The purpose of this study is to demonstrate the safety and efficacy of Sirolimus 0.2% topical gel for patients with Acanthosis Nigricans
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
sirolimus 0.2% gel
New York Harbor VA Brooklyn Campus
Brooklyn, New York, United States
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.
Time frame: From enrollment to end of treatment at 12 weeks
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.
Time frame: 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."
Time frame: 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.
Time frame: 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
Time frame: Week 12
Digital photography with a TwinFlash RL Clinical Camera to depict clinical improvement of acanthosis nigricans.
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Digital photography with a TwinFlash RL Clinical Camera to depict clinical improvement of AN
Time frame: Baseline to weeks 4, 8, and 12