Explorative Trial Evaluating the Efficacy and Tolerability of LEO43204 in Moderate to Severe Acne

A Phase 2 study testing LEO43204 in people with Acne Vulgaris, run by LEO Pharma at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 35 years
Conditions the study is for: Acne Vulgaris
What is being tested?: LEO43204
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 59 participants
Where: 1 siteUnited States
Study dates: Jun 2016to Apr 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Torrance Clinical Research Institute Inc.
Lomita, California, 90717

Other trials in United States

About this study

Official title: Explorative Trial Evaluating the Efficacy and Tolerability of LEO43204 Applied in a Split-face (Left/Right) Topical Design in Adults With Moderate to Severe Acne

Conditions: Acne Vulgaris
Being tested: LEO43204, Placebo
Medical subject headings: Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LEO43204Drug
PlaceboDrug

Study groups in NCT02575950
Study group	Role	What they receive
LEO43204 0,018%	Experimental	Experimental drug Receives: Drug: LEO43204
Vehicle	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Lesion Count (Inflammatory and Non-inflammatory)
Total lesion count (inflammatory and non-inflammatory) in acne lesion areas.
Measured: At Week 12 (Day 84)

Secondary outcomes (11)

Inflammatory Lesion Count
Count of inflammatory lesions in acne lesion areas
Measured: At Week 12 (Day 84)
Non-inflammatory Lesion Count
Count of non-inflammatory lesions in acne lesion areas
Measured: At Week 12 (Day 84)
Number of Participants Stratified by Investigator's Global Assessment (IGA) of the Treatment Area
The IGA score was determined according to the 5 point scale below.
0=Clear skin with no inflammatory and non-inflammatory lesions
1. Almost clear; rare non-inflammatory lesions with no more than one small inflammatory lesion
2. Mild severity; greater than Grade 1; some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions)
3. Moderate severity; greater than Grade 2; up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesions
4. Severe; greater than Grade 3; up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions
Measured: At Week 12 (Day 84)
Composite Local Skin Response (LSR) Score at All Visits
The Local Skin Responses consists of the following 6 components: erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR component is given a numeric grade of severity from 0-4. Grade 0 being no presence and Grade 4 being the highest grade of severity. The composite LSR score (0-24) is the sum of the scores graded from 0 to 4 on all six individual LSR categories.
Please see following outcome measure descriptions on the grading scale for the individual components:
- Erosion/ulceration: 6. Secondary outcome measure
- Crusting: 7. Secondary outcome measure.
- Erythema: 8. Secondary outcome measure.
- Flaking/scaling: 9. Secondary outcome measure.
- Swelling: 10. Secondary outcome measure.
- Vesiculation/pustulation: 11. Secondary outcome measure.
Measured: 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
The Erosion/Ulceration score was determined according to the 5 point scale below.
0=not present
1. Lesion specific erosion
2. Erosion extending beyond individual lesions
3. Erosion >50%
4. Black eschar or ulceration
Measured: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Participant's Component LSR Score: Crusting
The crusting score was determined according to the 5 point scale below.
0=not present
1. isolated crusting
2. Crusting<50%
3. Crusting>50%
4. Crusting extending outside treatment area
Measured: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Participant's Component LSR Score: Erythema
The erythema score was determined according to the 5 point scale below. Erythema 0=not present
1. slightly pink <50%
2. Pink or light red >50%
3. Red,restricted to treatment area
4. Red extending outside treatment area
Measured: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Participant's Component LSR Score: Flaking/Scaling
The flaking/scaling score was determined according to the 5 point scale below. 0=not present
1. Isolated scale, specific to lesion
2. Scale<50%
3. Scale>50%
4. Scaling extending outside treatment area
Measured: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Participant's Component LSR Score: Swelling
The swelling score was determined according to the 5 point scale below. 0=Not present
1. Slight, lesion specific oedema
2. Palpable oedema extending beyond individual lesions
3. Confluent and/or visible oedema
4. Marked swelling extending outside treatment area
Measured: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Participant's Component LSR Score: Vesiculation/Pustulation
The vesiculation/postulation score was determined according to the 5 point scale below.
0=not present
1. vesicles only
2. Transudate or pustulates with or without vesicles <50%
3. Transudate or pustulates, with or without vesicles >50%
4. Transudate or pustulates, with or without vesicles extending outside treatment area
4=Marked swelling extending outside treatment area
Measured: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Number of Participants With Occurrence of Unacceptable LSR Scores or Unacceptable Safety and Tolerability Events at All Visits
Unacceptable LSRs, safety and tolerability in an individual participant were defined as:
1. Clinically relevant signs or symptoms that in the opinion of the investigator were deemed unacceptable.
2. Occurrence of LSRs as specified below:
One of the following
- Grade 4 crusting
- Grade 4 erosion/ulceration
- Grade 4 vesiculation/pustulation extending significantly outside treatment areas
Two of the following
- Grade 4 erythema
- Grade 3 crusting
- Grade 4 swelling extending significantly outside treatment areas
- Grade 3 erosion/ulceration
- Grade 3 vesiculation/pustulation
Measured: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2016Apr 2017

