search
Back to results

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

Primary Purpose

Muscle Strength

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Isokinetic device (Biodex System 4)
Sponsored by
Cevriye Mülkoğlu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Muscle Strength focused on measuring Isotretinoin, muscle strength, isokinetic, creatinine phosphokinase

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ankara Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Isotretinoin receiving group

Local treatment receiving group

Arm Description

Isotretinoin receiving group for acne vulgaris

Local treatment receiving group for acne vulgaris

Outcomes

Primary Outcome Measures

The hamstring and quadriceps muscle strengths of the non-dominant lower extremity
peak torque values
creatinine phosphokinase
serum creatinine phosphokinase level

Secondary Outcome Measures

Full Information

First Posted
November 3, 2020
Last Updated
November 6, 2020
Sponsor
Cevriye Mülkoğlu
search

1. Study Identification

Unique Protocol Identification Number
NCT04626817
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cevriye Mülkoğlu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Strength
Keywords
Isotretinoin, muscle strength, isokinetic, creatinine phosphokinase

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isotretinoin receiving group
Arm Type
Active Comparator
Arm Description
Isotretinoin receiving group for acne vulgaris
Arm Title
Local treatment receiving group
Arm Type
Placebo Comparator
Arm Description
Local treatment receiving group for acne vulgaris
Intervention Type
Device
Intervention Name(s)
Isokinetic device (Biodex System 4)
Other Intervention Name(s)
serum creatinine phosphokinase level
Intervention Description
The measurement of muscle strength with isokinetic device
Primary Outcome Measure Information:
Title
The hamstring and quadriceps muscle strengths of the non-dominant lower extremity
Description
peak torque values
Time Frame
6 months
Title
creatinine phosphokinase
Description
serum creatinine phosphokinase level
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cevriye Mülkoglu
Organizational Affiliation
Saglik Bakanligi Ankara Egitim ve Arastirma Hastanesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Training and Research Hospital
City
Ankara
ZIP/Postal Code
06230
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
33743831
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs