NCT05712837

Brief Summary

To compare the efficacy of 25% trichloroacetic acid peel versus 30% salicylic acid peel in mild to moderate acne vulgaris. Study Design: Randomized Control Trial. Place And Duration of Study: Department of Dermatology, CMH Abbottabad from 01 Jun 2022 to 30th Nov, 2022. Methodology: A total of 60 patients presented with mild or moderate acne vulgaris were randomized into two groups comprising 30 patients in each group and treated with either the TCA peel or the SA peel at 2-week intervals for 12 weeks. Patients in Group A were treated with 25% TCA peel whereas patients in Group B were treated with 30% SA peel. At the end of therapy after 12 weeks, evaluation of active acne was done by individual lesion counts (comedones, papules and pustules) and calculation of the Michaelsson acne score (MAS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
Last Updated

February 6, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

January 18, 2023

Last Update Submit

January 26, 2023

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of 25 % trichloroacetic acid peel versus 30 % salicylic acid peel in the treatment of mild to moderate acne vulgaris

    Michaelson acne scores (MAS) Michaelson acne scores (MAS) was used to measure the effectiveness of both peels

    12 weeks

Study Arms (2)

Group A 25% TCA

ACTIVE COMPARATOR

25% TCA peel Patients of group A were treated with 25% TCA peel and patients at 2-week intervals for a total of 12 weeks. Clinical evaluation was done at the end of therapy after 12-weeks of treatment.

Drug: 25% TRICHLOROACETIC ACID

Group B 30% SALICYLIC ACID

ACTIVE COMPARATOR

30% SA peels Patients of group B were treated with 30 % salicylic acid peel and patients at 2 weeks interval for a total of 12 weeks.clinical evaluation was done at the end of therapy after 12 weeks of treatment

Drug: 30% salicylic acid

Interventions

25% TRICHLOROACETIC ACIDDRUG

Patients of group A were treated with 25% TCA peel and patients at 2-week intervals for a total of 12 weeks. Clinical evaluation was done at the end of therapy after 12-weeks of treatment.

Also known as: Peeling agent
Group A 25% TCA
30% salicylic acidDRUG

Patients of group B were treated with 30 % salicylic acid peel and patients at 2 weeks interval for a total of 12 weeks.clinical evaluation was done at the end of therapy after 12 weeks of treatment

Also known as: Peeling agent
Group B 30% SALICYLIC ACID

Eligibility Criteria

Age13 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with mild or moderate facial acne vulgaris presented in dermatology opd

You may not qualify if:

  • Patients with grade III or IV acne vulgaris
  • patients taking any acne medications or had taken oral or topical medications in the past 4 weeks
  • pregnant female patients or nursing a baby
  • patients with known hypersensitivity to the formulations used in the study or a history of photosensitivity
  • hypertrophic scars, keloidal tendency, active or recurrent herpes simplex infection
  • active dermatosis
  • unrealistic expectations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cmh abbottabad

Abbottābād, Kpk, 22010, Pakistan

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Trichloroacetic AcidSalicylic Acid

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

ChloroacetatesAcetatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydrocarbons, ChlorinatedHydrocarbons, HalogenatedHydrocarbonsSalicylatesHydroxybenzoatesBenzoatesAcids, CarbocyclicHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicPhenols

Study Design

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

Study Record Dates

First Submitted

January 18, 2023

First Posted

February 6, 2023

Study Start

June 1, 2022

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

February 6, 2023

Record last verified: 2023-01

Locations

PA(1)