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Black seed vs. Tretinoin in acne vulgaris

Efficacy and safety of Nigella sativa cream (20%) vs. tretinoin cream (0.05%) for acne vulgaris: a randomized right/left double-blind comparative clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20191021045173N1
Enrollment
40
Registered
2020-04-03
Start date
2020-04-08
Completion date
Unknown
Last updated
2022-03-08

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

Conditions

Acne vulgaris. Acne vulgaris

Interventions

20 patients are considered as 40 half faces ,and 2 comparison groups are designed as 20 right and 20 left half faces in order to omit the interindividual differences and compare each participant respo

Sponsors

Islamic Azad University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Age between 18-50 years Clinical diagnosis of mild to moderate facial acne (GAGS score ranging from 1 to 30) made by a dermatologist Discontinuation of any topical or systemic treatment for acne from at least 3 months prior to participation

Exclusion criteria

Exclusion criteria: Pregnancy or lactation, Women with hirsutism, menstrual disorders and hormonal problems, Severe grade of acne, Candidate for isotretinoin treatment, Known allergy to black seed or tretinoin, Subjects who are non-cooperative or unsatisfied with the treatment

Design outcomes

Primary

MeasureTime frame
Acne lesion counts. Timepoint: Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline). Method of measurement: Independent assessment of lesion counts: comedones, papules/pustules.;Reduction of Global Acne Grading System (GAGS) score. Timepoint: Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline). Method of measurement: Rating of acne according to Global Acne Grading System (GAGS) by two dermatologists.;Patients satisfaction. Timepoint: 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline). Method of measurement: Patient subjective satisfaction score ranging from 1 to 100.;Adverse reactions of the study medications. Timepoint: 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline). Method of measurement: Patients reports and clinical assessments by two dermatologists.;Photographic assessment. Timepoint: Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline). Method of measurement: Digital camera.;Visiopore parameters (quantity, size, and value). Timepoint: Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline). Method of measurement: Visiopore device.;Skin hydration. Timepoint: Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline). Method of measurement: Corneometer probe.;Skin erythema. Timepoint: Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline). Method of measurement: mexameter probe.;Skin mel

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mehdi Rajabi

Islamic Azad University

mehdirj@aol.co.uk+98 21 2264 0056

Outcome results

None listed

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