New Score for Pseudo- Acanthosis Nigricans

• Sponsor: Kasr El Aini Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04359485
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 10
• Patients Per Site Per Month: 2

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Pseudo Acanthosis Nigricans	Procedure: Glycolic acids peel 70%; Other: Saline	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Use Of A Novel Quantitative Tool For Evaluation of Pseudo- Acanthosis Nigricans: Acanthosis Nigricans Area And Severity Index
• Actual Study Start Date: Aug 1, 2019
• Actual Primary Completion Date: Nov 1, 2019
• Anticipated Study Completion Date: Jun 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage involvement [6 months to 1 year]

   Degree of severity expressed as a percentage

2. Acanthosis Nigricans Area and Severity Index score [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasr El Ainy university hospital, Faulty of medicine,Cairo university	Cairo		Egypt

Sponsors and Collaborators

• Kasr El Aini Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rana F Hilal, MD, Principal Investigator, Kasr El Aini Hospital
• ClinicalTrials.gov Identifier: NCT04359485
• Other Study ID Numbers: EgyANASI
• First Posted: Apr 24, 2020
• Last Update Posted: Apr 24, 2020
• Last Verified: Apr 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acanthosis Nigricans; Glycolic acid

Study Results

No Results Posted as of Apr 24, 2020