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Montelukast effect in acne treatment

A Controlled clinical trial to compare the effet of Montelukast and placeboo on disease symptoms and process among 45-15 year old patients with mild to moderate acne

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017020632402N1
Enrollment
40
Registered
2017-06-19
Start date
2016-02-19
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne. Acne vulgaris

Interventions

Intervention 1: Intervention group: Treatment with Montelukast 5 mg chewable tablet, once a day plus tertinoin 0.25% +and clindamycin topical cream (acnomis) applied to the whole face once a day for 3
Treatment - Drugs
Intervention group: Treatment with Montelukast 5 mg chewable tablet, once a day plus tertinoin 0.25% +and clindamycin topical cream (acnomis) applied to the whole face once a day for 3 months.
Control group: Treatment with placebo chewable tablet once a day plus tertinoin 0.25% +and clindamycin topical cream (acnomis) applied to the whole face once a day for 3 months.

Sponsors

Vice Chancellor for research, Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients with acne; being at the age of 15-45 years old; using antibiotic and other acne treatments for less than 3 months. Exclusion criteria: age under 14 year-old and older than 45 year-old; indication for systemic retinoid treatment; nodulocystic acne (with scar formation possibility); antibiotic treatment for more than 3 months; Hormonal related acne(polycystic ovarian disease)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Acne severity. Timepoint: Before treatment, 1 month and 3 months after treatment. Method of measurement: Acne global severity scale questionnaire.

Secondary

MeasureTime frame
Drug Side effects. Timepoint: 1 month and 3 months after the begining of treatment. Method of measurement: Asking patients.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSamane Moghanlou

Razi skin hospital

Samane.moghanlou@gmail.com+98 912 338 3537

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026