Effect of Oral Isotretinoin on Muscle Strength in Patients With Acne Vulgaris: A Prospective Controlled Study

Study Overview
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Brief Summary
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BACKGROUND: Musculoskeletal side effects related to isotretinoin are frequently reported. This study aimed to investigate the effect of oral isotretinoin treatment on muscle strength. Our second aim was to evaluate whether there was a correlation between the serum creatine phosphokinase (CPK) level, a specific marker of muscle breakdown, and muscle strength. METHODS: This study included 30 patients who presented to our hospital and were started on oral isotretinoin treatment for acne vulgaris and 30 patients in the control group who were given local treatment. Age, gender, height and weight of the patients were recorded, and the body mass index (BMI) was calculated. The hamstring and quadriceps muscle strengths of the non-dominant side were evaluated in all patients using an isokinetic dynamometer, and the peak torque (PT) values were recorded. In the isotretinoin group, isokinetic measurements were performed again in those that completed six-month drug treatment and compared with the initial PT values.

Detailed Description
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BACKGROUND: Musculoskeletal side effects related to isotretinoin are frequently reported. This study aimed to investigate the effect of oral isotretinoin treatment on muscle strength. Our second aim was to evaluate whether there was a correlation between the serum creatine phosphokinase (CPK) level, a specific marker of muscle breakdown, and muscle strength. METHODS: This study included 30 patients who presented to our hospital and were started on oral isotretinoin treatment for acne vulgaris and 30 patients in the control group who were given local treatment. Age, gender, height and weight of the patients were recorded, and the body mass index (BMI) was calculated. The hamstring and quadriceps muscle strengths of the non-dominant side were evaluated in all patients using an isokinetic dynamometer, and the peak torque (PT) values were recorded. In the isotretinoin group, isokinetic measurements were performed again in those that completed six-month drug treatment and compared with the initial PT values.

Official Title
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Effect of Oral Isotretinoin on Muscle Strength in Patients With Acne Vulgaris: A Prospective Controlled Study

Conditions
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Muscle Strength

Intervention / Treatment
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* Device: Isokinetic device (Biodex System 4)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: being aged 18-45 years receiving isotretinoin treatment for the isotretinoin group not having used isotretinoin within the last year for the control group Exclusion Criteria: chronic kidney or liver disease, uncontrolled hypertension, heart failure, malignancy, thyroid and bone diseases (e.g., hyperparathyroidism and osteomalacia), use of drugs that may affect skeletal metabolism (e.g., corticosteroids, heparin, and anticonvulsants), a history of trauma and/or surgery in the lower extremities. Patients who discontinued or terminated their isotretinoin treatment were not included in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Isotretinoin receiving group<br>Isotretinoin receiving group for acne vulgaris | Device: Isokinetic device (Biodex System 4)<br>* The measurement of muscle strength with isokinetic device<br>* Other names: serum creatinine phosphokinase level;|
| Placebo Comparator: Local treatment receiving group<br>Local treatment receiving group for acne vulgaris | Device: Isokinetic device (Biodex System 4)<br>* The measurement of muscle strength with isokinetic device<br>* Other names: serum creatinine phosphokinase level;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The hamstring and quadriceps muscle strengths of the non-dominant lower extremity | peak torque values | 6 months | 
| creatinine phosphokinase | serum creatinine phosphokinase level | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Isotretinoin, muscle strength, isokinetic, creatinine phosphokinase