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

Sponsor
South Valley University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05869188
Collaborator
(none)
60
1
3
7
8.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

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 .

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect of Systemic Isotretinoin on Serum Irisin Level in Acne Vulgaris Patients
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Dec 15, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Drug: 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 .
Other Names:
  • irisin
  • Active Comparator: 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

    Drug: 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 .
    Other Names:
  • irisin
  • Active Comparator: control

    20 Health participants

    Drug: 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 .
    Other Names:
  • irisin
  • Outcome Measures

    Primary Outcome Measures

    1. Evalaute serum level of irisin in acne patient [From 0 base to 3 Months from starting the treatment Day]

      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)

    Secondary Outcome Measures

    1. Evalaute the effect of treatment with systemic isotretinon [From 0 base to 3 Months from starting the treatment Day]

      Evalaute the effect of treatment with systemic isotretinon on the level of serum irisin .

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Qena Hospital Qinā Egypt

    Sponsors and Collaborators

    • South Valley University

    Investigators

    • Principal Investigator: Essra Abass, Lecturer, Clinical Pathology Department, Faculty of Medicine, South valley University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nahed Mohammed Abou Elwfa, Resident, South Valley University
    ClinicalTrials.gov Identifier:
    NCT05869188
    Other Study ID Numbers:
    • Nahed Abouelwfa
    First Posted:
    May 22, 2023
    Last Update Posted:
    May 24, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 24, 2023