AcnePhase 2NCT03034460

Efficacy and Safety of CD5024 1% in Acne Vulgaris

A Phase 2 study testing CD5024 1% cream and CD0271/CD1579 gel in people with Acne, run by Galderma R&D at 7 sites in 3 countries.

Completed

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

Official record

Search all trials

Trial summary

Exploratory, multi-center, randomised, investigator-blinded, vehicle controlled study using intra-individual comparison involving subjects with acne vulgaris on face to evaluate the efficacy of CD5024 1% cream over a 6-week treatment period compared to its vehicle. Read more about this study

Who is it for?: Ages 18 to 35 years
Conditions the study is for: Acne
What is being tested?: CD5024 1% cream and CD0271/CD1579 gel
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 70 participants
Where: 7 sitesin 3 countries
Study dates: 25 Apr 2016to 2 Nov 2016
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

The subject is a male or a female aged from 18 to 35 years old at screening visit.
The subject has a medical diagnosis of acne vulgaris :
2.1 at least 20 (twenty) inflammatory lesions and a maximum of 100 (one hundred) non-inflammatory lesions (nose is excluded for the lesion count) at Baseline
2.2 symmetry of the lesions: No more than twice as many acne lesions on one side as compared to the other side at Baseline
If the subject is a female of childbearing potential, she must agree to use an effective contraceptive method for the duration of the study

Who cannot join

The subject has an underlying known disease surgical or medical condition, in the opinion of the investigator might interfere with interpretation of the study results or put the subject at risk (e.g., other dermatological diseases affecting the treatment area, such as a dermatitis, eczema, etc., or any uncontrolled chronic or serious diseases which would normally prevent participation in any clinical study, such as a cancer, leukemia or severe hepatic impairment), (Screening).
The subject has acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.
The subject has a known or suspected allergies or sensitivities to any components of any of the study drugs (see Investigator's Brochure/Product label).
The subject is a male with beard or facial hair, which would interfere with clinical evaluation or clinical procedure (Screening and Baseline).

Trial locations and contacts

7 sites in 3 countries.

Country

City, postcode or hospital

7 sites in 3 countries

Germany3 sites

Galderma investigational site
Berlin
Galderma investigational site
Bochum
Galderma investigational site
Münster

Other trials in Germany

Canada2 sites

Galderma Investigational site
Montreal, Quebec
Galderma Investigational Site (# 8060)
Windsor, Ontario, N8W 5L7

Other trials in Canada

France2 sites

Galderma investigational site
Nantes
Galderma investigational site
Nice

Other trials in France

About this study

Read the detailed description

Study drugs application will be performed once daily, 5 days a week during 6 weeks

Conditions: Acne
Being tested: CD5024 1% cream, CD5024 cream placebo, CD0271/CD1579 gel, CD0271/CD1579 gel 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.

CD5024 1% creamDrug
500 µL on half-face, five days a week during 6 weeks
CD5024 cream placeboDrug
500 µL on half-face, five days a week during 6 weeks
CD0271/CD1579 gelDrug
500 µL on half-face, five days a week during 6 weeks
CD0271/CD1579 gel placeboDrug
500 µL on half-face, five days a week during 6 weeks

Study groups in NCT03034460
Study group	Role	What they receive
CD5024 1% cream	Experimental	Active drug; Receives: Drug: CD5024 1% cream
CD5024 cream placebo	Placebo comparator	Placebo of active drug; Receives: Drug: CD5024 cream placebo
CD0271/CD1579 gel	Other	Positive control; Receives: Drug: CD0271/CD1579 gel
CD0271/CD1579 gel placebo	Other	Placebo of positive control; Receives: Drug: CD0271/CD1579 gel placebo

What is being measured

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

Inflammatory Lesion Count (Papules and Pustules) at Day 40
Inflammatory lesion count corresponded to the sum of papules and pustules.
Measured: Day 40

Secondary outcomes (10)

Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1)
Inflammatory lesion count corresponded to the sum of papules and pustules.
Measured: Baseline (Day 1)
Percent Reduction From Baseline (Day 1) in Inflammatory Lesion Count at Day 40
Inflammatory lesion count corresponded to the sum of papules and pustules.
Measured: Baseline (Day 1), and Day 40
Total Lesion Count at Baseline (Day 1) and Day 40
Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules.
Measured: Baseline (Day 1), and Day 40
Percent Reduction From Baseline (Day 1) in Total Lesions at Day 40
Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules.
Measured: Baseline (Day 1), and Day 40
Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40
Non-inflammatory lesion counts corresponded to the sum of open and closed comedones.
Measured: Baseline (Day 1), and Day 40
Percent Reduction From Baseline in Non-Inflammatory Lesion at Day 40
Non-inflammatory lesion counts corresponded to the sum of open and closed comedones.
Measured: Baseline (Day 1), and Day 40
Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40
The Investigator gave opinion on their preference after comparison of the left and right sides of the face using the 5-point scale ranging from -2 to 2. The score and description indicated as follows: -2= left side of the face much better than right side, -1= left side of the face better than right side, 0= no clinical difference between the right and left sides of the face, 1= right side of the face better than the left side, 2= right side of the face much better than the left side.
Measured: Day 40
Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40
The participants gave opinion on their preference after comparison of the left and right sides of the face using the 5-point scale ranging from -2 to 2. The score and description indicated as follows: -2= left side of the face much better than right side, -1= left side of the face better than right side, 0= no clinical difference between the right and left sides of the face, 1= right side of the face better than the left side, 2= right side of the face much better than the left side.
Measured: Day 40
Number of Participants With Adverse Events (AEs)
AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: From start of study up to follow up (Week 7)
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7)
Signs and symptoms of local cutaneous irritation(local tolerability [erythema, scaling, dryness, stinging/burning, pruritus]) were evaluated on all treated areas (face and behind ears if applicable) every day from Day 1 up to follow-up (Week 7) using a 4-point scale of None (0), Mild (1), Moderate (2), or Severe (3). Number of participants reported worst local tolerability score on treated areas from Day 1 to follow up (Week 7) was reported.
Measured: From Day 1 up Follow up (Week 7)

Timeline

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

25 Apr 20162 Nov 2016

First posted27 Jan 2017 (estimated)
Study start25 Apr 2016
Primary completion2 Nov 2016
Study completion2 Nov 2016

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 AcneStudies of the same condition, open and under way.
More trials run by Galderma R&DThe sponsor's other registered studies.
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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03034460
Sponsor's protocol ID: RD.03.SPR.109807
Status last verified: Jan 2017
First submitted: 21 Nov 2016
Last updated: 11 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal

All Acne trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of CD5024 1% in Acne Vulgaris
ClinicalTrials.gov ID: NCT03034460
Acronym / sponsor ID: RD.03.SPR.109807
Conditions: Acne
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: 25 Apr 2016 (actual)
Primary completion: 2 Nov 2016 (actual)
Study completion: 2 Nov 2016 (actual)
First posted: 27 Jan 2017 (estimated)
Results: Posted 11 Dec 2020

Clinical summary

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

Detailed description

Study drugs application will be performed once daily, 5 days a week during 6 weeks

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 4

Arm	Type	Receives
CD5024 1% cream	Experimental	Drug: CD5024 1% creamActive drug;
CD5024 cream placebo	Placebo comparator	Drug: CD5024 cream placeboPlacebo of active drug;
CD0271/CD1579 gel	Other	Drug: CD0271/CD1579 gelPositive control;
CD0271/CD1579 gel placebo	Other	Drug: CD0271/CD1579 gel placeboPlacebo of positive control;

Who may qualify

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

Key inclusion criteria (5 listed)

The subject is a male or a female aged from 18 to 35 years old at screening visit.
The subject has a medical diagnosis of acne vulgaris :
2.1 at least 20 (twenty) inflammatory lesions and a maximum of 100 (one hundred) non-inflammatory lesions (nose is excluded for the lesion count) at Baseline
2.2 symmetry of the lesions: No more than twice as many acne lesions on one side as compared to the other side at Baseline
If the subject is a female of childbearing potential, she must agree to use an effective contraceptive method for the duration of the study

Key exclusion criteria (4 listed)

