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Can a lower dose of acne drug work just as well with fewer side effects?

NCT ID NCT07639073

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 164 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 45 years

Sex

Anyone

Healthy volunteers

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

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.

acne Acne Vulgaris

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Pakistan Institute of Medical Sciences(PIMS)

    Islamabad, Pakistan

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