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NCT Number: NCT05413200

Investigation of the Effect of Oral Isotretinoin on Skin Thickness and Elasticity in Patients With Atrophic Acne Scar

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Atrophic Acne Scar Isotretinoin Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Training and Research Hospital

Istanbul, 34098, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being over 18 years old
  • Being under 65 years old
  • Moderate to severe acne vulgaris with atrophic acne scars
  • Absence of keloidal or hypertrophic scars
  • Planning the use of oral isotretinoin in the treatment
  • No additional disease
  • Not smoking
  • Consent to participate in the study and treatment

Exclusion criteria

  • Using isotretinoin in the last 1 year
  • Using topical or systemic medication in addition to oral isotretinoin for the treatment of acne vulgaris
  • Having a keloidal or hypertrophic scar
  • Being in pregnancy and lactation period
  • To plan a pregnancy or are unable to adapt to contraception
  • Known chronic diseases; skin cancer and other cancers, uncontrolled such as diabetes, hepatic failure/dysfunction, renal failure/dysfunction, neuromuscular diseases, autoimmune connective tissue diseases, hematological diseases, malabsorption diseases, inflammatory bowel diseases, pseudotumor cerebri, psychiatric diseases, and alcoholism.
  • Severe hypercholesterolemia (>250 mg/dL), hypertriglyceridemia (> 500 mg/dL)
  • Elevated liver function tests (ALT, AST, GGT, ALP) exceeding 3 times the upper limit
  • Creatine kinase elevation exceeding 5 times the upper limit
  • Using regular medication for another known disease
  • To smoke
  • A dermatological pathology other than facial acne vulgaris. (seborrheic dermatitis, rosacea, perioral dermatitis, herpes infection, impetigo, cutaneous lupus erythematosus, solar keratosis)
  • Using Vitamin A
  • Those who have or will receive a blood transfusion (during treatment or within 1 month after treatment)
  • Hypersensitivity to the drug's preservatives
  • Unrealistic expectations from treatment

Treatment and study plan

isotretinoin

Drug

oral isotretinoin with a standard dose regime for 90 days

Primary outcomes

  1. Change from baseline atrophic acne scar severity at 90 days

    Time frame: Day 0-90

    Change from baseline Goodman and Baron Qualitative Global Scar Rating System (first grade: grade 1, last grade: grade 4. Scar severity increases with increasing grade) at 90 days

  2. Change from baseline skin thickness at 90 days

    Time frame: Day 0-90

    Change from baseline dermal and subcutaneous tissue thickness at 90 days

  3. Change from baseline skin elasticity at 90 days

    Time frame: Day 0-90

    Change from baseline scar and subcutaneous tissue elasticity at 90 days

Secondary outcomes

  1. Change from baseline acne vulgaris severity at 90 days

    Time frame: Day 0-90

    Change from baseline Global Acne Grading System (minimum score:0, maximum score: 44, severity increases with increasing score) at 90 days

Sponsors and collaborators

Lead sponsor

Istanbul Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 9, 2022
Registry last updated
Jun 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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