The subject has an underlying known disease surgical or medical condition, in the opinion of the investigator might interfere with interpretation of the study results or put the subject at risk (e.g., other dermatological diseases affecting the treatment area, such as a dermatitis, eczema, etc., or any uncontrolled chronic or serious diseases which would normally prevent participation in any clinical study, such as a cancer, leukemia or severe hepatic impairment), (Screening).
The subject has acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.
The subject has a known or suspected allergies or sensitivities to any components of any of the study drugs (see Investigator's Brochure/Product label).
The subject is a male with beard or facial hair, which would interfere with clinical evaluation or clinical procedure (Screening and Baseline).

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
CD5024 1% cream500 µL on half-face, five days a week during 6 weeks	Drug	CD5024 1% cream
CD5024 cream placebo500 µL on half-face, five days a week during 6 weeks	Drug	CD5024 cream placebo
CD0271/CD1579 gel500 µL on half-face, five days a week during 6 weeks	Drug	CD0271/CD1579 gel
CD0271/CD1579 gel placebo500 µL on half-face, five days a week during 6 weeks	Drug	CD0271/CD1579 gel placebo

Primary outcome

Inflammatory Lesion Count (Papules and Pustules) at Day 40
Time frame: Day 40
Inflammatory lesion count corresponded to the sum of papules and pustules.

10 secondary outcomes

Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1)
Time frame: Baseline (Day 1)
Percent Reduction From Baseline (Day 1) in Inflammatory Lesion Count at Day 40
Time frame: Baseline (Day 1), and Day 40
Total Lesion Count at Baseline (Day 1) and Day 40
Time frame: Baseline (Day 1), and Day 40
Percent Reduction From Baseline (Day 1) in Total Lesions at Day 40
Time frame: Baseline (Day 1), and Day 40
Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40
Time frame: Baseline (Day 1), and Day 40
Percent Reduction From Baseline in Non-Inflammatory Lesion at Day 40
Time frame: Baseline (Day 1), and Day 40
Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40
Time frame: Day 40
Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40
Time frame: Day 40
Number of Participants With Adverse Events (AEs)
Time frame: From start of study up to follow up (Week 7)
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7)
Time frame: From Day 1 up Follow up (Week 7)

Results and safety

Results posted to the registry on 11 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group I: CD5024 Cream Versus Its Vehicle	48	45
Group II: Epiduo Gel Versus Its Vehicle	22	19

Primary outcome: Inflammatory Lesion Count (Papules and Pustules) at Day 40

Time frame: Day 40. Mean (Standard Deviation). Unit: lesion count

Measure	CD5024 1% Cream n = 48	CD5024 1% Cream Matched Placebo n = 48	Adapalene Benzoyl Peroxyde n = 22	Adapalene Benzoyl Peroxyde Matched Placebo n = 22
Value	10.1 (5.8)	8.9 (5.0)	6.1 (4.9)	9.4 (5.7)

CD5024 1% Cream vs CD5024 1% Cream Matched Placebo: p = 0.158, Wilcoxon rank signed test
Adapalene Benzoyl Peroxyde vs Adapalene Benzoyl Peroxyde Matched Placebo: p = 0.002, Wilcoxon rank signed test

Population analysed: This analysis was performed on ITT- last observation carried forward (LOCF) population. ITT-population included all participants who were randomized. Outcome measure data was summarized using the LOCF at Day 40. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: From start of study up to follow up (Week 7). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group I: CD5024 Cream Versus Its Vehicle	0 of 48 (0%)	32 of 48 (66.7%)	0 of 48
Group II: Epiduo Gel Versus Its Vehicle	0 of 22 (0%)	11 of 22 (50%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acne

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
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RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
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RecruitingPhase 3
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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.

The record lists no contact. Use the official record to reach the sponsor.

7 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CD5024 1% cream and CD0271/CD1579 gel in people with Acne, run by Galderma R&D at 7 sites in 3 countries.

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 5 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 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany, Canada, France. 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 11 Dec 2020). 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?

Inflammatory Lesion Count (Papules and Pustules) at Day 40 (time frame: Day 40). 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 NCT03034460.

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 11 Dec 2020.