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Could a pill and gel combo restore skin color in vitiligo?
NCT ID NCT07251595
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new drug called SHR0302, given as a tablet and a gel, for people with non-segmental vitiligo. The goal is to see if it can safely and effectively bring back skin color. About 176 adults aged 18 to 75 will take part, and some will receive a placebo to compare results.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SHR0302 (a JAK inhibitor) taken as a tablet and applied as a gel
- What this could lead to
- If successful, this could offer a new treatment option to help restore skin color in people with vitiligo.
- What could go wrong
- This is an early Phase 2 trial with only 176 participants, so results may not apply to everyone. The drug may cause side effects or not work better than a placebo.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 176 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Sep 2027
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. Sign the informed consent form before the clinical trial. 2. On the day of signing the informed consent form, the age must be between 18 and 75 years old (inclusive), and it can be either male or female. 3. The subjects and their partners had no intention of having children during the study period and within one month after the administration of the drug, did not donate sperm or eggs, and voluntarily adopted effective contraceptive measures. The serum pregnancy test results of the female subjects must be negative and they must not be in the lactation period. 4. During the screening process, it was clinically diagnosed as non-segmental vitiligo. 5. Throughout the entire research process, the participants agreed to stop using all treatments related to vitiligo as well as any cosmetic products with therapeutic effects. Exclusion Criteria: 1. Subjects diagnosed with segmental, mixed or undifferentiated vitiligo; or subjects previously diagnosed with other skin pigmentation disorders. 2. When the facial skin lesions caused by vitiligo cover more than 33% of the area with white hair. 3. During the screening period or at the baseline, there were other active skin lesions or skin infections that might interfere with the use of the study drug or the evaluation of the drug's efficacy. 4. Subjects with a history of related infections/communicable diseases or infection/contagion history. 5. Known or suspected history of immunosuppression. 6. Tuberculosis (TB) or latent tuberculosis infection. 7. Positive for human immunodeficiency virus antibody HIV-Ab, positive for syphilis-specific antibody, positive for hepatitis C virus antibody HCV-Ab, or hepatitis B virus (HBV) infection. 8. Subjects who have malignant tumors or have a history of malignant tumors. 9. Abnormal thyroid function, with a history of thrombotic diseases within the previous 12 months, and having experienced a cardiovascular or cerebrovascular event that required hospitalization within the previous 12 months. 10. There are serious abnormalities in the cardiovascular, mental, renal, liver, immune, gastrointestinal, urogenital, nervous, skeletal-muscular, skin, sensory, endocrine or hematological systems. 11. Pregnant women, lactating women, or female participants who plan to become pregnant during the study period. 12. Those who are known to be allergic to the test drug or any component of the test drug.
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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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Dermatology Hospital affiliated to Shandong First Medical University
RECRUITINGJinan, Shandong, 250022, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New pill could help restore skin color in vitiligo patients
- Can a pill keep vitiligo at bay? new study aims to find out
- New hope for vitiligo: experimental drug aims to restore skin color
- New hope for vitiligo: experimental drug aims to bring back skin color