Can a lower dose of acne drug work just as well with fewer side effects?
NCT ID NCT07639073
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a low daily dose of the acne drug isotretinoin can clear moderate to severe acne as effectively as the standard dose, but with fewer side effects. About 164 people aged 18-45 will be randomly assigned to one of two dose groups. Researchers will track acne improvement and any side effects over the treatment period.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Isotretinoin (also known as Accutane or Roaccutane)
- What this could lead to
- If successful, this could show that a lower dose of isotretinoin works just as well as the standard dose but with fewer side effects like dry skin and chapped lips.
- What could go wrong
- This is a small, early-phase trial (164 participants) in one country, so results may not apply to everyone. Lower doses might not clear acne as effectively, and side effects could still occur.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 164 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Both genders * Age 18-45 years * Patients who are clinically diagnosed with moderate to severe acne vulgaris as per criteria defined in operational definition. Exclusion Criteria: * Patients who are pregnant or lactating * Patients with history of endocrine disorders such as PCOS etc. or having drug induced acne * Patients on corticosteroid treatment * Patients who have hypersensitivity to the isotretinoin * Patients who are taking any acne treatment * Patients with hyperlipidemia, chronic renal failure or liver failure
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Pakistan Institute of Medical Sciences(PIMS)
Islamabad, Pakistan
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