New Score for Pseudo- Acanthosis Nigricans | NCT04359485

Studies
New Score for Pseudo- Acanthosis Nigricans

NCT04359485

Sponsor

Kasr El Aini Hospital

Status

Unknown status

Last Update Posted

Apr 24, 2020Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Pseudo Acanthosis Nigricans

Interventions

Glycolic acids peel 70%
Saline

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2019Actual

Primary Completion Date

Nov 1, 2019Actual

Completion Date

Jun 2020Estimated

First Submitted Date

Apr 21, 2020

First Submission Date that Met QC Criteria

Apr 22, 2020

First Posted Date

Apr 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2020

Last Update Posted Date

Apr 24, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
glycolic acid peel	Experimental		Procedure: Glycolic acids peel 70%
Saline	Placebo Comparator		Other: Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glycolic acids peel 70%	Procedure	Glycolic acid peel 70% applied in 3 coats medium depth	glycolic acid peel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage involvement	Degree of severity expressed as a percentage	6 months to 1 year
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	6 months to 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr El Ainy university hospital, Faulty of medicine,Cairo university		Cairo			Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided