Status:
COMPLETED
Investigation of the Effect of Oral Isotretinoin on Skin Thickness and Elasticity in Patients With Atrophic Acne Scar
Lead Sponsor:
Istanbul Training and Research Hospital
Conditions:
Acne Vulgaris
Isotretinoin
Eligibility:
All Genders
18-65 years
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 4 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05413200
Start Date
November 1 2021
End Date
June 4 2022
Last Update
June 9 2022
Active Locations (1)
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1
Istanbul Training and Research Hospital
Istanbul, Turkey (Türkiye), 34098