Serum Intercellular Adhesion Molecule -1 in Acne Vulgaris Patients : Effect of Montelukast

NCT06340984 | Not Yet Recruiting Phase 3

• 1 other identifier: sICAM-1 in acne vulgaris
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to:

1. 1.Evaluation of serum soluble intercellular adhesion molecule-1 (sICAM-1) level in acne vulgaris and compare it to control group
2. 2.Evaluate its role in acne pathogenesis and its correlation with acne vulgaris severity
3. 3.Evaluate the effect of Montelukast on serum (sICAM-1) level in acne vulgaris

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• Evaluation of serum soluble intercellular adhesion molecule-1 (sICAM-1) level in acne vulgaris (moderate -severe )

  evaluation of serum soluble intercellular adhesion molecule-1 (sICAM-1) level by ELISA in acne vulgaris(moderate -severe) and compare it to control group, correlation with acne vulgaris severity and its role in pathogenesis

  baseline and three months at the end of treatment

• Montelukast in treatment of acne vulgaris patients

  Evaluate the effect of Montelukast on serum (sICAM-1) level in acne vulgaris (group moderate acne vs group severe acne )and its side effects

  three months following end of treatment

Study Arms (3)

group moderate acne

ACTIVE COMPARATOR

patients with moderate acne vulgaris who will receive Montelukast therapy dose: 10mg/day, duration of therapy: three months, serum level of intercellular adhesion molecule -1 will be measured by performing an enzyme-linked immune sorbent assay (E LISA) before and after treatment

Drug: Montelukast 10 Mg Oral Tablet

group severe acne

ACTIVE COMPARATOR

patients with severe acne vulgaris who will receive Montelukast therapy dose: 10mg/day, duration of therapy: three months, serum level of intercellular adhesion molecule -1 will be measured by performing an enzyme-linked immune sorbent assay (E LISA) before and after treatment

Drug: Montelukast 10 Mg Oral Tablet

control group

NO INTERVENTION

Healthy patients with Age and sex matching ,No history of acne, serum level of intercellular adhesion molecule -1 will be measured by performing an enzyme-linked immune sorbent assay (E LISA)

Interventions

Montelukast 10 Mg Oral Tablet DRUG

group modrate and severe acne will receive Montelukast therapy , dose: 10mg/day, duration of therapy: three months., Quantitively assay of level of serum intercellular adhesion molecule -1 will be measured by performing an enzyme-linked immune sorbent assay (E LISA) in group moderate acne vs group severe acne pre Montelukast treatment and after three months of treatment vs control group

Also known as: level of serum intercellular adhesion molecule -1 will be measured by performing an enzyme-linked immune sorbent assay (E LISA)

group moderate acne; group severe acne

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy persons of both sexes with moderate and severe acne vulgaris.
• Patients age between 15-35 years
• Patients with acne vulgaris not receiving any topical or systemic treatments for acne at least 2 weeks and 2 month before the study ,respectively

You may not qualify if:

• Pregnant and lactating women
• Diabetics
• Hypertensive patients
• acne conglobate patients and acne fulminans patients
• patients with history of polycystic ovaries syndrome
• Patients with history of thyroid dysfunction
• Patients with history of chronic inflammatory or immune-mediated diseases as Crohn's disease, vascular dementia, systemic sclerosis, systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis and SAPHO syndrome.
• Any history of hypersensitivity reaction to the studied drug

Sponsors & Collaborators

• South Valley University: lead

Related Publications (12)

• Hazarika N. Acne vulgaris: new evidence in pathogenesis and future modalities of treatment. J Dermatolog Treat. 2021 May;32(3):277-285. doi: 10.1080/09546634.2019.1654075. Epub 2019 Aug 29.

  PMID: 31393195 BACKGROUND

• Kellett SC, Gawkrodger DJ. The psychological and emotional impact of acne and the effect of treatment with isotretinoin. Br J Dermatol. 1999 Feb;140(2):273-82. doi: 10.1046/j.1365-2133.1999.02662.x.

