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

Completed

• Conditions: Isotretinoin; Acne Vulgaris; Atrophic Acne Scar
• Interventions: Drug: Isotretinoin

• Registration Number: NCT05413200
• Lead Sponsor: Istanbul Training and Research Hospital

Brief 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. Howev...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-11-01
• Primary Completion: 2022-04-07
• Status Verified: 2022-06
• Study Completion: 2022-06-04
• Study First Submitted: 2022-06-04
• Study First Submitted QC: 2022-06-07
• Last Update Submitted: 2022-06-07
• Study First Posted: 2022-06-09
• Last Update Posted: 2022-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Isotretinoin	Patients diagnosed with moderate and severe AV accompanied by atrophic acne scars

Primary Outcome Measures

Name	Time	Method
Change from baseline skin elasticity at 90 days	Day 0-90	Change from baseline scar and subcutaneous tissue elasticity at 90 days
Change from baseline skin thickness at 90 days	Day 0-90	Change from baseline dermal and subcutaneous tissue thickness at 90 days
Change from baseline atrophic acne scar severity at 90 days	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

Secondary Outcome Measures

Name	Time	Method
Change from baseline acne vulgaris severity at 90 days	Day 0-90	Change from baseline Global Acne Grading System (minimum score:0, maximum score: 44, severity increases with increasing score) at 90 days

Trial Locations

Locations (1)

Istanbul Training and Research Hospital; 🇹🇷 Istanbul, Turkey