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Completed

NCT Number: NCT04626817

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

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Training and Research Hospital

Ankara, 06230, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Isokinetic device (Biodex System 4)

Device

The measurement of muscle strength with isokinetic device

Other names: serum creatinine phosphokinase level

Primary outcomes

  1. The hamstring and quadriceps muscle strengths of the non-dominant lower extremity

    Time frame: 6 months

    peak torque values

  2. creatinine phosphokinase

    Time frame: 6 months

    serum creatinine phosphokinase level

Sponsors and collaborators

Lead sponsor

Cevriye Mülkoğlu

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 13, 2020
Registry last updated
Nov 13, 2020

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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