Acne VulgarisPhase 3NCT00446043

Long-term Study of Efficacy/Safety of Adapalene/Benzoyl Peroxide Topical Gel in Acne Vulgaris Subjects

A Phase 3 study testing Adapalene/Benzoyl Peroxide in people with Acne Vulgaris, run by Galderma R&D at 1 site in United States.

Completed

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

Official record

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Trial summary

This was a multi-center, open-label, non-comparative study that evaluated the long-term safety and efficacy profile of Adapalene/Benzoyl Peroxide Gel. Subjects were evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Acne Vulgaris
What is being tested?: Adapalene/Benzoyl Peroxide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 452 participants
Where: 1 siteUnited States
Study dates: 17 Feb 2004to 23 May 2005
Phase: Phase 3
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 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

A clinical diagnosis of acne vulgaris with facial involvement.
A minimum of 20 but not more than 50 Inflammatory lesions.
A minimum of 30 but not more than 100 Noninflammatory lesions.

Who cannot join

Subjects with presence of nodules or cysts.
Acne conglobate, acne fulminans, secondary acne, or severe acne.
Underlying diseases that required the use of interfering topical or systemic therapy.
Use of prohibited medications prior to the study unless appropriate washout period was documented.

Trial locations and contacts

1 site in 1 country.

United States1 site

Phoebe Rich, MD
Portland, Oregon, 97210

Other trials in United States

About this study

Official title: A Long-term Safety and Efficacy Study of a Fixed Combination of Adapalene 0.1% and Benzoyl Peroxide 2.5% (Adapalene and Benzoyl Peroxide Topical Gel) Gel in Subjects With Acne Vulgaris

This was a multi-center, open-label, non-comparative study that evaluated the long-term safety and efficacy profile of Adapalene/Benzoyl Peroxide Gel.

Subjects were evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12.

Safety was evaluated by spontaneous reports of Adverse Events (AEs), the Local Tolerability Assessment (Erythema, Scaling, Dryness, and Stinging/Burning), routine laboratory testing (hematology, blood chemistry, and urinalysis), and monitoring of suspected sensitizations. Efficacy was evaluated by analysis of Percent Change from Baseline in Inflammatory, Noninflammatory, and Total Lesion Counts, and by the Subject's Assessment of Acne.

Conditions: Acne Vulgaris
Being tested: Adapalene/Benzoyl Peroxide
Keywords: Acne Vulgaris, Adapalene, Benzoyl Peroxide
Medical subject headings: Acne Vulgaris

What participants receive

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

Adapalene/Benzoyl PeroxideDrug
Adapalene 0.1 percent (%) [weight by weight (W/W)] and benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening.

Study groups in NCT00446043
Study group	Role	What they receive
Adapalene/Benzoyl Peroxide	Experimental	Participants were treated with adapalene 0.1 percent (%) [weight by weight (W/W)] and benzoyl peroxide 2.5 percent (%) (W/W) gel topically to the face and trunk area once daily in the evening. Receives: Drug: Adapalene/Benzoyl Peroxide

What is being measured

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

Percent Change From Baseline in Inflammatory, Noninflammatory and Total Lesion Count at Month 12 LOCF
Percent change in inflammatory, noninflammatory and total lesions at Month 12 was measured from baseline lesions. The noninflammatory lesion count was the sum of open comedones (a mass of sebaceous material that is impacted behind an open follicular orifice (blackhead) and closed comedones (a mass of sebaceous material that is impacted behind a closed follicular orifice (whitehead). The inflammatory lesion count was the sum of papules (a small, solid elevation less than 1.0 cm in diameter) and pustules (a small, circumscribed elevation of the skin that contains yellow-white exudate). The total lesion count was the sum of inflammatory and noninflammatory lesions. Missing adapalene and benzoyl peroxide data were imputed using last observation carried forward (LOCF).
Measured: Baseline, Month 12 LOCF
Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 6
Participant's assessment of acne improvement was graded as 0; complete improvement, 1; marked improvement, 2; moderate improvement, 3; minimal improvement, 4; no change, 5; worse.
Measured: At Month 6
Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 12
Participant's assessment of acne improvement was graded as 0; complete improvement, 1; marked improvement, 2; moderate improvement, 3; minimal improvement, 4; no change, 5; worse.
Measured: At Month 12

