg/kg/day.

Key exclusion criteria (4 listed)

Co-existing chronic systemic conditions, including significant gastrointestinal disorders or uncontrolled diabetes mellitus.
History or current evidence of malignancy.
Concurrent use of systemic antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs), or hormonal therapies that may interfere with the study outcomes.
Pregnancy or active lactation. Note: These criteria are strictly enforced to ensure that the study population remains homogeneous regarding the systemic treatment protocol.

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
Clobetasol propionate 0.05% MouthwashParticipants will receive topical clobetasol propionate 0.05% mouthwash	Drug	Arm 1: Clobetasol propionate 0.05% Mouthwash, Arm 3: Combination Therapy
diode laser for photobiomodulationParticipants will receive photobiomodulation therapy (low-level laser therapy) by diode laser.	Device	Arm 2: Photobiomodulation Therapy
clobetasol propionate 0.05% mouthwash + photobiomodulationParticipants will receive combined treatment with topical clobetasol propionate 0.05% mouthwash and photobiomodulation therapy (low-level laser therapy) by diode laser.	Drug	Arm 3: Combination Therapy

Primary outcome

Pemphigus Disease Area Index (PDAI)
Time frame: Patients will be followed up on Days 7, 14, 21, 28, 42, 60, and 90
The PDAI is a validated clinical scoring system used to assess disease activity in pemphigus vulgaris. It evaluates the extent and severity of skin and mucosal lesions, including lesion number and size. Higher scores indicate more severe disease activity. These scores are categorized as follows: 250 points associated with disease activity, distributed as follows: * 120 points for the skin * 120 points for the mucous membranes * 10 points for the scalp. 30 points for tissue damage Disease activity, as well as the number and size of lesions in each specific region, are considered crucial factors within this scoring system. In the context of this research, only the component assessing oral mucosal involvement will be utilized.
Oral Disease Severity Score (ODSS)
Time frame: Patients will be followed up on Days 7, 14, 21, 28, 42, 60, and 90
The ODSS is a site-specific scoring system designed to assess the severity of oral mucosal involvement in pemphigus vulgaris. It quantifies the number, size, and distribution of oral lesions, as well as their functional impact on pain and eating ability. The total score is 106 points, calculated by summing the region score, the disease activity score, and the pain score.
Autoimmune Bullous Skin Disorder Intensity Score (ABSIS)
Time frame: Patients will be followed up on Days 7, 14, 21, 28, 42, 60, and 90
The ABSIS is a composite score used to assess disease severity in autoimmune blistering disorders. It includes evaluation of the extent of skin and mucosal involvement and incorporates patient-reported symptoms such as pain and difficulty in eating. It provides both objective and subjective measures of disease severity. The overall assessment consists of a total score of 208 points (100 points for skin lesions, 100 points for oral lesions, and 8 points for self-reported discomfort during eating). In this study, only the oral mucosal component of the score will be used. This component evaluates 20 distinct anatomical sites in the oral cavity. A score of 0 (absence of any lesion) or 1 (presence of a lesion) is assigned to each site, resulting in a maximum score of 20 points for the extent of oral lesions. The second part of the score is dedicated to symptom severity. It details the degree of discomfort experienced while eating and drinking, with a maximum score of 10 points
physician Global Assessment (PGA)
Time frame: Patients will be followed up on Days 7, 14, 21, 28, 42, 60, and 90
The PGA is a clinician-reported global measure of overall disease severity and activity. It is based on the physician's overall clinical judgment, integrating physical examination findings and disease extent into a single numerical score. It consists of a 10-point visual analogue scale (VAS) that ranges from 0 (representing ideal health or complete clearance) to 10 (representing the worst possible disease state). Physicians rate the patient according to their global clinical impression of the disease severity.

4 secondary outcomes

Systemic Corticosteroid Dosage During Treatment of Oral Lesions
Time frame: in day 30,60,90
Oral Health Impact Profile-14 (OHIP-14)
Time frame: Patients will be followed up before the treatment and on Days 30,60,90
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: before the treatment and after in days 30,60,90
Hamilton Depression Rating Scale (HAM-D)
Time frame: before the treatment and after in days 30,60,90

