Health Condition 1: L83- Acanthosis nigricans
Conditions
Interventions
Intervention1: TOP-ANC (TM): Dose : 3ml per application
Dosage : To be applied twice a day
Treatment Duration : 30 days
Route of Administration : Topical
Control Intervention1: None. Single Arm Stud
Sponsors
Systopic Laboratories Pvt. Ltd.
Aurous HealthCare Research and Development India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged greater than equal to 18 (all genders) with acanthosis nigricans of the underarms and one other area of the body (neck, elbow, knee, groin) 2. Subjects who agree to use SPF 50+ sunscreen and are willing to avoid sunlight exposure during the study. 3. Subjects who are willing to abstain from the use of herbal allopathic or topical treatments not limited to creams, lotions, chemical peels, laser procedure that are indicated at improving or treating hyperpigmentation. 4. Subjects who are willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period. 5. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
Exclusion criteria
Exclusion criteria: 1. Subjects with known hypersensitivity or previous allergic reaction to the ingredients of the investigational products 2. Subjects who are an oral retinoids. 3. Subjects with any skin pathology or condition that could interfere with the evaluation of the investigation product. 4. Subjects with tattoo and / or piercings at the site of evaluation. 5. Subjects who have receiving any treatment for acanthosis nigricans less than 1 month prior to enrolment. 6. Subjects on remission from cancer of any type less than 5 years at the time of screening. 7. Subjects who are planning and/or currently breastfeeding. 8. Subjects who have participated in a clinical study less than 1 month before screening. 9. Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol / drug abuse, etc.), any medical condition that is unstable / poorly controlled or other factor (e.g., planned relocation) that the investigator felt would interfere with study evaluations and study participation. 10. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol 11. Subjects, who in the Opinion of the investigator are not eligible for enrolment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Acanthosis Nigricans Scoring Chart (ANSC): reduction of greater than or equal to 12 percentage by end of study. 2. Acanthosis Nigricans Area and Severity Index (ANASI): Score of lesser than or equal to 10 by end of study. 3. Investigator Global Evaluation (IGE): score of lesser than equal to 1 by end of study. 4. Patient Global Evaluation (PGE): Score of lesser than or equal to 2 by end of study. 5. Product Satisfaction Questionnaire (PSQ): Score of greater than equal to 2 by end of study. Timepoint: 1. Acanthosis Nigricans Scoring Chart (ANSC): Day 1, Day 15, Day 30 2. Acanthosis Nigricans Area and Severity Index (ANASI): Day 1, Day 15, Day 30 3. Investigator Global Evaluation(IGE): Day 15, Day 30 4. Patient Global Evaluation(PGE): Day 15, Day 30 5. Product Satisfaction Questionnaire(PSQ): Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactDr VT Sriraam
Aurous HealthCare R&D India Pvt. Ltd.
Outcome results
None listed