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

Sponsor
Cevriye Mülkoğlu (Other)
Overall Status
Completed
CT.gov ID
NCT04626817
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
13
Actual Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Isokinetic device (Biodex System 4)
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Effect of Oral Isotretinoin on Muscle Strength in Patients With Acne Vulgaris: A Prospective Controlled Study
Actual Study Start Date :
Sep 1, 2018
Actual Primary Completion Date :
Oct 1, 2019
Actual Study Completion Date :
Oct 1, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The hamstring and quadriceps muscle strengths of the non-dominant lower extremity [6 months]

      peak torque values

    2. creatinine phosphokinase [6 months]

      serum creatinine phosphokinase level

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ankara Training and Research Hospital Ankara Turkey 06230

    Sponsors and Collaborators

    • Cevriye Mülkoğlu

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cevriye Mülkoğlu, Medical Doctor in Department of Physical Medicine and Rehabilitation, Ankara Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT04626817
    Other Study ID Numbers:
    • Ankara TRH
    First Posted:
    Nov 13, 2020
    Last Update Posted:
    Nov 13, 2020
    Last Verified:
    Nov 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Cevriye Mülkoğlu, Medical Doctor in Department of Physical Medicine and Rehabilitation, Ankara Training and Research Hospital
    Isotretinoin
    muscle strength
    isokinetic
    creatinine phosphokinase
    Additional relevant MeSH terms:
    Acne Vulgaris

    Study Results

    No Results Posted as of Nov 13, 2020