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

NCT04626817 | Completed

• 1 other identifier: Ankara TRH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Strength

Keywords

Isotretinoin; muscle strength; isokinetic; creatinine phosphokinase

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Isotretinoin receiving group

ACTIVE COMPARATOR

Isotretinoin receiving group for acne vulgaris

Device: Isokinetic device (Biodex System 4)

Local treatment receiving group

PLACEBO COMPARATOR

Local treatment receiving group for acne vulgaris

Device: Isokinetic device (Biodex System 4)

Interventions

Isokinetic device (Biodex System 4) DEVICE

The measurement of muscle strength with isokinetic device

Also known as: serum creatinine phosphokinase level

Isotretinoin receiving group; Local treatment receiving group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• being aged 18-45 years
• receiving isotretinoin treatment for the isotretinoin group
• not having used isotretinoin within the last year for the control group

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cevriye Mülkoğlu: lead

Study Sites (1)

Ankara Training and Research Hospital

Ankara, 06230, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 33743831 DERIVED

Study Officials

• Cevriye Mülkoglu

  Saglik Bakanligi Ankara Egitim ve Arastirma Hastanesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor in Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 13, 2020
• Study Start: September 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

TU (1)