Acanthosis Nigricans
Conditions
Keywords
acanthosis nigricans
Brief summary
The purpose of this study is to demonstrate the safety and efficacy of Sirolimus 0.2% topical gel for patients with Acanthosis Nigricans
Interventions
DRUGSirolimus 0.2%
sirolimus 0.2% gel
Sponsors
Nobelpharma
Narrows Institute for Biomedical Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in hyperpigmentation in acanthosis nigricans lesions | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in hyperpigmentation and skin texture in acanthosis nigricans lesions | Baseline to weeks 4, 8, and 12 | 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. |
| Improvement in the Investigators Global Evaluation (IGE) scale and Patient Global Evaluation (PGE) scale | Baseline to weeks 4, 8, and 12 | 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. |
| Improvement in the Dermatology Quality of Life (DLQI) scale | From enrollment to end of treatment at 12 weeks | The DLQI ranges from 0 to 30 with higher scores denoting worse quality of life. |
| Assessment of patient satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM) | Week 12 | Assessment of patient satisfaction using the treatment satisfaction questionnaire for medication |
| Digital photography with a TwinFlash RL Clinical Camera to depict clinical improvement of acanthosis nigricans. | Baseline to weeks 4, 8, and 12 | Digital photography with a TwinFlash RL Clinical Camera to depict clinical improvement of AN |
Countries
United States
Outcome results
None listed