IsotretinoinNCT07196787
Exercise Therapy for Isotretinoin Users
A study testing Exercise in people with Isotretinoin and Isotretinoin Adverse Reaction, run by Uşak University at 1 site in Turkey (Türkiye).
Trial summary
Isotretinoin (13-cis retinoic acid) is a retinoic acid that is a derivative of vitamin A. Isotretinoin has been used effectively alone in acne treatment for 35 years. However, it has many side effects. Among the musculoskeletal side effects of this treatment, acute sacroileitis is a common condition. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Isotretinoin, Isotretinoin Adverse Reaction
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2025to 26 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The participant is between the ages of 18-35,
- Not having a regular exercise habit,
- Starting Isotretinoin treatment for the first time.
Who cannot join
- Presence of any diagnosed rheumatologic disease,
- The presence of any diagnosed neurological disease,
- Having any diagnosed psychiatric illness,
- Having a physical disability that prevents them from exercising for any reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Usak University
Uşak, 64200
Ali Y Karahan, MD, +905386921934, ali.karahan@usak.edu.tr
About this study
Official title: Prophylactic Exercise Therapy for Musculoskeletal Side Effects in Isotretinoin Users: A Controlled Study
Isotretinoin (13-cis retinoic acid) is a retinoic acid that is a derivative of vitamin A. Isotretinoin has been used effectively alone in acne treatment for 35 years. However, it has many side effects. Among the musculoskeletal side effects of this treatment, acute sacroileitis is a common condition. In this clinical picture, recovery may last for a few months after discontinuation of isotretinoin treatment. However, it may become permanent in some cases. According to our current knowledge, there is no study in the literature that prescribes exercise therapy for this patient group. This study, planned to investigate the effects of stretching and sacroiliac mobilization exercises on musculoskeletal pain and quality of life, which are among the side effects of isotretinoin treatment.
Read the detailed description
Isotretinoin (13-cis retinoic acid) is a vitamin A derivative of retinoic acid. It was approved by the FDA in 1982 for the treatment of severe, refractory nodulocystic acne. Isotretinoin has been used effectively alone in the treatment of acne for 35 years. Isotretinoin is used in a daily dose range of 0.5-1 mg/kg/day. Starting treatment with high doses increases the risk of acute exacerbation, inflammation and scarring and is not recommended. The side effects of this treatment are often dose-dependent and the most common side effects are related to the skin and mucous membranes. Hypervitaminosis A-related side effects affecting the skin, eye, neurologic, hepatic and skeletal-muscular system are available. On the skin; dryness, cheilitis, dryness in the eyes, epistaxis, itching, dryness in the eyes may be observed. Ocular findings include xerophthalmia, conjunctivitis, night blindness, keratitis and optic neuritis. Pseudotumor cerebri, a rare side effect, is characterized by severe headache, nausea and visual changes. As a result, side effects such as forgetfulness, headache, decreased concentration, menstrual irregularity, increased blood lipid and transaminase levels, myalgia, arthralgia and low back pain may be observed during isotretinoin use . Isotretinoin-associated bilateral or unilateral sacroiliitis is among other reported side effects. Sacroiliitis is usually seen as acute sacroiliitis days or weeks after the start of isotretinoin treatment. Recent literature suggests that the reduction of pro-inflammatory cytokines (e.g. TNF-α, IL-1β, IL-6) and the release of anti-inflammatory myokines (e.g. IL-6, IL-10) are the key mechanisms of exercise in inflammatory rheumatic diseases. In addition, the function of regulatory T-cells is enhanced by exercise, which also reduces oxidative stress and improves the function of these cells. A review of the benefits of exercise in PsA was carried out, with findings including reduced disease activity, improved physical function and decreased inflammation. Moreover, discourse is had on the psychological advantages of physical exertion, including a reduction in symptoms of depression and anxiety. The impact of exercise on AS was evaluated, with improvements in spinal mobility, pain and inflammation being emphasised. They also discuss the role of exercise. They discuss how exercise can reduce oxidative stress. They also discuss how exercise can improve cardiovascular health. They focus on this in relation to AS patients. So, the hypothesis of this study was predicated on the theory that regular exercise reduces disease burden by improving joint mobility, muscle strength and overall physical function, in addition to its salutary anti-inflammatory effects. The H1 hypothesis of this study was that regular exercise programmes have a favourable impact on the adverse musculoskeletal effects of isotretinoin treatment.
