Assessment of Serum Catestatin Level in Acne Vulgaris Patients

NCT07054398 | Recruiting DMC

• 1 other identifier: Serum Catestatin
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• Evalaute serum level of Catestatin in acne patient

  Assessment of clinical improvement according to:(8) G4(excellent:100% reduction) G3(good:75-99% reduction) G2(moderate: 50-74% reduction) G1(insufficient :1-49% reduction) G0(unchanged) G-1(worse)

  12 weeks

• Evalaute the effect of treatment with systemic isotretinon

  Evaluate the effect of treatment with systemic isotretinon therapy (0.5 mg/kg/day, up to 40 mg daily) on the level of serum Catestatin on the Participants whom suffering from Acne Vulgaris whether moderate or severe.

  12 weeks

Study Arms (2)

Group I (Study Group)

ACTIVE COMPARATOR

About 30 patients suffering from moderate and severe acne Vulgaris

Drug: Isotretinoin

Group II (Control Group)

PLACEBO COMPARATOR

About 30 Healthy persons

Drug: Isotretinoin

Interventions

Isotretinoin 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.

Also known as: Catestatin

Group I (Study Group); Group II (Control Group)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• Cases with known hypersensitivity reaction to isotretinoin.

Sponsors & Collaborators

• Aswan University: lead

Study Sites (1)

Aswan Unuversity Hospital

Aswān, Egypt

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Isotretinoin; chromogranin A (344-364)

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Moustafa Adam Ali El Taieb, Professor

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

  STUDY CHAIR

Central Study Contacts

Mona Zakaria Mohamed, MSc

CONTACT

+201142550119; mona1704213@aswu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Dermatology, at Faculty of medicine

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: July 8, 2025
• Study Start: January 10, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 10, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-01

Locations

EG (1)