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

NCT ID: NCT04626817

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-10-01

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.

Conditions

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Muscle Strength

Keywords

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Isotretinoin muscle strength isokinetic creatinine phosphokinase

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Isotretinoin receiving group

Isotretinoin receiving group for acne vulgaris

Group Type ACTIVE_COMPARATOR

Isokinetic device (Biodex System 4)

Intervention Type DEVICE

The measurement of muscle strength with isokinetic device

Local treatment receiving group

Local treatment receiving group for acne vulgaris

Group Type PLACEBO_COMPARATOR

Isokinetic device (Biodex System 4)

Intervention Type DEVICE

The measurement of muscle strength with isokinetic device

Interventions

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Isokinetic device (Biodex System 4)

The measurement of muscle strength with isokinetic device

Intervention Type DEVICE

Other Intervention Names

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serum creatinine phosphokinase level

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cevriye Mülkoğlu

OTHER

Sponsor Role lead

Responsible Party

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Cevriye Mülkoğlu

Medical Doctor in Department of Physical Medicine and Rehabilitation

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Cevriye Mülkoglu

Role: PRINCIPAL_INVESTIGATOR

Saglik Bakanligi Ankara Egitim ve Arastirma Hastanesi

Locations

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Ankara Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 33743831 (View on PubMed)

Other Identifiers

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Ankara TRH

Identifier Type: -

Identifier Source: org_study_id