Material-Method:
In this study, it was planned to investigate the effects of stretching and sacroiliac mobilization exercises on musculoskeletal pain and sacroileitis, which are side effects of the drug, on musculoskeletal pain and quality of life in patients started on isotretinoin treatment. Between August 2025 and January 2026, patients who applied to the dermatology outpatient clinic and planned to start isotretinoin will be informed about the study, one group will be taught a sacroiliac stretching and mobilization exercise program and will be asked to perform these exercises 10 times in 2 sets every day. The other group will consist of patients who do not exercise and take medication. Within the scope of this prospectively planned study, it is planned to evaluate the patients by collecting data in 4 stages. The first stage will be collected before the start of isotretinoin treatment, the second stage in the 1st month of treatment, the third stage in the 3rd month of treatment and the last stage in the 6th month of treatment by evaluating pain measurement and quality of life. Musculoskeletal pain measurements, quality of life, and conditions occurring during follow-up will be evaluated and compared between the exercising group and the non-exercising group.
Pain measurement; The pain sensitivity of the subjects to pressure will be evaluated with a pain meter device called algometer. Algometer Commender Jtech Medical 801-478 USA brand digital algometer will be used in the evaluation. This device is already in current use and belongs to the researchers themselves. The algometer will be used to measure the trapezius muscle trunk, latissimus dorsi muscle trunk and sacroiliac joints bilaterally 3 times each. Before the measurement, the areas will be marked and the algometer will be placed perpendicular to these points and the subjects will be asked to report the first sensation of pain. The pain threshold will be recorded in pounds (1kg=2.2 pounds) by reading the value on the indicator.
Quality of Life measurement; World Health Organization Quality of Life (WHOQOL-SHORT FORM) is a statement-based measure developed to assess perception, personal goals, standards and concerns within one's own culture and values. The WHOQOL-SHORT FORM measures the following domains: physical health, psychological health, social relationships and environment. High scores indicate high quality of life, while low scores indicate low quality of life. Turkish validity and reliability has been realized (4).
Hypothesis(es): Regular exercises will have a positive effect on pain and quality of daily life levels in patients started on isotretinoin treatment.
- Conditions
- Isotretinoin, Isotretinoin Adverse Reaction
- Being tested
- Exercise
- Keywords
- exercise, pain, prophylaxis, side effects
- Medical subject headings
- Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
The 18-Week Program Structure This program is divided into three 6-week phases. Each week consists of 5 sessions, mixing different focuses to ensure balanced development.
Day 1: Foundational Strength \& Stability
Day 2: Low-Impact Cardio \& Active Recovery
Day 3: Core Focus \& Hip Stability
Day 4: Low-Impact Cardio \& Mobility
Day 5: Full Body Integration \& Strength
| Study group | Role | What they receive |
|---|---|---|
| Sacroiliac (SI) joint exercise group | Experimental | This 18-week, 5-day-a-week program is a comprehensive plan designed to build stability, strength, and mobility progressively while being mindful of the sensitivity of the SI joint.
This program is divided into three 6-week phases. Each week consists of 5 sessions, mixing different focuses to ensure balanced development.
Day 1: Foundational Strength \& Stability
Day 2: Low-Impact Cardio \& Active Recovery
Day 3: Core Focus \& Hip Stability
Day 4: Low-Impact Cardio \& Mobility
Day 5: Full Body Integration \& Strength Receives: Other: Exercise |
| Control group | No intervention | Control group: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Algometer Testing
Device: Jtech Medical 801/478 USA™ digital pressure algometer. Data collected and processed from the human algometer will generate a specific nociceptive response to neurostimulation in the somatosensory cortex.
The algometer head was applied at a 90° angle to trigger points at selected locations, with pressure increased at a speed of approximately 100 g/s. One measurement was taken at the first sensation of pain, after which the process stopped.
Measured: Baseline / first month / third month / sixth month
Short Form 36
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. Pricing depends on the number of scores that the researcher needs to calculate.
Measured: Baseline / first month / third month / sixth month
Secondary outcomes (1)
VAS (visual analogue scale)
The VAS is a unidimensional measure of pain intensity that is used to record patients' pain progression or to compare the severity of pain between patients with similar conditions. Numerical rating scales will be used. The score is determined by measuring the distance (in millimetres) on the 10-centimetre line between the 'no pain' anchor and the patient's mark. This provides a range of scores from 0 to 100. A higher score indicates greater pain intensity.
