Effect of Systemic Isotretinoin on Serum Irisin Level in Acne Vulgaris Patients

NCT05869188 | Completed DMC

• 1 other identifier: Nahed Abouelwfa
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Acne vulgaris is a chronic inflammatory skin disease affecting the pilosebaceous unit. It is clinically characterized by comedones, papules, pustules, nodules, cysts and scarring on the face and trunk. The severity of the disease ranges from mild comedonal acne to severe nodulocystic acne which can be permanently disfiguring.In addition to the physical lesions, the disease can have a profound psychologic impact, contributing to low self-esteem, depression and anxiety.In addition to the physical lesions, the disease can have a profound psychologic impact, contributing to low self-esteem, depression and anxiety.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Evalaute serum level of irisin 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)

  From 0 base to 3 Months from starting the treatment Day

Secondary Outcomes (1)

• Evalaute the effect of treatment with systemic isotretinon

  From 0 base to 3 Months from starting the treatment Day

Study Arms (3)

Pateints with Moderate Acne

ACTIVE COMPARATOR

20 patients affected by Acne and More than half of the face is involved. Many papules and pustules, many open or closed comedones. One nodule may be present.

Drug: Isotretinoin

Pateints with Severe Acne

ACTIVE COMPARATOR

20 patients affected by Acne and Entire face is involved, covered with many papules and pustules, open or closed comedones and rare nodules

Drug: Isotretinoin

control

ACTIVE COMPARATOR

20 Health participants

Drug: Isotretinoin

Interventions

Isotretinoin DRUG

* Evaluate serum irisin level in acne vulgaris and compare it with healthy control . * Evaluate the effect of systemic isotretinoin on serum irisin in acne vulgaris patients .

Also known as: irisin

Pateints with Moderate Acne; Pateints with Severe Acne; control

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Cases with moderate and severe acne.
• Clinical diagnosis of acne Disease
• Patient not receive any treatment for acne vulgaris at least six months duration.

You may not qualify if:

• Pregnant and lactating women. 2. History of chronic liver disease . 3. Cardiovascular disorders . 4. Renal disease . 5. Hyperlipidemia . 6. Depression or mental illness. 7. Insulin dependent diabetes 8 Thyroid disease. 9 Osteoporosis or low bone mineral density . 10 Intestinal disorders such as inflammatory bowel disease or ulcerative colitis

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

Qena Hospital

Qina, Egypt

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Isotretinoin

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

• Essra Abass, Lecturer

  Clinical Pathology Department, Faculty of Medicine, South valley University

  PRINCIPAL INVESTIGATOR

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

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 22, 2023
• Study Start: June 1, 2023
• Primary Completion: December 15, 2023
• Study Completion: January 1, 2024
• Last Updated: December 9, 2024

Record last verified: 2023-05

Locations

EG (1)