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Assessment of Serum and Tissue Tryptase Levels in Acne Vulgaris Patients

NCT06158061 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-12-06

No results posted yet for this study

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 .

Conditions

  • Acne Vulgaris

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Sohag University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-24
Primary Completion
2024-08-15
Completion
2024-08-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06158061 on ClinicalTrials.gov