  PMID: 10233222 BACKGROUND

• Tayel K, Attia M, Agamia N, Fadl N. Acne vulgaris: prevalence, severity, and impact on quality of life and self-esteem among Egyptian adolescents. J Egypt Public Health Assoc. 2020 Nov 5;95(1):30. doi: 10.1186/s42506-020-00056-9.

  PMID: 33165744 BACKGROUND

• Goulden V, McGeown CH, Cunliffe WJ. The familial risk of adult acne: a comparison between first-degree relatives of affected and unaffected individuals. Br J Dermatol. 1999 Aug;141(2):297-300. doi: 10.1046/j.1365-2133.1999.02979.x.

  PMID: 10468803 BACKGROUND

• Borgia F, Peterle L, Custurone P, Vaccaro M, Pioggia G, Gangemi S. MicroRNA Cross-Involvement in Acne Vulgaris and Hidradenitis Suppurativa: A Literature Review. Int J Mol Sci. 2022 Mar 17;23(6):3241. doi: 10.3390/ijms23063241.

  PMID: 35328662 BACKGROUND

• Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232.

  PMID: 24049221 BACKGROUND

• Roebuck KA, Finnegan A. Regulation of intercellular adhesion molecule-1 (CD54) gene expression. J Leukoc Biol. 1999 Dec;66(6):876-88. doi: 10.1002/jlb.66.6.876.

  PMID: 10614768 BACKGROUND

• Rokni GR, Mohammadnezhad F, Saeedi M, Shadi S, Sharma A, Sandhu S, Gupta A, Goldust M. Efficacy, tolerability, and safety of montelukast versus finasteride for the treatment of moderate acne in women: A prospective, randomized, single-blinded, active-controlled trial. J Cosmet Dermatol. 2021 Nov;20(11):3580-3585. doi: 10.1111/jocd.14462. Epub 2021 Oct 14.

  PMID: 34648685 BACKGROUND

• Grice CA, Tays KL, Savall BM, Wei J, Butler CR, Axe FU, Bembenek SD, Fourie AM, Dunford PJ, Lundeen K, Coles F, Xue X, Riley JP, Williams KN, Karlsson L, Edwards JP. Identification of a potent, selective, and orally active leukotriene a4 hydrolase inhibitor with anti-inflammatory activity. J Med Chem. 2008 Jul 24;51(14):4150-69. doi: 10.1021/jm701575k. Epub 2008 Jun 28.

  PMID: 18588282 BACKGROUND

• Zouboulis CC, Bettoli V. Management of severe acne. Br J Dermatol. 2015 Jul;172 Suppl 1:27-36. doi: 10.1111/bjd.13639.

  PMID: 25597508 BACKGROUND

• Del Rosso JQ. Oral Doxycycline in the Management of Acne Vulgaris: Current Perspectives on Clinical Use and Recent Findings with a New Double-scored Small Tablet Formulation. J Clin Aesthet Dermatol. 2015 May;8(5):19-26.

  PMID: 26029331 BACKGROUND

• Alestas T, Ganceviciene R, Fimmel S, Muller-Decker K, Zouboulis CC. Enzymes involved in the biosynthesis of leukotriene B4 and prostaglandin E2 are active in sebaceous glands. J Mol Med (Berl). 2006 Jan;84(1):75-87. doi: 10.1007/s00109-005-0715-8. Epub 2005 Dec 31.

  PMID: 16388388 BACKGROUND

Related Links

• 2\. Mustafa S A G. An Overview About Acne Vulgaris. Journal of Pharmaceutical Negative Results.(2022):4395-4402
• 14\. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER).Guidance for industry. Acne vulgaris: developing drugs for treatment.(2005).

MeSH Terms

Conditions

Acne Vulgaris

Interventions

montelukast; Tablets

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Hassan Mohammed Ibrahim, Assistant Professor

  South Valley University

  STUDY DIRECTOR

• Abdulrahman Abdul Hamid Alsaied, Professor

  South Valley University

  STUDY DIRECTOR

Central Study Contacts

Alshaymaa Gamal Fouad, doctor

CONTACT

01065034422; shaymagamal1995@gmail.com

soher Abdelhamid Ali, Lecturer

CONTACT

01066877343; soher.abdel-hamid@med.svu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 2, 2024
• Study Start: June 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: February 1, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share