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A comparative study of the effectiveness of oral isotretinoin, the combination of oral isotretinoin and PDL laser and the combination of oral isotretinoin, PDL laser and intradermal tranexamic acid in the prevention of facial scars of inflammatory acne

A comparative study of the effectiveness of oral isotretinoin, the combination of oral isotretinoin and PDL laser and the combination of oral isotretinoin, PDL laser and intradermal tranexamic acid in the prevention of facial scars of inflammatory acne

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241204063936N1
Enrollment
33
Registered
2025-01-11
Start date
2025-01-07
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Inflammatory facial acne. Acne vulgaris

Interventions

Intervention 1: Intervention group: Group 1: Treatment with oral isotretinoin 20 mg every other day. Intervention 2: Intervention group: Group 2: Treatment with a combination of oral isotretinoin 20 m

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 50 Years

Inclusion criteria

Inclusion criteria: Patients with a confirmed diagnosis of inflammatory facial scarring acne The patient has not received any treatment for her illness within the past three months Patient cooperation in carrying out therapeutic interventions and attending all treatment sessions Lack of serious underlying disease

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
The rate of prevention of inflammatory facial acne scars. Timepoint: Assessments are performed 2, 4, and 6 weeks after the start of treatment and 1 month after the end of treatment. Method of measurement: 1. Taking pictures with a Visioface camera to assess the severity of acne scars in terms of width, depth and area. 2. Determining the severity of acne using the Leeds revised acne grading system, which is based on the lesions in the photo and comparing them with the existing criteria, the severity of acne is scored from 1 to 12. 3. Assessing the severity of acne using the global acne grading system, which is based on the location of acne lesions on the face and also based on the type of lesions from comedones to papules, pustules and nodulocystic acne, with a score from 1 to 44, with grades 1 to 18 being mild, 19 to 30 being moderate, 31 to 38 being severe and grades equal to or greater than 39 being very severe. 4. The degree of satisfaction of the doctor and patient with the treatment based on the phsician/patient global assessment score: (completely satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied and completely dissatisfied).

Secondary

MeasureTime frame
Treatment safety, treatment tolerability. Timepoint: Assessments are performed 2, 4, and 6 weeks after the start of treatment and 1 month after the end of treatment. Method of measurement: Evaluation of treatment-related complications including erythema, hyperpigmentation, scaling, and pain using a VesioFace camera.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamidreza Fallahinejad

Iran University of Medical Sciences

rasoolhospital@iums.ac.ir+98 21 6435 1000

Outcome results

None listed

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