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

November 6, 2020 updated by: Cevriye Mülkoğlu

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06230
        • Ankara Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Isotretinoin receiving group
Isotretinoin receiving group for acne vulgaris
Device: Isokinetic device (Biodex System 4)
The measurement of muscle strength with isokinetic device
Other Names:
  • serum creatinine phosphokinase level
Placebo Comparator: Local treatment receiving group
Local treatment receiving group for acne vulgaris
Device: Isokinetic device (Biodex System 4)
The measurement of muscle strength with isokinetic device
Other Names:
  • serum creatinine phosphokinase level

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cevriye Mülkoğlu

Investigators

  • Principal Investigator: Cevriye Mülkoglu, Saglik Bakanligi Ankara Egitim ve Arastirma Hastanesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

November 3, 2020

First Submitted That Met QC Criteria

November 6, 2020

First Posted (Actual)

November 13, 2020

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 6, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ankara TRH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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