New Score for Pseudo- Acanthosis Nigricans

April 22, 2020 updated by: Rana F Hilal, MD, Kasr El Aini Hospital

Use Of A Novel Quantitative Tool For Evaluation of Pseudo- Acanthosis Nigricans: Acanthosis Nigricans Area And Severity Index

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Kasr El Ainy university hospital, Faulty of medicine,Cairo university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Saline
Other: Saline
Sodium chloride
Experimental: glycolic acid peel
Procedure: Glycolic acids peel 70%
Glycolic acid peel 70% applied in 3 coats medium depth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage involvement
Time Frame: 6 months to 1 year
Degree of severity expressed as a percentage
6 months to 1 year
Acanthosis Nigricans Area and Severity Index score
Time Frame: 6 months to 1 year
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
6 months to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

November 1, 2019

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

April 21, 2020

First Submitted That Met QC Criteria

April 22, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 22, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EgyANASI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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