NCT04359485

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

April 21, 2020

Last Update Submit

April 22, 2020

Conditions

Pseudo Acanthosis Nigricans

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

glycolic acid peel

EXPERIMENTAL
Procedure: Glycolic acids peel 70%

Saline

PLACEBO COMPARATOR
Other: Saline

Interventions

Glycolic acids peel 70%PROCEDURE

Glycolic acid peel 70% applied in 3 coats medium depth

glycolic acid peel
SalineOTHER

Sodium chloride

Saline

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • mild to moderate severity
  • age \> 18 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Cairo, Egypt

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 21, 2020

First Posted

April 24, 2020

Study Start

August 1, 2019

Primary Completion

November 1, 2019

Study Completion

June 1, 2020

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations

EG(1)