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

Acne Vulgaris Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05413200
• Other study ID #: 98
• Status: Completed
• Start date: November 1, 2021
• Est. completion date: June 4, 2022

Study information

• Verified date: June 2022
• Source: Istanbul Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 4, 2022
• Est. primary completion date: April 7, 2022
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris
• Atrophic Acne Scar
• Atrophy
• Isotretinoin

Intervention

Drug:
• Isotretinoin
oral isotretinoin with a standard dose regime for 90 days

Locations

Country	Name	City	State
Turkey	Istanbul Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline atrophic acne scar severity at 90 days	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	Day 0-90
Primary	Change from baseline skin thickness at 90 days	Change from baseline dermal and subcutaneous tissue thickness at 90 days	Day 0-90
Primary	Change from baseline skin elasticity at 90 days	Change from baseline scar and subcutaneous tissue elasticity at 90 days	Day 0-90
Secondary	Change from baseline acne vulgaris severity at 90 days	Change from baseline Global Acne Grading System (minimum score:0, maximum score: 44, severity increases with increasing score) at 90 days	Day 0-90