NCT06008327

Brief Summary

Acanthosis nigricans (AN) is a dermatosis with aesthetic implications and is characterized by the focal or diffuse development of a velvety, hyperpigmented cutaneous thickening in intertriginous areas. Trichloroacetic acid (TCA), a superficial chemical exfoliative agent has shown efficacy in treating acanthosis nigricans. Data from this would help in establishing it as a treatment of choice thereby lead to reduction in cost and benefit the patient both financially and psychologically.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

11 months

First QC Date

March 22, 2023

Last Update Submit

August 18, 2023

Conditions

Acanthosis Nigricans

Outcome Measures

Primary Outcomes (1)

  • EFFICACY OF TOPICAL 15%TRICHLOROACETIC ACID VERSUS 0.05% TOPICAL TRETINOIN IN ACANTHOSIS NIGRICANS

    Efficacy will be assessed by taking serials photographs before and after treatment shown efficacy in treating acanthosis nigricans. Data from this would help in establishing it as a treatment of choice thereby lead to reduction in cost and benefit the patient both financially and psychologically.

    It will be assessed upto 02 months

Study Arms (2)

Group A Topical 15% Trichloroacetic acid

EXPERIMENTAL

15 % Trichloroacetic acid (TCA) and 0.05%Tretinoin for 02 months Trichloroacetic acid, a superficial chemical exfoliative agent has shown efficacy in treating acanthosis nigricans. 9-10 Data from this would help in establishing it as a treatment of choice thereby lead to reduction in cost and benefit the patient both financially and psychologically.

Drug: Topical 15% Trichloroacetic acid

Group B Topical 0.05% Tretinoin

EXPERIMENTAL

Topical tretinoin is the first choice of drug in the treatment of acanthosis nigricans. Despite several therapeutic modalities, acanthosis nigricans (AN) remains a difficult dermatosis to treat.

Drug: Topical 15% Trichloroacetic acid

Interventions

Topical 15% Trichloroacetic acidDRUG

Recently trichloroacetic acid (TCA), a superficial chemical exfoliative agent has shown efficacy in treating acanthosis nigricans. Data from this would help in establishing it as a treatment of choice thereby lead to reduction in cost and benefit the patient both financially and psychologically.

Also known as: Topical 0.05% Tretinoin
Group A Topical 15% Trichloroacetic acidGroup B Topical 0.05% Tretinoin

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who will present with acanthosis nigricans as per operational definition will be included in the study.
  • Either gender.
  • Age 20-50 years.

You may not qualify if:

  • Pregnancy.
  • Breastfeeding.
  • Patients with history of skin resurfacing by dermabrasion, chemical peels and facial laser within the preceding 9 months.
  • Patients with history of hypersensitivity.
  • Malignant Acanthosis Nigricans.
  • Drug Induced Acanthosis Nigricans.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JPMC

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Acanthosis Nigricans

Interventions

Trichloroacetic AcidTretinoin

Condition Hierarchy (Ancestors)

MelanosisHyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ChloroacetatesAcetatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydrocarbons, ChlorinatedHydrocarbons, HalogenatedHydrocarbonsVitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Officials

  • Parisa Sanawar, FCPS

    Jpmc

    PRINCIPAL INVESTIGATOR

  • Nazia Jabeen, FCPS

    Jpmc

    PRINCIPAL INVESTIGATOR

  • Fazia Inam, FCPS

    Jpmc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 22, 2023

First Posted

August 23, 2023

Study Start

August 1, 2022

Primary Completion

June 20, 2023

Study Completion

June 20, 2023

Last Updated

August 23, 2023

Record last verified: 2023-08

Locations

PA(1)