Muscle StrengthNCT04626817
Effect of Oral Isotretinoin on Muscle Strength in Patients With Acne Vulgaris: A Prospective Controlled Study
A study testing Isokinetic device (Biodex System 4) in people with Muscle Strength, run by Cevriye Mülkoğlu at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Muscle Strength
- What is being tested?
- Isokinetic device (Biodex System 4)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2018to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- being aged 18-45 years
- receiving isotretinoin treatment for the isotretinoin group
- not having used isotretinoin within the last year for the control group
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Training and Research Hospital
Ankara, 06230
About this study
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.
Read the 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.
- Conditions
- Muscle Strength
- Being tested
- Isokinetic device (Biodex System 4)
- Keywords
- Isotretinoin, muscle strength, isokinetic, creatinine phosphokinase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isokinetic device (Biodex System 4)Device
Also called serum creatinine phosphokinase level
The measurement of muscle strength with isokinetic device
| Study group | Role | What they receive |
|---|---|---|
| Isotretinoin receiving group | Active comparator | Isotretinoin receiving group for acne vulgaris Receives: Device: Isokinetic device (Biodex System 4) |
| Local treatment receiving group | Placebo comparator | Local treatment receiving group for acne vulgaris Receives: Device: Isokinetic device (Biodex System 4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The hamstring and quadriceps muscle strengths of the non-dominant lower extremity
peak torque values
Measured: 6 months
creatinine phosphokinase
serum creatinine phosphokinase level
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Sep 2018
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle StrengthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cevriye Mülkoğlu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cevriye Mülkoğlu, Ankara Training and Research Hospital
- Investigators
- Cevriye Mülkoglu, Principal investigator, Saglik Bakanligi Ankara Egitim ve Arastirma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626817
- Sponsor's protocol ID
- Ankara TRH
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33743831
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Isotretinoin on Muscle Strength in Patients With Acne Vulgaris: A Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT04626817
- Acronym / sponsor ID
- Ankara TRH
- Conditions
- Muscle Strength
- Keywords
- Isotretinoin, muscle strength, isokinetic, creatinine phosphokinase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cevriye MülkoğluUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isotretinoin receiving group | Active comparator | Device: Isokinetic device (Biodex System 4)Isotretinoin receiving group for acne vulgaris |
| Local treatment receiving group | Placebo comparator | Device: Isokinetic device (Biodex System 4)Local treatment receiving group for acne vulgaris |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- being aged 18-45 years
- receiving isotretinoin treatment for the isotretinoin group
- not having used isotretinoin within the last year for the control group
Key exclusion criteria (7 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isokinetic device (Biodex System 4)Also: serum creatinine phosphokinase levelThe measurement of muscle strength with isokinetic device | Device | Isotretinoin receiving group, Local treatment receiving group |
Primary outcome
The hamstring and quadriceps muscle strengths of the non-dominant lower extremity
Time frame: 6 months
peak torque values
creatinine phosphokinase
Time frame: 6 months
serum creatinine phosphokinase level
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Derived from this study: PubMed 33743831Mulkoglu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cevriye Mülkoglu principal investigator
Saglik Bakanligi Ankara Egitim ve Arastirma Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isokinetic device (Biodex System 4) in people with Muscle Strength, run by Cevriye Mülkoğlu at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The hamstring and quadriceps muscle strengths of the non-dominant lower extremity (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04626817, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.