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Generic acne gel put to the test in large trial

NCT ID NCT07469228

Disease control Sponsor: Sun Pharmaceutical Industries, Inc. Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 completed Phase 1 trial compared a generic tretinoin gel (0.04%) to the brand-name RETIN-A MICRO for treating acne vulgaris. Over 1,000 participants aged 12 to 40 with mild to moderate acne applied the gel daily for 12 weeks. The goal was to see if the generic version works just as well and is as safe as the original.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tretinoin gel microsphere, 0.04%
What this could lead to
If successful, this could show that the generic tretinoin gel works as well as the brand-name version for treating acne.
What could go wrong
This is an early Phase 1 trial focused on equivalence, not a new breakthrough. Results may not confirm the generic is as effective or safe as the reference drug.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

1,043 people

The number who actually took part.

Started

Aug 2025

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 40 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris. * Subjects who are 18 years of age or older must have provided IRB approved written informed consent. * Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3 or 4 as per the Investigator's Global Assessment (IGA). * Subjects must have ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤ 2 nodulocystic lesions (i.e., nodules and cysts), at baseline on the face. Exclusion Criteria: * Female Subjects who are pregnant, nursing or planning to become pregnant during study participation. * Subjects with a history of hypersensitivity or allergy to tretinoin, retinoids, or any of the study medication ingredients. * Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis). * Subjects with a baseline irritation score of 3 = severe (marked, intense). * Subjects with eczematous skin.

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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.

Acne vulgaris

Contacts and locations

Locations

  • Sun Pharmaceutical Industries, Inc.

    Hawthorne, New York, 10532, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.