First posted15 Oct 2015 (estimated)
Study startJun 2016
Primary completionApr 2017
Study completionApr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acne VulgarisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02575950
Sponsor's protocol ID: EXP-1223
Status last verified: Feb 2019
First submitted: 13 Oct 2015
Last updated: 6 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Explorative Trial Evaluating the Efficacy and Tolerability of LEO43204 Applied in a Split-face (Left/Right) Topical Design in Adults With Moderate to Severe Acne
ClinicalTrials.gov ID: NCT02575950
Acronym / sponsor ID: EXP-1223
Conditions: Acne Vulgaris
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 59 participants (actual)
Lead sponsor: LEO PharmaIndustry (pharma, biotech, devices)
Study start: Jun 2016
Primary completion: Apr 2017 (actual)
Study completion: Apr 2017 (actual)
First posted: 15 Oct 2015 (estimated)
Results: Posted 28 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
LEO43204 0,018%	Experimental	Drug: LEO43204Experimental drug
Vehicle	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LEO43204	Drug	LEO43204 0,018%
Placebo	Drug	Vehicle

Primary outcome

Total Lesion Count (Inflammatory and Non-inflammatory)
Time frame: At Week 12 (Day 84)
Total lesion count (inflammatory and non-inflammatory) in acne lesion areas.

11 secondary outcomes

Inflammatory Lesion Count
Time frame: At Week 12 (Day 84)
Non-inflammatory Lesion Count
Time frame: At Week 12 (Day 84)
Number of Participants Stratified by Investigator's Global Assessment (IGA) of the Treatment Area
Time frame: At Week 12 (Day 84)
Composite Local Skin Response (LSR) Score at All Visits
Time frame: 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
Time frame: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Participant's Component LSR Score: Crusting
Time frame: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Participant's Component LSR Score: Erythema
Time frame: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Participant's Component LSR Score: Flaking/Scaling
Time frame: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Participant's Component LSR Score: Swelling
Time frame: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Participant's Component LSR Score: Vesiculation/Pustulation
Time frame: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Number of Participants With Occurrence of Unacceptable LSR Scores or Unacceptable Safety and Tolerability Events at All Visits
Time frame: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12

Results and safety

Results posted to the registry on 28 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1	3	3
Cohort 2	6	5
Cohort 3	6	6
Cohort 4	25	20

Primary outcome: Total Lesion Count (Inflammatory and Non-inflammatory)

Time frame: At Week 12 (Day 84). Least squares mean (95% Confidence Interval). Unit: Lesions

Measure	LEO 43204 0.018% n = 38	Vehicle n = 38
Value	23.57 (19.85 to 27.29)	32.90 (29.18 to 36.62)

LEO 43204 0.018% vs Vehicle: Mean Difference (Final Values): -9.34 (95% CI -14.71 to -3.96), p <.001, ANCOVA

Population analysed: The analysis was based on the full analysis set (FAS). At Week 12, FAS comprised 32 subjects as 6 subjects discontinued before Week 12. The overall number of participants analyzed is irrespective of the number of participants providing data or not.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline (Day 1) to post treatment follow-up (end of treatment to Week 12). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Non-cutaneous	0 of 40 (0%)	2 of 40 (5%)	0 of 40
LEO 43204 0.018%	0 of 40 (0%)	18 of 40 (45%)	0 of 40
Vehicle	0 of 40 (0%)	1 of 40 (2.5%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Clinical Trials at LEO PharmaLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Acne Vulgaris

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hala Koudsi, MD principal investigator

Torrance Clinical Research Institute Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LEO43204 in people with Acne Vulgaris, run by LEO Pharma at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Lesion Count (Inflammatory and Non-inflammatory) (time frame: At Week 12 (Day 84)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02575950.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.