Assessment of Serum and Tissue Tryptase Levels in Acne Vulgaris Patients

Sohag University

Status: Not yet enrolling

Conditions: Acne Vulgaris

Treatments: Diagnostic Test: tryptase enzyme level

Study type: Interventional

Funder types: Other

Identifiers

NCT06158061

Soh-Med-23-11-04MS

Details and patient eligibility

About

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 .

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with acne vulgaris ≥ 18 years old, both male and female patients will be included.

Exclusion criteria

• 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

patient group

Active Comparator group

Description:

Patients with acne vulgaris ≥ 18 years old, both male and female patients will be included.

Treatment:

Diagnostic Test: tryptase enzyme level

control group

Active Comparator group

Description:

healthy controls without acne vulgaris or other dermatological diseases like psoriasis, vitiligo, DLE

Treatment:

Diagnostic Test: tryptase enzyme level