Clinical trial NCT06158061: Assessment of Serum and Tissue Tryptase Levels in Acne Vulgaris Patients
Official title: Assessment of Serum and Tissue Tryptase Levels in Acne Vulgaris Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acne Vulgaris
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 .


Eligibility criteria: 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.

Primary outcomes:
measure: serum tryptase level
timeFrame: 8 months
measure: tissue tryptase level
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.