Trials / Completed
CompletedNCT05413200
Investigation of the Effect of Oral Isotretinoin on Skin Thickness and Elasticity in Patients With Atrophic Acne Scar
Investigation of the Effect of Oral Isotretinoin on Clinical Severity, Skin Thickness, and Elasticity in Patients With Moderate to Severe Acne Vulgaris and Atrophic Acne Scar by Shear-Wave Elastography
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 30 (actual)
- Sponsor
- Istanbul Training and Research Hospital · Other Government
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- —
Summary
Acne scar is a common complication of acne vulgaris (AV). Early and effective treatment of AV has a crucial role in managing both acne and acne scarring. Oral isotretinoin (OI) is a widely preferred agent in treating moderate and severe AV worldwide. It has been shown that topical retinoids can also be effective in the treatment of atrophic acne scars. However, there is no study in the literature evaluating the effectiveness of OI protocol on atrophic scars with objective data. With the developing sonoelastography technology in recent years, a quantitative, objective, and reliable examination of the elasticity of the skin and subcutaneous tissue can be provided. In this study, for a detailed and objective evaluation of the effects of OI on atrophic acne scars, we investigate the AV severity, atrophic scar grade, scar size (SS), dermis and subcutaneous tissue thickness (STT), and changes in scar and subcutaneous tissue elastic modulus (EM) in moderate and severe AV patients with atrophic acne scars by clinical observation and SWE. Materials and Methods: It was designed as a single-center, prospective and observational study. Ethics committee approval was obtained. Thirty patients who applied to the Istanbul Training and Research Hospital, Dermatology Department, between November 2021 and January 2022 diagnosed with moderate and severe AV accompanied by atrophic acne scars were included in the study. Demographic characteristics of the patients were recorded. We started the OI with a standard dose regime. On days 0 and 90 of treatment, each patient's AV and scar severity; were evaluated with the global acne grading system (GAGS) and the Goodman and Baron Qualitative Global Scar Rating System (GSRS). On the same days, the dermal thickness (DT), STT, SS, scar, and subcutaneous tissue EM on the right and left cheeks were measured by the same experienced radiologist with SWE. Appropriate statistical methods analyzed the results.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Isotretinoin | oral isotretinoin with a standard dose regime for 90 days |
Timeline
- Start date
- 2021-11-01
- Primary completion
- 2022-04-07
- Completion
- 2022-06-04
- First posted
- 2022-06-09
- Last updated
- 2022-06-09
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT05413200. Inclusion in this directory is not an endorsement.