NCT01688531

Brief Summary

Exploratory, international, multi-centre, randomized, investigator blinded study in acne

Trial Health

90
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2012

Geographic Reach
2 countries

3 active sites

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

August 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

September 18, 2019

Status Verified

March 1, 2016

Enrollment Period

1.1 years

First QC Date

September 17, 2012

Last Update Submit

September 16, 2019

Conditions

Acne

Outcome Measures

Primary Outcomes (1)

  • Description and documentation of acne lesions

    over 6 months

Secondary Outcomes (1)

  • Treatment effect on acne lesions

    over 6 months

Study Arms (2)

CD0271 0.1%/CD1579 2.5% gel

EXPERIMENTAL

Split-face design, one application a day for 6 months

Drug: CD0271 0.1%/CD1579 2.5% gel vehicle

CD0271 0.1%/CD1579 2.5% gel vehicle

PLACEBO COMPARATOR

Split-face design, one application a day for 6 months

Drug: CD0271 0.1%/CD1579 2.5% gel

Interventions

CD0271 0.1%/CD1579 2.5% gelDRUG

one application (pea-sized amount according to the labelling) on a half-face, 5 to 7 days for 6 months

CD0271 0.1%/CD1579 2.5% gel vehicle
CD0271 0.1%/CD1579 2.5% gel vehicleDRUG

one application (pea-sized amount according to the labelling) on a half-face, 5 to 7 days for 6 months

CD0271 0.1%/CD1579 2.5% gel

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female subjects aged 18 to 35 years inclusive
  • Subjects with active, moderate acne

You may not qualify if:

  • The subject has a secondary acne form (chloracne, drug-induced acne, etc.) (Screening)
  • The subject has a severity of acne that is not amenable to treatment with CD0271-CD1579 (Screening)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Galderma Investigational site

Windsor, Ontario, Canada

Location

Galderma Investigational site

Montreal, Quebec, Canada

Location

Galderma Investigational site

Nantes, France

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Gels

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2012

First Posted

September 20, 2012

Study Start

August 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

September 18, 2019

Record last verified: 2016-03

Locations

CA(2)FR(1)