Acne VulgarisPhase 3NCT06340984
Serum Intercellular Adhesion Molecule -1 in Acne Vulgaris Patients : Effect of Montelukast
A Phase 3 study testing Montelukast 10 Mg Oral Tablet in people with Acne Vulgaris, run by South Valley University.
Trial summary
The aim of this study is to: 1. Evaluation of serum soluble intercellular adhesion molecule-1 (sICAM-1) level in acne vulgaris and compare it to control group 2. Evaluate its role in acne pathogenesis and its correlation with acne vulgaris severity 3. Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Montelukast 10 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Feb 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Intercellular Adhesion Molecule -1 in Acne Vulgaris Patients : Effect of Montelukast Therapy
The aim of this study is to:
- Evaluation of serum soluble intercellular adhesion molecule-1 (sICAM-1) level in acne vulgaris and compare it to control group
- Evaluate its role in acne pathogenesis and its correlation with acne vulgaris severity
- Evaluate the effect of Montelukast on serum (sICAM-1) level in acne vulgaris
Read the detailed description
Acne vulgaris is a common chronic skin disease involving blockage and inflammation of pilosebaceous units
. It is characterized by non-inflammatory, open or closed comedones and by inflammatory lesions include papules, pustules and nodules. Affecting mostly the face, but also the back and chest .
Acne vulgaris may have a psychological impact on any patient, regardless of the severity or the grade of the disease .
Prevalence of self-reported acne was 34.7%. Females significantly reported acne more frequently than males (39.1% vs. 30.3%) Prevalence of clinically confirmed acne was 24.4%, with higher rates among females (28.6%) than males (20.2%).
Its pathogenesis result from increased sebum production (due to increased activity of androgens and insulin growth factor-1), excessive deposition of keratin in pilosebaceous follicles leading to comedo formation, colonization of the follicle by Propionibacterium acnes bacteria, and the local release of pro-inflammatory chemicals in the skin through certain inflammatory mechanisms.
Recently, Inflammation is a key feature in the pathogenesis of acne vulgaris, with various chemokines and cytokines that contribute to fuel a vicious cycle .
Leukotriene B4 (LT-B4) is the most potent leucocyte chemotactic mediator in the pathogenesis of acne . Intercellular adhesion molecule-1 (ICAM-1) is a transmembrane glycoprotein in the immunoglobulin superfamily that increases in response to various inflammation mediator, In addition, genetics is also a key factor in the pathophysiology of acne .
There are various topical therapies for acne vulgaris including topical retinoids, antimicrobials, benzoyl peroxide, salicylic acid, lactic acid, dapsone and niacinamide. Moderate to severe acne is treated with oral antibiotics, especially tetracyclines, and isotretinoin is prescribed for severe acne unresponsive to antibiotics.
Montelukast is an antagonist of LT-B4 receptor . Montelukast has good efficacy, tolerability, and safety in the treatment of acne.
- Conditions
- Acne Vulgaris
- Being tested
- Montelukast 10 Mg Oral Tablet
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montelukast 10 Mg Oral TabletDrug
Also called level of serum intercellular adhesion molecule -1 will be measured by performing an enzyme-linked immune sorbent assay (E LISA)
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: three months following end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study startJun 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alshayma Gamal Fouad, South Valley University
- Investigators
- Hassan Mohammed Ibrahim, Assistant Professor, Study director, South Valley UniversityAbdulrahman Abdul Hamid Alsaied, Professor, Study director, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340984
- Sponsor's protocol ID
- sICAM-1 in acne vulgaris
- Status last verified
- Apr 2024
- First submitted
- 26 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31393195Kellett 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.
PubMed 10233222Tayel 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.
PubMed 33165744Goulden 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.
PubMed 10468803Borgia 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.
PubMed 35328662Charan 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.
PubMed 24049221Roebuck 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.
PubMed 10614768Rokni 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.
PubMed 34648685Grice 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.
PubMed 18588282Zouboulis CC, Bettoli V. Management of severe acne. Br J Dermatol. 2015 Jul;172 Suppl 1:27-36. doi: 10.1111/bjd.13639.
PubMed 25597508Del 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.
PubMed 26029331Alestas 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.