Secondary outcomes (6)

Number of Participants With Local Tolerability Assessment For Erythema
Local tolerability assessment for erythema (abnormal redness of the skin) was graded on a "0" (none) to "3" (severe) scale as follows; none (0- no erythema), mild (1- slight pinkness present), moderate (2- definite redness, easily recognized), severe (3- intense redness). The worst severity scores were generally mild or moderate, and rarely severe.
Measured: Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12
Number of Participants With Local Tolerability Assessment For Scaling
Local tolerability assessment for scaling (abnormal shedding of the stratum corneum) was graded on a "0" (none) to "3" (severe) scale as follow; none (0- no Scaling), mild (1- barely perceptible shedding, noticeable only on light scratching or rubbing), moderate (2- obvious but not profuse shedding), severe (3- heavy scale production).
Measured: Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12
Number of Participants With Local Tolerability Assessment For Dryness
Local tolerability assessment for dryness (brittle and/or tight sensation) was graded on a "0" (none) to "3" (severe) scale as follows; none (0- no dryness), mild (1- slight but definite roughness), moderate (2 -moderate roughness), severe (3- marked roughness).
Measured: Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Local tolerability assessment for stinging/burning [prickling pain sensation immediately after (within 5 minutes of) dosing] was graded on a "0" (none) to "3" (severe) scale as follows; none (0- no stinging/ burning), mild (1- slight warm, tingling/stinging sensation; not really bothersome), moderate (2- definite warm, tingling/stinging sensation that is somewhat), severe (3- hot, tingling/stinging sensation that has caused definite discomfort).
Measured: Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12
Number of Participant With Adverse Event (AE) and Serious Adverse Event (SAE)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Baseline up to Month 14
Number of Participants With Clinically Significant Abnormal Laboratory Parameters
Clinical laboratory parameters included hematology, blood chemistry, urinalysis. Number of participants with clinically significant abnormalities in laboratory parameters which were deemed clinically significant by the investigator were reported.
Measured: Baseline up to Month 14

Timeline

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

17 Feb 200423 May 2005

First posted12 Mar 2007 (estimated)
Study start17 Feb 2004
Primary completion23 May 2005
Study completion23 May 2005

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acne VulgarisStudies 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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 452 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00446043
Sponsor's protocol ID: RD.06.SPR.18089
Status last verified: Aug 2022
First submitted: 8 Mar 2007
Last updated: 11 Jul 2023
Results posted: Yes, on ClinicalTrials.gov

Publications

Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol. 2003 Sep;49(3 Suppl):S200-10. doi: 10.1067/s0190-9622(03)01154-x.
PubMed 12963896

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 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Long-term Safety and Efficacy Study of a Fixed Combination of Adapalene 0.1% and Benzoyl Peroxide 2.5% (Adapalene and Benzoyl Peroxide Topical Gel) Gel in Subjects With Acne Vulgaris
ClinicalTrials.gov ID: NCT00446043
Acronym / sponsor ID: RD.06.SPR.18089
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris, Adapalene, Benzoyl Peroxide
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 452 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: 17 Feb 2004 (actual)
Primary completion: 23 May 2005 (actual)
Study completion: 23 May 2005 (actual)
First posted: 12 Mar 2007 (estimated)
Results: Posted 11 Jul 2023

Clinical summary

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

This was a multi-center, open-label, non-comparative study that evaluated the long-term safety and efficacy profile of Adapalene/Benzoyl Peroxide Gel.

Subjects were evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Adapalene/Benzoyl Peroxide	Experimental	Drug: Adapalene/Benzoyl PeroxideParticipants were treated with adapalene 0.1 percent (%) [weight by weight (W/W)] and benzoyl peroxide 2.5 percent (%) (W/W) gel topically to the face and trunk area once daily in the evening.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

A clinical diagnosis of acne vulgaris with facial involvement.
A minimum of 20 but not more than 50 Inflammatory lesions.
A minimum of 30 but not more than 100 Noninflammatory lesions.

Key exclusion criteria (4 listed)

Subjects with presence of nodules or cysts.
Acne conglobate, acne fulminans, secondary acne, or severe acne.
Underlying diseases that required the use of interfering topical or systemic therapy.
Use of prohibited medications prior to the study unless appropriate washout period was documented.

