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| Name | Class |
|---|---|
| Nobelpharma | INDUSTRY |
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The purpose of this study is to demonstrate the safety and efficacy of Sirolimus 0.2% topical gel for patients with Acanthosis Nigricans
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Acanthosis Nigricans | Experimental | Patients with the diagnosis of acanthosis nigricans |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus 0.2% | Drug | sirolimus 0.2% gel |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to weeks 4, 8, and 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jared Jagdeo, MD MS | SUNY Downstate Health Sciences University Department of Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Harbor VA Brooklyn Campus | Brooklyn | New York | 11209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18492785 | Background | 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. | |
| 27807348 | Background | Ding 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. |
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undecided whether IPD will be shared.
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| ID | Term |
|---|---|
| D000052 | Acanthosis Nigricans |
| ID | Term |
|---|---|
| D008548 | Melanosis |
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
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| 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." | 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. | 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 | 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 | Baseline to weeks 4, 8, and 12 |
| 30983034 | Background | Dodds 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. |
| 36943434 | Background | Treesirichod 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. |
| 25800478 | Background | Pirgon 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. |
| 30122971 | Background | Patel 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. |
| D017437 |
| Skin and Connective Tissue Diseases |