NCT05779085

Brief Summary

A clinical study with 56 healthy subjects (both sexes) aged between 13 to 25 years old. Subjects enrolled had a minimum of 5 inflammatory lesions (papules, nodules and pustules) and 10 non-inflammatory lesions (open and closed comedones), determined by dermatologist. The clinical evaluation considered in oiliness, shininess and global aspect of the skin too. Instrumental assessment of oiliness and shininess was performed, respectively, by Sebumeter and Sebutape. IThe tested cleanser was used twice daily (morning and evening) during 28 days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2013

Shorter than P25 for all trials

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

April 8, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2013

Completed
9.6 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

March 7, 2023

Last Update Submit

March 9, 2023

Conditions

Acne Vulgaris on the Face

Outcome Measures

Primary Outcomes (11)

  • Global lesion count

    using GEA scale

    baseline

  • Global lesion count

    using GEA scale

    Day 28

  • Closed comedones

    count

    baseline

  • Closed comedones

    count

    Day 28

  • papules

    count

    baseline

  • papules

    count

    Day 28

  • skin oiliness

    instrumental measurement Sebumeter

    baseline

  • skin oiliness

    instrumental measurement Sebumeter

    Day 28

  • skin sebutape

    instrumental measurement Sebumeter

    baseline

  • skin sebutape

    instrumental measurement Sebumeter

    Day 28

  • subject satisfaction

    questionnaire

    Day 28

Interventions

DermocosmeticOTHER

Use of daily cleanser to treat facial acne

Also known as: Cleanser

Eligibility Criteria

Age13 Years - 26 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects aged between 13 to 25 years of age with mild to moderate acne.

You may qualify if:

  • subjects aged 13-25 years
  • mild to moderate acne on the face
  • signed informed consent

You may not qualify if:

  • subjects below 13 years and above 26 years
  • severe acne on the face

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carlos Tortely Hospital

Niterói, 20231-048, Brazil

Location

Study Design

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

Study Record Dates

First Submitted

March 7, 2023

First Posted

March 22, 2023

Study Start

April 8, 2013

Primary Completion

July 22, 2013

Study Completion

July 22, 2013

Last Updated

March 22, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)