Acanthosis NigricansPhase 2NCT06940895
Evaluating the Safety and Efficacy of Topical Sirolimus 0.2% to Treat Acanthosis Nigricans
A Phase 2 study testing Sirolimus 0.2% in people with Acanthosis Nigricans, run by Narrows Institute for Biomedical Research at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate the safety and efficacy of Sirolimus 0.2% topical gel for patients with Acanthosis Nigricans Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acanthosis Nigricans
- What is being tested?
- Sirolimus 0.2%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 18 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ages 18+.
- Clinical diagnosis of acanthosis nigricans.
- Available and willing to comply with study instructions and attend all study visits.
- Able and willing to provide written and verbal informed consent.
Who cannot join
- Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy.
- Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- Pregnant, lactating, or is planning to become pregnant during the study.
- Subject is currently enrolled in an investigational drug or device study.
- Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (baseline).
- Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
Show all 14Show fewer
- Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles.
- Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial.
- Erosions, ulcers, or other skin lesions within or closely neighboring the AN lesion application site.
- Hypersensitivity reactions such as anaphylaxis or angioedema to sirolimus or any component of sirolimus 0.2% topical gel (HYFTOR).
- Dyslipidemia (cholesterol level >300mg/dL or >7.75mmol/L, triglyceride level >300 mg/dL or >3.42 mmol/L).
- Subject cannot agree to take appropriate contraception for the duration of the study and 12 weeks after the final dose.
- Exclusions apply to those who have used the following topical treatments to treat AN: retinoids, hydroquinones, corticosteroids, or other depigmenting agents within one month prior to the study, or oral retinoids within six months prior to the study, or medications with mammalian target of rapamycin(mTOR) inhibitory action within 12 months prior to the first visit.
- Subjects with a malignant tumor
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Harbor VA Brooklyn Campus
Brooklyn, New York, 11209
About this study
The purpose of this study is to demonstrate the safety and efficacy of Sirolimus 0.2% topical gel for patients with Acanthosis Nigricans
- Conditions
- Acanthosis Nigricans
- Being tested
- Sirolimus 0.2%
- Keywords
- acanthosis nigricans
- Medical subject headings
- Acanthosis Nigricans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus 0.2%Drug
Also called HYFTOR
sirolimus 0.2% gel
| Study group | Role | What they receive |
|---|---|---|
| Patients with Acanthosis Nigricans | Experimental | Patients with the diagnosis of acanthosis nigricans Receives: Drug: Sirolimus 0.2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in hyperpigmentation in acanthosis nigricans lesions
Improvement in the Melanin(M) index from baseline to 12 weeks of treatment. The M index is positively correlated with a darker skin color and ranges from 0-999.
Measured: From enrollment to end of treatment at 12 weeks
Secondary outcomes (5)
Improvement in hyperpigmentation and skin texture in acanthosis nigricans lesions
Improvement in the ANSC (Acanthosis Nigricans Scoring Chart) from baseline (Day 0) to Visit 2 (Week 4), Visit 3 (Week 8) and Visit 4 (Week 12). ANSC is scored on a scale of 1 to 8 for skin color and 1 to 6 for skin texture. These scores are then combined for a total ANSC score ranging from 2 to 14.
Measured: Baseline to weeks 4, 8, and 12
Improvement in the Investigators Global Evaluation (IGE) scale and Patient Global Evaluation (PGE) scale
IGE and PGE are both scored on a 0 to 6 scale: 0 signifies "clear," 1 indicates "almost clear or > 90% improvement," 2 represents "marked improvement or 75% improvement," 3 denotes "moderate improvement or 50% improvement," 4 signifies "mild improvement or 25% improvement," 5 indicates "no change," and 6 means "worsening."
Measured: Baseline to weeks 4, 8, and 12
Improvement in the Dermatology Quality of Life (DLQI) scale
The DLQI ranges from 0 to 30 with higher scores denoting worse quality of life.
Measured: From enrollment to end of treatment at 12 weeks
Assessment of patient satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM)
Assessment of patient satisfaction using the treatment satisfaction questionnaire for medication
Measured: Week 12
Digital photography with a TwinFlash RL Clinical Camera to depict clinical improvement of acanthosis nigricans.
Digital photography with a TwinFlash RL Clinical Camera to depict clinical improvement of AN
Measured: Baseline to weeks 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start1 Mar 2025
- Primary completion8 Jul 2025
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acanthosis NigricansStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Narrows Institute for Biomedical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Nobelpharma
- Responsible party
- Sponsor
- Investigators
- Jared Jagdeo, MD MS, Principal investigator, SUNY Downstate Health Sciences University Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940895
- Sponsor's protocol ID
- 1814310
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided whether IPD will be shared.
Publications
Romo A, Benavides S. Treatment options in insulin resistance obesity-related acanthosis nigricans. Ann Pharmacother. 2008 Jul;42(7):1090-4. doi: 10.1345/aph.1K446. Epub 2008 May 20.
PubMed 18492785Ding X, Bloch W, Iden S, Ruegg MA, Hall MN, Leptin M, Partridge L, Eming SA. mTORC1 and mTORC2 regulate skin morphogenesis and epidermal barrier formation. Nat Commun. 2016 Oct 27;7:13226. doi: 10.1038/ncomms13226.
PubMed 27807348Dodds M, Maguiness S. Topical sirolimus therapy for epidermal nevus with features of acanthosis nigricans. Pediatr Dermatol. 2019 Jul;36(4):554-555. doi: 10.1111/pde.13833. Epub 2019 Apr 15.