PubMed 16388388
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Intercellular Adhesion Molecule -1 in Acne Vulgaris Patients : Effect of Montelukast Therapy
- ClinicalTrials.gov ID
- NCT06340984
- Acronym / sponsor ID
- sICAM-1 in acne vulgaris
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to:
- Evaluation of serum soluble intercellular adhesion molecule-1 (sICAM-1) level in acne vulgaris and compare it to control group
- Evaluate its role in acne pathogenesis and its correlation with acne vulgaris severity
- Evaluate the effect of Montelukast on serum (sICAM-1) level in acne vulgaris
Detailed description
Acne vulgaris is a common chronic skin disease involving blockage and inflammation of pilosebaceous units
. It is characterized by non-inflammatory, open or closed comedones and by inflammatory lesions include papules, pustules and nodules. Affecting mostly the face, but also the back and chest .
Acne vulgaris may have a psychological impact on any patient, regardless of the severity or the grade of the disease .
Prevalence of self-reported acne was 34.7%. Females significantly reported acne more frequently than males (39.1% vs. 30.3%) Prevalence of clinically confirmed acne was 24.4%, with higher rates among females (28.6%) than males (20.2%).
Its pathogenesis result from increased sebum production (due to increased activity of androgens and insulin growth factor-1), excessive deposition of keratin in pilosebaceous follicles leading to comedo formation, colonization of the follicle by Propionibacterium acnes bacteria, and the local release of pro-inflammatory chemicals in the skin through certain inflammatory mechanisms.
Recently, Inflammation is a key feature in the pathogenesis of acne vulgaris, with various chemokines and cytokines that contribute to fuel a vicious cycle .
Leukotriene B4 (LT-B4) is the most potent leucocyte chemotactic mediator in the pathogenesis of acne . Intercellular adhesion molecule-1 (ICAM-1) is a transmembrane glycoprotein in the immunoglobulin superfamily that increases in response to various inflammation mediator, In addition, genetics is also a key factor in the pathophysiology of acne .
There are various topical therapies for acne vulgaris including topical retinoids, antimicrobials, benzoyl peroxide, salicylic acid, lactic acid, dapsone and niacinamide. Moderate to severe acne is treated with oral antibiotics, especially tetracyclines, and isotretinoin is prescribed for severe acne unresponsive to antibiotics.
Montelukast is an antagonist of LT-B4 receptor . Montelukast has good efficacy, tolerability, and safety in the treatment of acne.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group moderate acne | Active comparator | Drug: Montelukast 10 Mg Oral Tabletpatients 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 |
| group severe acne | Active comparator | Drug: Montelukast 10 Mg Oral Tabletpatients 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 |
| 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) |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- Pregnant and lactating women
- Diabetics
- Hypertensive patients
- acne conglobate patients and acne fulminans patients
- patients with history of polycystic ovaries syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Montelukast 10 Mg Oral TabletAlso: level of serum intercellular adhesion molecule -1 will be measured by performing an enzyme-linked immune sorbent assay (E LISA)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 | Drug | group moderate acne, group severe acne |
Primary outcome
Evaluation of serum soluble intercellular adhesion molecule-1 (sICAM-1) level in acne vulgaris (moderate -severe )
Time frame: baseline and three months at the end of treatment
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
Montelukast in treatment of acne vulgaris patients
Time frame: three months following end of treatment
Evaluate the effect of Montelukast on serum (sICAM-1) level in acne vulgaris (group moderate acne vs group severe acne )and its side effects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Background: PubMed 31393195Hazarika 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.
- Background: PubMed 10233222Kellett 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.
- Background: PubMed 33165744Tayel 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.
- Background: PubMed 10468803Goulden 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.
- Background: PubMed 35328662Borgia 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.
- Background: PubMed 24049221Charan 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.
- Background: PubMed 10614768Roebuck 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.
- Background: PubMed 34648685Rokni 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.
- Background: PubMed 18588282Grice 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.
- Background: PubMed 25597508Zouboulis CC, Bettoli V. Management of severe acne. Br J Dermatol. 2015 Jul;172 Suppl 1:27-36. doi: 10.1111/bjd.13639.
- Background: PubMed 26029331Del 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.
- Background: PubMed 16388388Alestas 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.
- 2\. Mustafa S A G. An Overview About Acne Vulgaris. Journal of Pharmaceutical Negative Results.(2022):4395-4402Link provided by the sponsor.
- 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).Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan Mohammed Ibrahim, Assistant Professor study director
South Valley University
Abdulrahman Abdul Hamid Alsaied, Professor study director
South Valley University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Montelukast 10 Mg Oral Tablet in people with Acne Vulgaris, run by South Valley University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alshaymaa Gamal Fouad, doctor (01065034422, shaymagamal1995@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of serum soluble intercellular adhesion molecule-1 (sICAM-1) level in acne vulgaris (moderate -severe ) (time frame: baseline and three months at the end of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06340984, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.