Assessment of Serum and Tissue Tryptase Levels in Acne Vulgaris Patients
- Conditions
- Acne Vulgaris
- Interventions
- Diagnostic Test: tryptase enzyme level
- Registration Number
- NCT06158061
- Lead Sponsor
- Sohag University
- Brief Summary
Acne vulgaris is an inflammatory disorder of pilosebaceous glands. Acne is a highly prevalent inflammatory disease affecting approximately 9.4% of the world's population , and estimated up to 90% among adolescents. By natural course acne starts at 7-12 ages and mostly resolves by the third decade of individuals life .
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
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 90
- Patients with acne vulgaris ≥ 18 years old, both male and female patients will be included.
- Patients with the following criteria will be excluded from our study: 1- Pregnancy and breast feeding women. 2- Women on hormonal contraceptions. 3- Patients on topical/systemic treatment for AV during the last 6 months prior to the study. 4- Patients with other dermatological diseases e.g. psoriasis, vitiligo, DLE, etc. 5- Patients suffering from chronic medical illness such as; diabetes mellitus, thyroid disease, and cancer.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group tryptase enzyme level healthy controls without acne vulgaris or other dermatological diseases like psoriasis, vitiligo, DLE patient group tryptase enzyme level Patients with acne vulgaris ≥ 18 years old, both male and female patients will be included.
- Primary Outcome Measures
Name Time Method tissue tryptase level 8 months 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.
serum tryptase level 8 months 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sohag university Hospital
🇪🇬Sohag, Egypt