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 11 Jun 2026.
Background: PubMed 28485307Chen G, Yang B, Zhang Z, Yang Q, Yan X, Murrell DF, Zhang F. Chinese version of the treatment of autoimmune bullous disease quality of life questionnaire: Reliability and validity. Indian J Dermatol Venereol Leprol. 2018 Jul-Aug;84(4):431-436. doi: 10.4103/ijdvl.IJDVL_538_16.
Background: PubMed 24727333Noce CW, Gomes A, Shcaira V, Correa ME, Moreira MC, Silva Junior A, Goncalves LS, Garnica M, Maiolino A, Torres SR. Randomized double-blind clinical trial comparing clobetasol and dexamethasone for the topical treatment of symptomatic oral chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2014 Aug;20(8):1163-8. doi: 10.1016/j.bbmt.2014.04.009. Epub 2014 Apr 13.
Background: PubMed 30318808Murrell DF, Caux F, Prost-Squarcioni C. Is the Oral Disease Severity Score going to be useful for dermatologists when assessing pemphigus? Br J Dermatol. 2018 Oct;179(4):816-817. doi: 10.1111/bjd.16911. No abstract available.
Background: PubMed 17366763Lara RN, da Guerra EN, de Melo NS. Macroscopic and microscopic effects of GaAIAs diode laser and dexamethasone therapies on oral mucositis induced by fluorouracil in rats. Oral Health Prev Dent. 2007;5(1):63-71.
Background: PubMed 34491669Jindal A, Rao C, Pai SB, Rao R. Utility of oral mucosa as a substrate for the serodiagnosis of pemphigus: A descriptive analysis. Indian J Dermatol Venereol Leprol. 2022 Mar-Apr;88(2):156-161. doi: 10.25259/IJDVL_469_20.
Background: PubMed 29192996Harman KE, Brown D, Exton LS, Groves RW, Hampton PJ, Mohd Mustapa MF, Setterfield JF, Yesudian PD. British Association of Dermatologists' guidelines for the management of pemphigus vulgaris 2017. Br J Dermatol. 2017 Nov;177(5):1170-1201. doi: 10.1111/bjd.15930. No abstract available.
Background: PubMed 11925534Gonzalez-Moles MA, Morales P, Rodriguez-Archilla A, Isabel IR, Gonzalez-Moles S. Treatment of severe chronic oral erosive lesions with clobetasol propionate in aqueous solution. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 Mar;93(3):264-70. doi: 10.1067/moe.2002.120522.
Background: PubMed 30022914de Macedo AG, Bertges ER, Bertges LC, Mendes RA, Bertges TABS, Bertges KR, Aarestrup FM. Pemphigus Vulgaris in the Mouth and Esophageal Mucosa. Case Rep Gastroenterol. 2018 Jun 15;12(2):260-265. doi: 10.1159/000489299. eCollection 2018 May-Aug.
Background: PubMed 32162360Dal Pra KJ, de Assis Tristao SDSS, Franco JB, Matias DT, Carrillo CM, de Melo Peres MPS, Ribas PF. Oral management of pemphigus vulgaris in the intensive care unit. Spec Care Dentist. 2020 May;40(3):280-284. doi: 10.1111/scd.12454. Epub 2020 Mar 12.
Background: PubMed 37140257Amadori F, Bardellini E, Veneri F, Majorana A. Photobiomodulation laser therapy in pemphigus vulgaris oral lesions: A randomized, double-blind, controlled study. Stomatologija. 2022;24(3):80-84.
Background: PubMed 38550731ALhomsi A, Aljoujou AA, Mashlah A, Al Ahdab S, Al Jabban H. Combined treatment of dexamethasone mouthwash and low-level laser therapy in the management of aphthous-like ulcers caused by nonsteroidal anti-inflammatory drugs: A case report. Clin Case Rep. 2024 Mar 27;12(4):e8723. doi: 10.1002/ccr3.8723. eCollection 2024 Apr.
Individual participant dataSharing planned: No

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.

Alaa Alhomsi, DDS,MSc,PhD Student contact

00963993837778

allaalhomsi1@gmail.com

Abeer Aljoujou, PhD In Oral medicine principal investigator

Associate Professor, Department of Oral Medicine, Faculty of Dental medicine, Damascus University, Damascus, Syria.

Nemat Alsaghir, PhD in dermatology principal investigator

Lecturer, Department of Dermatology, Faculty of Medicine, Damascus University, Damascus, Syria.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 Jun 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 Syria. 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?

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 Alaa Alhomsi, DDS,MSc,PhD Student (00963993837778, allaalhomsi1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pemphigus Disease Area Index (PDAI) (time frame: Patients will be followed up on Days 7, 14, 21, 28, 42, 60, and 90). The study lists 4 primary outcomes in all. 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 NCT07641725, which also lists 11 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 11 Jun 2026.