NCT05584150

Brief Summary

Acne vulgaris is a chronic inflammatory disease, mainly of the face, but also of the trunk. Acne may be caused by internal and external factors. Only a very small amount of data exists concerning truncal acne. The condition affects about 9% of the population worldwide, with 50% of subjects with facial acne also presenting with truncal acne. Until recently, clinicians frequently followed the same therapeutic approach as for facial acne, with treatment adherence remaining an issue. This study assessed assessed the benefit of a cleansing gel containing salicylic acid 2%, zinc gluconate 0.2% and Lipo hydroxy acids (LHA) 0.05%, used daily for 84 days in mild to moderate truncal acne.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

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

October 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
Last Updated

October 18, 2022

Status Verified

September 1, 2022

Enrollment Period

1.2 years

First QC Date

September 25, 2022

Last Update Submit

October 14, 2022

Conditions

Keywords

truncal acne

Outcome Measures

Primary Outcomes (3)

  • Investigator global assessment

    Scale 0=absent to 5=very serious

    baseline

  • Investigator global assessment

    Scale 0=absent to 5=very serious

    Day 42

  • Investigator global assessment

    Scale 0=absent to 5=very serious

    Day 84

Secondary Outcomes (21)

  • inflammatory lesion count

    baseline

  • inflammatory lesion count

    Day 42

  • inflammatory lesion count

    Day 84

  • non-inflammatory lesion count

    baseline

  • non-inflammatory lesion count

    Day 42

  • +16 more secondary outcomes

Interventions

daily use

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult female or males with subjects with truncal acne

You may qualify if:

  • above 18 years
  • truncal acne

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIDP

Rio de Janeiro, 20231-048, Brazil

Location

Related Publications (1)

  • Towersey L, Correia P, Fajgenbaum Feiges M, Euzebio Goncalves Junior J, Sant'Anna B, Kerob D, Le Floc'h C. Assessment of the Benefit of a Deep Cleansing Gel Containing Salicylic Acid 2%, Zinc Gluconate 0.2% and Lipohydroxy Acids 0.05% in Patients with Mild to Moderate Truncal Acne: Results from an Exploratory Study. Clin Cosmet Investig Dermatol. 2023 Jan 18;16:119-123. doi: 10.2147/CCID.S394123. eCollection 2023.

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Delphine Kerob, MD

    La Roche-Posay Laboratoire Dermatologique

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2022

First Posted

October 18, 2022

Study Start

October 1, 2019

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

October 18, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations