Back to resultsNew Score for Pseudo- Acanthosis Nigricans
Primary Purpose
Pseudo Acanthosis Nigricans
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Glycolic acids peel 70%
Saline
Sponsored by
About this trial
This is an interventional other trial for Pseudo Acanthosis Nigricans
Eligibility Criteria
Inclusion Criteria:
- mild to moderate severity
- age > 18 years old
Exclusion Criteria:
- Pregnant and lactating patients,
- patients with systemic diseases as connective tissue disease, diabetes,
- skin infection
- use of immunosuppressive drugs
- Susceptibility for post peel hazards as hyperpigmentation
- scarring and keloidal tendency
Sites / Locations
- Kasr El Ainy university hospital, Faulty of medicine,Cairo university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
glycolic acid peel
Saline
Arm Description
Outcomes
Primary Outcome Measures
Percentage involvement
Degree of severity expressed as a percentage
Acanthosis Nigricans Area and Severity Index score
New Score calculating severity and area as a number minimum value is 0 and maximum value is 40 the higher the number of the score the worse the affection
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04359485
Brief Title
New Score for Pseudo- Acanthosis Nigricans
Official Title
Use Of A Novel Quantitative Tool For Evaluation of Pseudo- Acanthosis Nigricans: Acanthosis Nigricans Area And Severity Index
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Each side of the neck pseudo acanthosis nigricans was randomized in to either receiving glycolic acid peel or saline. Evaluation was done at baseline and after 3 sessions 2 weeks apart by percentage involvement and by ANASI score
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudo Acanthosis Nigricans
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
glycolic acid peel
Arm Type
Experimental
Arm Title
Saline
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Glycolic acids peel 70%
Intervention Description
Glycolic acid peel 70% applied in 3 coats medium depth
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
Sodium chloride
Primary Outcome Measure Information:
Title
Percentage involvement
Description
Degree of severity expressed as a percentage
Time Frame
6 months to 1 year
Title
Acanthosis Nigricans Area and Severity Index score
Description
New Score calculating severity and area as a number minimum value is 0 and maximum value is 40 the higher the number of the score the worse the affection
Time Frame
6 months to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
mild to moderate severity
age > 18 years old
Exclusion Criteria:
Pregnant and lactating patients,
patients with systemic diseases as connective tissue disease, diabetes,
skin infection
use of immunosuppressive drugs
Susceptibility for post peel hazards as hyperpigmentation
scarring and keloidal tendency
Facility Information:
Facility Name
Kasr El Ainy university hospital, Faulty of medicine,Cairo university
City
Cairo
Country
Egypt
12. IPD Sharing Statement
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New Score for Pseudo- Acanthosis Nigricans
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