Assessment of Serum Catestatin Level in Acne Vulgaris Patients

NCT ID: NCT07054398

Last Updated: 2025-07-08

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-10

Study Completion Date

2026-01-10

Brief Summary

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Acne vulgaris is a persistent inflammatory condition of the pilosebaceous unit, affecting 85% of people between the ages of 12 and 24, it is regarded as one of the most common diseases in teenagers and young adults.

Catestatin, a peptide derived from chromogranin A (CgA), was first discovered in 1997 as an acute nicotinic-cholinergic antagonist. Later, it was determined that CST is a pleiotropic hormone.

Detailed Description

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Acne vulgaris is a persistent inflammatory condition of the pilosebaceous unit, affecting 85% of people between the ages of 12 and 24, it is regarded as one of the most common diseases in teenagers and young adults.

Four factors are thought to be linked to the physiopathology of acne: changes in the keratinization process of corneocytes, which results in the development of comedones; follicular proliferation of the bacterium Cutibacterium acnes; increased production of inflammatory mediators, including interleukins (IL)-1β; and increased sebum production by the sebaceous gland.

The distinctive lesions can be classified as either inflammatory (papules, pustules, nodules, and cysts) or non-inflammatory (open/black and closed/white comedones). Both types of lesions cause skin pigmentation and scarring, which need consistent treatment. Lesions are usually found on the chest, upper back, neck, and face.

There are wide variety of topical and oral therapy methods can be used for acne treatment. Topical retinoids, benzoyl peroxide, azelaic acid, and their combinations are considered first-line agents. Oral drugs such as oral antibiotics, isotretinoin, or hormonal therapy may be used to treat refractory or more severe acne.

The most effective treatment for acne is still isotretinoin (13-cis-retinoic acid), an oral retinoid that was licensed in 1982 for the treatment of acne vulgaris. Multiple randomized controlled trials have confirmed that it is more effective than oral antibiotics and placebos at reducing the number of acne lesions.

Oral isotretinoin is the only medication that can cure or prolong remission of moderate to severe acne , avoiding scarring and psychological effects. isotretinoin reduces the size of sebaceous glands, lowers sebum excretion, regulates cell proliferation, decreases keratinization, and modifies the follicles' microenvironment , resulting in a decrease in the number of Cutibacterium acnes. Furthermore, it has immunomodulatory and anti-inflammatory qualities by lowering the expression of monocyte TLR-2, lowering the inflammatory cytokine response, and having anti-neoplastic effects.

Antimicrobial peptides (AMP) have a wide spectrum of antibacterial and immunomodulatory properties against bacteria (Gram positive and Gram negative), viruses and fungi.

Variations in AMP expression in the skin could play a significant role in the pathogenesis of numerous skin conditions, such as acne vulgaris.

Catestatin, a peptide derived from chromogranin A (CgA), was first discovered in 1997 as an acute nicotinic-cholinergic antagonist. Later, it was determined that CST is a pleiotropic hormone.

Catestatin (CST), a versatile 21 amino acid long cationic peptide, derived from the processing of chromogranin A, catestatin is produced by chromaffin cells and neutrophils , retained in chromaffin granules, and produced in the skin upon damage.

Catestatin affects innate immunity, inflammation, blood pressure regulation, and catecholamine inhibition.

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group I (Study Group)

About 30 patients suffering from moderate and severe acne Vulgaris

Group Type ACTIVE_COMPARATOR

Isotretinoin

Intervention Type DRUG

* Measure the serum levels of catestatin in patients with moderate and severe acne vulgaris versus healthy control persons.
* Evaluate the effect of oral isotretinoin treatment on serum catestatin levels in patients with moderate and severe acne vulgaris.

Group II (Control Group)

About 30 Healthy persons

Group Type PLACEBO_COMPARATOR

Isotretinoin

Intervention Type DRUG

* Measure the serum levels of catestatin in patients with moderate and severe acne vulgaris versus healthy control persons.
* Evaluate the effect of oral isotretinoin treatment on serum catestatin levels in patients with moderate and severe acne vulgaris.

Interventions

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Isotretinoin

* Measure the serum levels of catestatin in patients with moderate and severe acne vulgaris versus healthy control persons.
* Evaluate the effect of oral isotretinoin treatment on serum catestatin levels in patients with moderate and severe acne vulgaris.

Intervention Type DRUG

Other Intervention Names

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Catestatin

Eligibility Criteria

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Inclusion Criteria

* Healthy persons of both sexes with moderate and severe acne.

Exclusion Criteria

* Pregnant and lactating women.
* Immunocompromised patients.
* Severe anemia.
* History of chronic liver disease.
* Hyperlipidemia
* Non-inflammatory acne conditions.
* History of neurologic disorders.
* History of neoplastic disorders.
* History of cardiac disease.
* History of systemic acne treatment for at least 4 weeks prior to inclusion and no topical treatments for at least 2 weeks.
* Cases with known hypersensitivity reaction to isotretinoin.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aswan University

OTHER

Sponsor Role lead

Responsible Party

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Mona Zakaria Mohamed

Resident of Dermatology, at Faculty of medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Moustafa Adam Ali El Taieb, Professor

Role: STUDY_CHAIR

Dermatology, Venereology and Andrology. Faculty of Medicine,Aswan University

Locations

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Aswan Unuversity Hospital

Aswān, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mona Zakaria Mohamed, MSc

Role: CONTACT

+201142550119

Facility Contacts

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Mahmoud Ahmed Ali, M.D

Role: primary

+201002364902

Mohamed Amer Ahmed Abdellatif, M.D

Role: backup

+201060394083

Other Identifiers

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Serum Catestatin

Identifier Type: -

Identifier Source: org_study_id

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