PubMed 30983034Treesirichod A, Thaneerat N, Kangvanskol W. A comparison of the efficacy and safety profiles of 10% salicylic acid and 10% urea creams in treating acanthosis nigricans in adolescents: a randomized double-blinded study. Arch Dermatol Res. 2023 Sep;315(7):2091-2097. doi: 10.1007/s00403-023-02605-6. Epub 2023 Mar 21.
PubMed 36943434Pirgon O, Sandal G, Gokcen C, Bilgin H, Dundar B. Social anxiety, depression and self-esteem in obese adolescent girls with acanthosis nigricans. J Clin Res Pediatr Endocrinol. 2015 Mar;7(1):63-8. doi: 10.4274/jcrpe.1515.
PubMed 25800478Patel NU, Roach C, Alinia H, Huang WW, Feldman SR. Current treatment options for acanthosis nigricans. Clin Cosmet Investig Dermatol. 2018 Aug 7;11:407-413. doi: 10.2147/CCID.S137527. eCollection 2018.
PubMed 30122971
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Efficacy of Topical Sirolimus 0.2% to Treat Acanthosis Nigricans
- ClinicalTrials.gov ID
- NCT06940895
- Acronym / sponsor ID
- 1814310
- Conditions
- Acanthosis Nigricans
- Keywords
- acanthosis nigricans
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Narrows Institute for Biomedical ResearchUniversity, hospital or other
- Collaborators
- Nobelpharma
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 8 Jul 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate the safety and efficacy of Sirolimus 0.2% topical gel for patients with Acanthosis Nigricans
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Acanthosis Nigricans | Experimental | Drug: Sirolimus 0.2%Patients with the diagnosis of acanthosis nigricans |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women ages 18+.
- Clinical diagnosis of acanthosis nigricans.
- Available and willing to comply with study instructions and attend all study visits.
- Able and willing to provide written and verbal informed consent.
Key exclusion criteria (14 listed)
- Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy.
- Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- Pregnant, lactating, or is planning to become pregnant during the study.
- Subject is currently enrolled in an investigational drug or device study.
- Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (baseline).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sirolimus 0.2%Also: HYFTORsirolimus 0.2% gel | Drug | Patients with Acanthosis Nigricans |
Primary outcome
Improvement in hyperpigmentation in acanthosis nigricans lesions
Time frame: From enrollment to end of treatment at 12 weeks
Improvement in the Melanin(M) index from baseline to 12 weeks of treatment. The M index is positively correlated with a darker skin color and ranges from 0-999.
5 secondary outcomes
Improvement in hyperpigmentation and skin texture in acanthosis nigricans lesions
Time frame: Baseline to weeks 4, 8, and 12
Improvement in the Investigators Global Evaluation (IGE) scale and Patient Global Evaluation (PGE) scale
Time frame: Baseline to weeks 4, 8, and 12
Improvement in the Dermatology Quality of Life (DLQI) scale
Time frame: From enrollment to end of treatment at 12 weeks
Assessment of patient satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: Week 12
Digital photography with a TwinFlash RL Clinical Camera to depict clinical improvement of acanthosis nigricans.
Time frame: Baseline to weeks 4, 8, and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Background: PubMed 18492785Romo A, Benavides S. Treatment options in insulin resistance obesity-related acanthosis nigricans. Ann Pharmacother. 2008 Jul;42(7):1090-4. doi: 10.1345/aph.1K446. Epub 2008 May 20.
- Background: PubMed 27807348Ding X, Bloch W, Iden S, Ruegg MA, Hall MN, Leptin M, Partridge L, Eming SA. mTORC1 and mTORC2 regulate skin morphogenesis and epidermal barrier formation. Nat Commun. 2016 Oct 27;7:13226. doi: 10.1038/ncomms13226.
- Background: PubMed 30983034Dodds M, Maguiness S. Topical sirolimus therapy for epidermal nevus with features of acanthosis nigricans. Pediatr Dermatol. 2019 Jul;36(4):554-555. doi: 10.1111/pde.13833. Epub 2019 Apr 15.
- Background: PubMed 36943434Treesirichod A, Thaneerat N, Kangvanskol W. A comparison of the efficacy and safety profiles of 10% salicylic acid and 10% urea creams in treating acanthosis nigricans in adolescents: a randomized double-blinded study. Arch Dermatol Res. 2023 Sep;315(7):2091-2097. doi: 10.1007/s00403-023-02605-6. Epub 2023 Mar 21.
- Background: PubMed 25800478Pirgon O, Sandal G, Gokcen C, Bilgin H, Dundar B. Social anxiety, depression and self-esteem in obese adolescent girls with acanthosis nigricans. J Clin Res Pediatr Endocrinol. 2015 Mar;7(1):63-8. doi: 10.4274/jcrpe.1515.
- Background: PubMed 30122971Patel NU, Roach C, Alinia H, Huang WW, Feldman SR. Current treatment options for acanthosis nigricans. Clin Cosmet Investig Dermatol. 2018 Aug 7;11:407-413. doi: 10.2147/CCID.S137527. eCollection 2018.
- Individual participant dataSharing planned: Undecided. undecided whether IPD will be shared.
Related trials for Acanthosis Nigricans
Not yet recruitingPhase 1
Efficacy and Safety Of Fractional Carbon Dioxide Laser Plus Topical Metformin In Treatment Of Acanthosis Nigricans
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Active, not recruitingPhase 2
Effect of Metreleptin Therapy in the Treatment of Severe Insulin Resistance
Severe Insulin Resistance
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jared Jagdeo, MD MS principal investigator
SUNY Downstate Health Sciences University Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sirolimus 0.2% in people with Acanthosis Nigricans, run by Narrows Institute for Biomedical Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in hyperpigmentation in acanthosis nigricans lesions (time frame: From enrollment to end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06940895, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.