Clinical trial NCT04626817: Effect of Oral Isotretinoin on Muscle Strength in Patients With Acne Vulgaris: A Prospective Controlled Study
Official title: Effect of Oral Isotretinoin on Muscle Strength in Patients With Acne Vulgaris: A Prospective Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Strength
Keywords: Isotretinoin
muscle strength
isokinetic
creatinine phosphokinase
Lead sponsor: Ankara Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The hamstring and quadriceps muscle strengths of the non-dominant lower extremity
timeFrame: 6 months
measure: creatinine phosphokinase
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Training and Research Hospital
Study officials:
affiliation: Saglik Bakanligi Ankara Egitim ve Arastirma Hastanesi
name: Cevriye Mülkoglu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mulkoglu C, Karaosmanoglu N. Effect of oral isotretinoin on muscle strength in patients with acne vulgaris: a prospective controlled study. BMC Pharmacol Toxicol. 2021 Mar 20;22(1):17. doi: 10.1186/s40360-021-00483-0.