Assessment of Serum and Tissue Tryptase Levels in Acne Vulgaris Patients
NCT ID: NCT06158061
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
90 participants
INTERVENTIONAL
2024-01-24
2024-08-15
Brief Summary
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Mast cells may play important role in maintenance of physiological functions of our body; they also have a role in pathological and inflammatory mechanisms of many diseases. Tryptase is suggested to be important for survival as no tryptase-deficient human subject has yet been reported. Tryptase is mainly synthesized by mast cells but a very low amount may originate in basophil with no interference with total levels of the enzyme. Tryptase is currently considered as a metabolic signaling and effector mediator for acute mast cell degranulation and late phase of allergy and inflammation .
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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patient group
Patients with acne vulgaris ≥ 18 years old, both male and female patients will be included.
tryptase enzyme level
In serum:
Three ml blood will be collected from all participants (patients and controls) by aseptic venipuncture into redtop plain glass tubes. Blood samples will be allowed to coagulate during 30-60 minutes. Serum will be obtained by centrifugation at t 1262 g for 10 minutes, aliquoted, and immediately frozen at -20°C until analyzed to determine serum tryptase level. Serum tryptase concentration will be assessed by a commercially available double antibody sandwich enzyme-linked immunosorbent assay (ELISA) kit.
In tissue:
Punch skin biopsies of 3mm depth will be taken under local anesthesia from back of Acne vulgaris patients and from matched sites of control subjects. Skin biopsies will be fixed in 10% formalin solution, and submitted to Pathology department in our institute for routine tissue processing by special stain for assessment of tissue tryptase level and number of mast cells tissue biopsy.
control group
healthy controls without acne vulgaris or other dermatological diseases like psoriasis, vitiligo, DLE
tryptase enzyme level
In serum:
Three ml blood will be collected from all participants (patients and controls) by aseptic venipuncture into redtop plain glass tubes. Blood samples will be allowed to coagulate during 30-60 minutes. Serum will be obtained by centrifugation at t 1262 g for 10 minutes, aliquoted, and immediately frozen at -20°C until analyzed to determine serum tryptase level. Serum tryptase concentration will be assessed by a commercially available double antibody sandwich enzyme-linked immunosorbent assay (ELISA) kit.
In tissue:
Punch skin biopsies of 3mm depth will be taken under local anesthesia from back of Acne vulgaris patients and from matched sites of control subjects. Skin biopsies will be fixed in 10% formalin solution, and submitted to Pathology department in our institute for routine tissue processing by special stain for assessment of tissue tryptase level and number of mast cells tissue biopsy.
Interventions
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tryptase enzyme level
In serum:
Three ml blood will be collected from all participants (patients and controls) by aseptic venipuncture into redtop plain glass tubes. Blood samples will be allowed to coagulate during 30-60 minutes. Serum will be obtained by centrifugation at t 1262 g for 10 minutes, aliquoted, and immediately frozen at -20°C until analyzed to determine serum tryptase level. Serum tryptase concentration will be assessed by a commercially available double antibody sandwich enzyme-linked immunosorbent assay (ELISA) kit.
In tissue:
Punch skin biopsies of 3mm depth will be taken under local anesthesia from back of Acne vulgaris patients and from matched sites of control subjects. Skin biopsies will be fixed in 10% formalin solution, and submitted to Pathology department in our institute for routine tissue processing by special stain for assessment of tissue tryptase level and number of mast cells tissue biopsy.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Sohag University
OTHER
Responsible Party
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Mariam Magdy Mounir
resident in dermatology department of Sohag Psychiatric hospital
Locations
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Sohag university Hospital
Sohag, , Egypt
Countries
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Central Contacts
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Mohammed A Ali, professor
Role: CONTACT
Facility Contacts
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Magdy M Amin, professor
Role: primary
References
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Alanazi MS, Hammad SM, Mohamed AE. Prevalence and psychological impact of Acne vulgaris among female secondary school students in Arar city, Saudi Arabia, in 2018. Electron Physician. 2018 Aug 25;10(8):7224-7229. doi: 10.19082/7224. eCollection 2018 Aug.
Saleh HM, Deif MA, El-Husseiny RM. Assessment of serum interleukin-19 in acne vulgaris patients of different clinical severities. J Cosmet Dermatol. 2021 Sep;20(9):3034-3040. doi: 10.1111/jocd.13977. Epub 2021 Feb 13.
Jusuf NK, Putra IB, Sari L. Differences of Microbiomes Found in Non-Inflammatory and Inflammatory Lesions of Acne Vulgaris. Clin Cosmet Investig Dermatol. 2020 Oct 22;13:773-780. doi: 10.2147/CCID.S272334. eCollection 2020.
Tang L, Yu B, Liao Y, Long S, Yan H, He Q, Li C. Serum Irisin: A Potential Diagnostic Marker for Insulin Resistance in Acne Vulgaris. Indian J Dermatol. 2022 Jul-Aug;67(4):477. doi: 10.4103/ijd.ijd_251_22.
Other Identifiers
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Soh-Med-23-11-04MS
Identifier Type: -
Identifier Source: org_study_id