Measured: Baseline / first month / third month / sixth month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start30 Sep 2025
- Primary completion6 Feb 2026 (estimated)
- Study completion26 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IsotretinoinStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controlled study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asli keles onal, Uşak University
- Investigators
- Ali Y Karahan, MD, Study director, Uşak University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196787
- Sponsor's protocol ID
- Asli1
- Status last verified
- Nov 2025
- First submitted
- 19 Sep 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Research data supporting this publication are available upon request from the authors. The datasets generated and/or analyzed during the current study are available from the corresponding author; Ali Yavuz Karahan email: ali.karahan@usak.edu.tr / mobile: +905386921934.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Exercise Therapy for Musculoskeletal Side Effects in Isotretinoin Users: A Controlled Study
- ClinicalTrials.gov ID
- NCT07196787
- Acronym / sponsor ID
- Asli1
- Conditions
- Isotretinoin, Isotretinoin Adverse Reaction
- Keywords
- exercise, pain, prophylaxis, side effects
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 6 Feb 2026 (estimated)
- Study completion
- 26 Mar 2026 (estimated)
- First posted
- 29 Sep 2025 (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.
Isotretinoin (13-cis retinoic acid) is a retinoic acid that is a derivative of vitamin A. Isotretinoin has been used effectively alone in acne treatment for 35 years. However, it has many side effects. Among the musculoskeletal side effects of this treatment, acute sacroileitis is a common condition. In this clinical picture, recovery may last for a few months after discontinuation of isotretinoin treatment. However, it may become permanent in some cases. According to our current knowledge, there is no study in the literature that prescribes exercise therapy for this patient group. This study, planned to investigate the effects of stretching and sacroiliac mobilization exercises on musculoskeletal pain and quality of life, which are among the side effects of isotretinoin treatment.
Detailed description
Isotretinoin (13-cis retinoic acid) is a vitamin A derivative of retinoic acid. It was approved by the FDA in 1982 for the treatment of severe, refractory nodulocystic acne. Isotretinoin has been used effectively alone in the treatment of acne for 35 years. Isotretinoin is used in a daily dose range of 0.5-1 mg/kg/day. Starting treatment with high doses increases the risk of acute exacerbation, inflammation and scarring and is not recommended. The side effects of this treatment are often dose-dependent and the most common side effects are related to the skin and mucous membranes. Hypervitaminosis A-related side effects affecting the skin, eye, neurologic, hepatic and skeletal-muscular system are available. On the skin; dryness, cheilitis, dryness in the eyes, epistaxis, itching, dryness in the eyes may be observed. Ocular findings include xerophthalmia, conjunctivitis, night blindness, keratitis and optic neuritis. Pseudotumor cerebri, a rare side effect, is characterized by severe headache, nausea and visual changes. As a result, side effects such as forgetfulness, headache, decreased concentration, menstrual irregularity, increased blood lipid and transaminase levels, myalgia, arthralgia and low back pain may be observed during isotretinoin use . Isotretinoin-associated bilateral or unilateral sacroiliitis is among other reported side effects. Sacroiliitis is usually seen as acute sacroiliitis days or weeks after the start of isotretinoin treatment. Recent literature suggests that the reduction of pro-inflammatory cytokines (e.g. TNF-α, IL-1β, IL-6) and the release of anti-inflammatory myokines (e.g. IL-6, IL-10) are the key mechanisms of exercise in inflammatory rheumatic diseases. In addition, the function of regulatory T-cells is enhanced by exercise, which also reduces oxidative stress and improves the function of these cells. A review of the benefits of exercise in PsA was carried out, with findings including reduced disease activity, improved physical function and decreased inflammation. Moreover, discourse is had on the psychological advantages of physical exertion, including a reduction in symptoms of depression and anxiety. The impact of exercise on AS was evaluated, with improvements in spinal mobility, pain and inflammation being emphasised. They also discuss the role of exercise. They discuss how exercise can reduce oxidative stress. They also discuss how exercise can improve cardiovascular health. They focus on this in relation to AS patients. So, the hypothesis of this study was predicated on the theory that regular exercise reduces disease burden by improving joint mobility, muscle strength and overall physical function, in addition to its salutary anti-inflammatory effects. The H1 hypothesis of this study was that regular exercise programmes have a favourable impact on the adverse musculoskeletal effects of isotretinoin treatment.
Material-Method:
In this study, it was planned to investigate the effects of stretching and sacroiliac mobilization exercises on musculoskeletal pain and sacroileitis, which are side effects of the drug, on musculoskeletal pain and quality of life in patients started on isotretinoin treatment. Between August 2025 and January 2026, patients who applied to the dermatology outpatient clinic and planned to start isotretinoin will be informed about the study, one group will be taught a sacroiliac stretching and mobilization exercise program and will be asked to perform these exercises 10 times in 2 sets every day. The other group will consist of patients who do not exercise and take medication. Within the scope of this prospectively planned study, it is planned to evaluate the patients by collecting data in 4 stages. The first stage will be collected before the start of isotretinoin treatment, the second stage in the 1st month of treatment, the third stage in the 3rd month of treatment and the last stage in the 6th month of treatment by evaluating pain measurement and quality of life. Musculoskeletal pain measurements, quality of life, and conditions occurring during follow-up will be evaluated and compared between the exercising group and the non-exercising group.