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
Adapalene/Benzoyl PeroxideAdapalene 0.1 percent (%) [weight by weight (W/W)] and benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening.	Drug	Adapalene/Benzoyl Peroxide

Primary outcome

Percent Change From Baseline in Inflammatory, Noninflammatory and Total Lesion Count at Month 12 LOCF
Time frame: Baseline, Month 12 LOCF
Percent change in inflammatory, noninflammatory and total lesions at Month 12 was measured from baseline lesions. The noninflammatory lesion count was the sum of open comedones (a mass of sebaceous material that is impacted behind an open follicular orifice (blackhead) and closed comedones (a mass of sebaceous material that is impacted behind a closed follicular orifice (whitehead). The inflammatory lesion count was the sum of papules (a small, solid elevation less than 1.0 cm in diameter) and pustules (a small, circumscribed elevation of the skin that contains yellow-white exudate). The total lesion count was the sum of inflammatory and noninflammatory lesions. Missing adapalene and benzoyl peroxide data were imputed using last observation carried forward (LOCF).
Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 6
Time frame: At Month 6
Participant's assessment of acne improvement was graded as 0; complete improvement, 1; marked improvement, 2; moderate improvement, 3; minimal improvement, 4; no change, 5; worse.
Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 12
Time frame: At Month 12
Participant's assessment of acne improvement was graded as 0; complete improvement, 1; marked improvement, 2; moderate improvement, 3; minimal improvement, 4; no change, 5; worse.

6 secondary outcomes

Number of Participants With Local Tolerability Assessment For Erythema
Time frame: Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12
Number of Participants With Local Tolerability Assessment For Scaling
Time frame: Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12
Number of Participants With Local Tolerability Assessment For Dryness
Time frame: Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Time frame: Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12
Number of Participant With Adverse Event (AE) and Serious Adverse Event (SAE)
Time frame: Baseline up to Month 14
Number of Participants With Clinically Significant Abnormal Laboratory Parameters
Time frame: Baseline up to Month 14

Results and safety

Results posted to the registry on 11 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adapalene/Benzoyl Peroxide	452	327

Primary outcome: Percent Change From Baseline in Inflammatory, Noninflammatory and Total Lesion Count at Month 12 LOCF

Time frame: Baseline, Month 12 LOCF. Mean (Standard Deviation). Unit: percent change

Measure	Adapalene/Benzoyl Peroxide n = 452
Inflammatory Lesion Counts	-59.70 (34.268)
Noninflammatory Lesion Counts	-58.80 (33.206)
Total Lesion Counts	-58.85 (29.273)

Population analysed: ITT population included all participants who were enrolled and treated to whom medication was dispensed.

Primary outcome: Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 6

Time frame: At Month 6. Count of participants. Unit: Participants

Measure	Adapalene/Benzoyl Peroxide n = 359
0=Complete Improvement	17
1=Marked Improvement	149
2=Moderate Improvement	147
3=Minimal Improvement	31
4=No Change	11
5=Worse	4

Population analysed: ITT population included all participants who were enrolled and to whom medication was dispensed. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Primary outcome: Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 12

Time frame: At Month 12. Count of participants. Unit: Participants

Measure	Adapalene/Benzoyl Peroxide n = 327
0=Complete Improvement	40
1=Marked Improvement	164
2=Moderate Improvement	77
3=Minimal Improvement	37
4=No Change	6
5=Worse	3

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 14 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adapalene/Benzoyl Peroxide	5 of 452 (1.1%)	288 of 452 (63.7%)	0 of 452

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12963896Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol. 2003 Sep;49(3 Suppl):S200-10. doi: 10.1067/s0190-9622(03)01154-x.

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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.

Michael Graeber, MD study director

Galderma R&D

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adapalene/Benzoyl Peroxide in people with Acne Vulgaris, run by Galderma R&D 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 3 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 Jul 2023. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Jul 2023). 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?

Percent Change From Baseline in Inflammatory, Noninflammatory and Total Lesion Count at Month 12 LOCF (time frame: Baseline, Month 12 LOCF). The study lists 3 primary outcomes in all. 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 NCT00446043, which also lists 1 linked publication.

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 Jul 2023.