Phase 1 study
Recruiting Phase 1
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Emeritus Research | Botany | NSW | Recruiting |
| The Skin Hospital | Darlinghurst | NSW | Not yet recruiting |
| Emeritus Research | Camberwell | VIC | Recruiting |
| Nucleus Network | Melbourne | VIC | Completed |
| Fremantle Dermatology | Fremantle | WA | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 15 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
Inclusion Criteria:
Healthy Participants (Parts A, B and C)
1. Healthy, adult, male or female 18-55 years of age
2. Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2
3. Medically healthy with no clinically significant medical history
4. Understands the study procedures in the informed consent form (ICF) and willing and able to comply with the protocol
Healthy Participants with Acne (Part D only)
Participants must meet all of the above criteria, as well as the following inclusion criteria to be eligible for participation in the study:
1. BMI ≥18.0 and ≤37.0 kg/m2.
2. Must be diagnosed with moderate to severe acne vulgaris
Exclusion Criteria:
Healthy Participants (Parts A, B and C)
1. History or presence of clinically significant medical or psychiatric condition or disease
2. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds including over the counter acne products.
3. Has a clinically significant ophthalmic examination finding
4. Female participant of childbearing potential
5. Unable to refrain from or anticipates the use of:
* Any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements
* Any topical anti-acne treatment on the face
* Any drugs known to be moderate or strong inducers of CYP3A4 enzymes, BCRP, and/or P gp, including St. John's Wort, beginning 28 days prior to the first dosing.
* Part C only: Any previous tretinoin treatments, including tazarotene, adapalene, isotretinoin, and all-trans retinoic acid.
Healthy Participants with Acne (Part D only)
Participants must not be enrolled if they do not meet any of the above criteria, as well as the following exclusion criteria:
1. Unable to refrain from or anticipates the use of:
* Any previous tretinoin treatments, including tazarotene, adapalene, isotretinoin, and all trans retinoic acid.
* Photoelectric therapy, dermabrasion, or chemical peeling
* Intra-articular and systemic corticosteroid therapy
2. Significant skin diseases
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 13 October 2026.
- This page last checked by Voxsanity: 15 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.