Pain measurement; The pain sensitivity of the subjects to pressure will be evaluated with a pain meter device called algometer. Algometer Commender Jtech Medical 801-478 USA brand digital algometer will be used in the evaluation. This device is already in current use and belongs to the researchers themselves. The algometer will be used to measure the trapezius muscle trunk, latissimus dorsi muscle trunk and sacroiliac joints bilaterally 3 times each. Before the measurement, the areas will be marked and the algometer will be placed perpendicular to these points and the subjects will be asked to report the first sensation of pain. The pain threshold will be recorded in pounds (1kg=2.2 pounds) by reading the value on the indicator.
Quality of Life measurement; World Health Organization Quality of Life (WHOQOL-SHORT FORM) is a statement-based measure developed to assess perception, personal goals, standards and concerns within one's own culture and values. The WHOQOL-SHORT FORM measures the following domains: physical health, psychological health, social relationships and environment. High scores indicate high quality of life, while low scores indicate low quality of life. Turkish validity and reliability has been realized (4).
Hypothesis(es): Regular exercises will have a positive effect on pain and quality of daily life levels in patients started on isotretinoin treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Controlled study
| Arm | Type | Receives |
|---|---|---|
| Sacroiliac (SI) joint exercise group | Experimental | Other: ExerciseThis 18-week, 5-day-a-week program is a comprehensive plan designed to build stability, strength, and mobility progressively while being mindful of the sensitivity of the SI joint. This program is divided into three 6-week phases. Each week consists of 5 sessions, mixing different focuses to ensure balanced development. Day 1: Foundational Strength \& Stability Day 2: Low-Impact Cardio \& Active Recovery Day 3: Core Focus \& Hip Stability Day 4: Low-Impact Cardio \& Mobility Day 5: Full Body Integration \& Strength |
| Control group | No intervention | –Control group: No intervention |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The participant is between the ages of 18-35,
- Not having a regular exercise habit,
- Starting Isotretinoin treatment for the first time.
Key exclusion criteria (4 listed)
- Presence of any diagnosed rheumatologic disease,
- The presence of any diagnosed neurological disease,
- Having any diagnosed psychiatric illness,
- Having a physical disability that prevents them from exercising for any reason.
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 |
|---|---|---|
| ExerciseThe 18-Week Program Structure This program is divided into three 6-week phases. Each week consists of 5 sessions, mixing different focuses to ensure balanced development. Day 1: Foundational Strength \& Stability Day 2: Low-Impact Cardio \& Active Recovery Day 3: Core Focus \& Hip Stability Day 4: Low-Impact Cardio \& Mobility Day 5: Full Body Integration \& Strength | Other | Sacroiliac (SI) joint exercise group |
Primary outcome
Pressure Algometer Testing
Time frame: Baseline / first month / third month / sixth month
Device: Jtech Medical 801/478 USA™ digital pressure algometer. Data collected and processed from the human algometer will generate a specific nociceptive response to neurostimulation in the somatosensory cortex. The algometer head was applied at a 90° angle to trigger points at selected locations, with pressure increased at a speed of approximately 100 g/s. One measurement was taken at the first sensation of pain, after which the process stopped.
Short Form 36
Time frame: Baseline / first month / third month / sixth month
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. Pricing depends on the number of scores that the researcher needs to calculate.
1 secondary outcome
VAS (visual analogue scale)
Time frame: Baseline / first month / third month / sixth month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Yes. Research data supporting this publication are available upon request from the authors. The datasets generated and/or analyzed during the current study are available from the corresponding author; Ali Yavuz Karahan email: ali.karahan@usak.edu.tr / mobile: +905386921934.
Related trials for Isotretinoin
Enrolling by invitationObservational study
Expert Consensus on the Use of Isotretinoin in Acne Vulgaris: A Delphi Study
Isotretinoin, Isotretinoin Adverse Reaction
Enrolling by invitationObservational study
Expert Consensus on the Use of Isotretinoin in Rejuvenation: A Delphi Study
Isotretinoin, Isotretinoin Adverse Reaction
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.
Ali Y Karahan, MD study director
Uşak University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Isotretinoin and Isotretinoin Adverse Reaction, run by Uşak University 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 4 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: looking for participants now, as of the sponsor's last update on 2 Dec 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asli K Önal, MD (+905056842590, asli.keles89@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure Algometer Testing (time frame: Baseline / first month / third month / sixth month). 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?
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 2 Dec 2025; AzTrials last refreshed its copy on 1 Nov 2026.