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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).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Ali Y karahan, MD contact

+905386921934

ali.karahan@usak.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Usak University

    Uşak, 64200

    Ali Y Karahan, MD, +905386921934, ali.karahan@usak.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

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.

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 groups in NCT07196787
Study groupRoleWhat they receive
Sacroiliac (SI) joint exercise groupExperimentalThis 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 groupNo interventionControl group: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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)
  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.

  1. First posted29 Sep 2025
  2. Study start30 Sep 2025
  3. Primary completion6 Feb 2026 (estimated)
  4. Study completion26 Mar 2026 (estimated)

Resources

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)
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.

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.

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