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

NCT ID: NCT05869188

Last Updated: 2024-12-09

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

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-01-01

Brief Summary

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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.

Detailed Description

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The prevalence of self-reported acne and clinically confirmed acne was 34.69% and 24.39%, respectively. Females reported acne more frequently than males did (39.13% ).The prevalence of clinically confirmed acne was higher among females (28.64%) than males .

Its pathogenesis results from androgen-induced increased sebum production, altered keratinization, inflammation of infundibular epithelium and bacterial colonisation of hair follicles by Propionibacterium acne

There are several treatment modalities for acne vulgaris including topical like topical antibiotics, topical benzoyl peroxide, topical azelaic acid and topical retinoids. Systemic therapy like antibiotics, hormonal therapy and isotretinoin .

Adipokines may have a role in the pathogenesis of acne vulgaris and are associated with acne severity. Irisin, a hormone -like myokine, is one of the adipokines with anti- inflammatory and anti-oxidant effects

There is limited evidence for physical modalities (e.g., laser therapy, light therapy, chemical peels) and complementary therapies (e.g., purified bee venom, low-glycemic-load diet, tea tree oil) .

isotretinoin (13-cis retinoic acid) is the most potent known inhibitor of sebum production. The multiple modes of action for isotretinoin includs suppression of sebaceous gland activity, normalization of the pattern of keratinization within the sebaceous gland follicle, inhibition of inflammation and reduction of growth of Propionibacterium acne .

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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Pateints with Moderate Acne

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.

Group Type ACTIVE_COMPARATOR

Isotretinoin

Intervention Type 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 .

Pateints with Severe Acne

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

Group Type ACTIVE_COMPARATOR

Isotretinoin

Intervention Type 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 .

control

20 Health participants

Group Type ACTIVE_COMPARATOR

Isotretinoin

Intervention Type 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 .

Interventions

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Isotretinoin

* 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 .

Intervention Type DRUG

Other Intervention Names

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irisin

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1 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
Minimum Eligible Age

14 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Nahed Mohammed Abou Elwfa

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Essra Abass, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Clinical Pathology Department, Faculty of Medicine, South valley University

Locations

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Qena Hospital

Qina, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Nahed Abouelwfa

Identifier Type: -

Identifier Source: org_study_id