New drug aims to restore skin color in vitiligo patients
NCT ID NCT06905873
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests a new drug called FB102 in 64 adults with non-segmental vitiligo, a condition that causes white patches on the skin. Half will get the drug and half a placebo, both given by IV. The main goal is to check safety and see if the drug helps bring back skin color on the face.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FB102 (a drug given by IV infusion)
- What this could lead to
- If it works, this could point toward a new treatment to restore skin color in people with vitiligo.
- What could go wrong
- This is a very early Phase 1 trial with only 64 people, so it is primarily checking safety. It may not show clear benefit, and side effects are unknown.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 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: 1. Males and females aged ≥ 18 to 75 years at time of Screening. 2. Must have confirmed non-segmental vitiligo criteria at the Screening Visit and the Baseline Visit, as assessed by the study investigator. 3. If receiving concomitant medications for any reason other than vitiligo, must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1. Participant must be willing to stay on a stable regimen during the duration of the study. Note: There are additional inclusion criteria. The study center will determine if participant meets all of the criteria Exclusion Criteria: 1. Currently have active forms of other hypopigmentation (including but not limited to Vogt-Koyanagi-Harada disease, malignancy-induced hypopigmentation \[melanoma and mycosis fungoides\], post-inflammatory hypopigmentation, pityriasis alba \[minor manifestation of atopic dermatitis\], senile leukoderma \[age-related depigmentation\], chemical/drug-induced leukoderma, ataxia telangiectasia, tuberous sclerosis, melasma, and congenital hypopigmentation disorders including piebaldism, Waardenburg syndrome, hypomelanosis of Ito, incontinentia pigmenti, dyschromatosis symmetrica hereditaria, xeroderma pigmentosum, and nevus depigmentosus). 2. Currently have active forms of inflammatory skin disease(s) or evidence of skin conditions (including but not limited to morphea, discoid lupus, leprosy, syphilis, psoriasis, seborrheic dermatitis) at the time of the Screening or Day 1 Visit that in the opinion of the investigator would interfere with evaluation of vitiligo or response to treatment. 3. Greater than approximately 33% leukotrichia (depigmentation of the hair) in areas of vitiligo on the face as assessed by a healthcare professional at the time of screening. Note: There are additional exclusion criteria. The study center will determine if participant meets all of the criteria
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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
6 sites in 2 countries. 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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Cornerstone Dermatology
RECRUITINGCoorparoo, Queensland, 4151, Australia
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Momentum Pukehoke
RECRUITINGAuckland, Auckland, 2120, New Zealand
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Novatrials
RECRUITINGKotara, New South Wales, 2289, Australia
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Optimal Clinical Trials Central
RECRUITINGAuckland, Auckland, 1010, New Zealand
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Optimal Clinical Trials North
RECRUITINGAuckland, Auckland, 0632, New Zealand
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Skin & Cancer Foundation Australia - The Skin Hospital
RECRUITINGDarlinghurst, New South Wales, 2010, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a skin cream bring back color to faces with vitiligo?
- Skin markers may reveal how light therapy fights vitiligo
- Can Real-World data unlock better skin disease care?
- New ointment aims to restore skin color in vitiligo
- Skin microbes linked to vitiligo and immunotherapy reactions in melanoma patients
- New vitiligo registry aims to uncover disease trends in 2,500 patients