NCT02575950

Brief Summary

An exploratory Phase 2, single, centre, prospective, randomized, placebo-controlled, double-blinded, split-pace (left/right) design trial to evaluate the efficacy and tolerability of LEO 43204 in adults with moderate to severe acne.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_2

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

First Submitted

Initial submission to the registry

October 13, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 15, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

February 28, 2019

Completed
Last Updated

March 6, 2025

Status Verified

February 1, 2019

Enrollment Period

10 months

First QC Date

October 13, 2015

Results QC Date

December 27, 2018

Last Update Submit

February 21, 2025

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

  • Total Lesion Count (Inflammatory and Non-inflammatory)

    Total lesion count (inflammatory and non-inflammatory) in acne lesion areas.

    At Week 12 (Day 84)

Secondary Outcomes (11)

  • Inflammatory Lesion Count

    At Week 12 (Day 84)

  • Non-inflammatory Lesion Count

    At Week 12 (Day 84)

  • Number of Participants Stratified by Investigator's Global Assessment (IGA) of the Treatment Area

    At Week 12 (Day 84)

  • Composite Local Skin Response (LSR) Score at All Visits

    At baseline (Day 1), Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12

  • Participant's Component LSR Score: Erosion/Ulceration

    At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12

  • +6 more secondary outcomes

Study Arms (2)

LEO43204 0,018%

EXPERIMENTAL

Experimental drug

Drug: LEO43204

Vehicle

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

LEO43204DRUG
LEO43204 0,018%
PlaceboDRUG
Vehicle

Eligibility Criteria

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

You may qualify if:

  • Subjects should be diagnosed with acne vulgaris of the face
  • Fitzpatrick skin types I-III (due to lack of safety data for the investigational product in darker skin types)
  • Disease severity and total lesion count should be similar in both TAs
  • Disease severity grade as moderate to severe according to the investigator's global assessment (grade 3-4)
  • Age 18 to 35 years incl.
  • Male or female
  • Female Subjects must be of either non-childbearing potential or child-bearing potential with a confirmed negative pregnancy test

You may not qualify if:

  • Subjects with nodulocystic acne, acne conglobata, acne fulminans, secondary acne (e.g. chlor-acne, drug-induced acne)
  • Subjects with previous history of keloid formation or post-inflammatory hyperpigmentation
  • Systemic retinoids within 12 month or systemic antibiotics within 1 month before Day 1
  • Topical retinoids within 3 months before Day 1 or other topical treatments and/or medicated products and cosmetics that in the opinion of the investigator may influence the subjects acne vulgaris (including soaps containing antibacterial agents such as benzoyl peroxide, keratinolytic agents such as salicylic acid, skin fresheners/astringents or aftershave products) within 1 month before Day 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Torrance Clinical Research Institute Inc.

Lomita, California, 90717, United States

Location

Related Links

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Results Point of Contact

Title
Clinical Trial Disclosure Manager
Organization
LEO Pharma A/S
disclosure@leo-pharma.com
+45 4494 5888

Study Officials

  • Hala Koudsi, MD

    Torrance Clinical Research Institute Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2015

First Posted

October 15, 2015

Study Start

June 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

March 6, 2025

Results First Posted

February 28, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)