Acne VulgarisNCT00624676
Efficacy and Tolerance of a Derivative of Salicylic Acid and 5% Benzoyl Peroxide in Facial Acne Vulgaris
A study testing Lipo Hydroxy Acid and 5% benzoyl peroxide gel in people with Acne Vulgaris, run by Cosmetique Active International at 2 sites in Canada.
Trial summary
Acne vulgaris is a frequent inflammatory skin condition involving the pilosebaceous unit and affecting more than 80% of teenagers. Mild to moderate acne vulgaris is usually treated with topical agents such as benzoyl peroxide, retinoids and antibiotics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Lipo Hydroxy Acid and 5% benzoyl peroxide gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2006to Aug 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or older
- Phototype greater than I
- Facial inflammatory acne with 15-50 inflammatory lesions and less than 50 non-inflammatory lesions (excluding the nasal pyramid)
- Did not receive a topical acne treatment in the last 15 days
- Did not receive cyclins or zinc-based treatment in the last month
- Did not take Diane-35 in the last 2 months. Current use of oral contraceptives is acceptable if the subject is on a stable dose for at least six months prior Day 0.
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- Did not take oral isotretinoin for the last 12 months
- Did not change their cosmetic habits in the last 15 days (ex: shaving cream)
- Agree to participate to the entire study
Who cannot join
- Less than 18 years old
- Phototype I
- With less than 15 or more than 50 inflammatory lesions on the face (excluding the nasal pyramid)
- With more than 50 non-inflammatory lesions on the face (excluding the nasal pyramid)
- Have taken 1) A topical acne treatment in the last 15 days, or 2) Cyclins or zinc-based treatment in the last month or 3) Oral isotretinoin in the last 12 months
- Woman: 1) Taking Diane-35, or 2) Taking an oral contraceptive for less than 6 months or 3) That are pregnant or 4) That are nursing or 5) Not using any efficient contraception method (if necessary)
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- With a history of allergic reaction or hypersensitivity to one of the constituents of the study product
- With peroxide sensitivity
- With history of photosensitivity
- With history of major medical or psychiatric condition or surgical interventions that, in the opinion of the investigator, might put the subject at risk
- With an acute or chronic disease that could interfere with study results
- Susceptible to take a corticosteroid treatment during the study except inhaled or topic when needed to treat a condition outside the face
- With a dermatologic condition on the face other than acne that might put the subject at risk or interfere with study evaluations
- Using another cosmetic product than the one received for this study. Sunscreens are allowed occasionally.
- Subject who must have extensive sun or ultra-violet exposure
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Innovaderm Research
Laval, Quebec
Innovaderm Research
Montreal, Quebec
About this study
Official title: Randomized Study Comparing the Efficacy and Tolerance of a Lipophilic Hydroxy Acid Derivative of Salicylic Acid and 5% Benzoyl Peroxide in the Treatment of Facial Acne Vulgaris
Acne vulgaris is a frequent inflammatory skin condition involving the pilosebaceous unit and affecting more than 80% of teenagers. Mild to moderate acne vulgaris is usually treated with topical agents such as benzoyl peroxide, retinoids and antibiotics. These treatments can be associated with local tolerance problems and/or antibiotic resistance. Salicylic acid has been shown to be an effective treatment for acne. LHA is a lipophilic hydroxy acid derivative of salicylic acid that has comedolytic and antibacterial properties.
The objective of this trial was to compare the efficacy and tolerance of a cream formulation containing 0.3% LHA (LHA formulation) to a 5% benzoyl peroxide gel.
Read the detailed description
This was a randomized clinical trial performed at two centers (Montreal and Laval, Quebec, Canada) under the direction of the same principal investigator. Eighty (80) subjects were enrolled in the study. Subjects were asked to report to the clinic for four visits (D0, D28, D56, D87). The LHA formulation was applied twice a day (morning and evening) and benzoyl peroxide was applied daily (evening) on a clean face for a total of 12 weeks.
Efficacy was evaluated at day 28, 56 and 87. The number of papules, pustules, opened and closed comedones were counted at each visit by a blinded assessor. The overall efficacy was evaluated with a 4-point scale (no improvement, moderate, good and excellent) by the subject and the blinded assessor. Clinical examination included evaluation of sensitivity of the skin (presence of erythema and desquamation) by the investigator and of pruritus, tingling and burning sensation by subjects on a 4-point scale. Finally, the subject and the skin assessor both evaluated overall tolerance on a 4-point scale.
- Conditions
- Acne Vulgaris
- Being tested
- Lipo Hydroxy Acid, 5% benzoyl peroxide gel
- Keywords
- Acne, lipophilic hydroxy acid, 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.
Lipo Hydroxy AcidDrug
Also called Effaclar AI, 2-hydroxy 5-octanoyl benzoic acid, LHA, C8-LHA
Twice a day
5% benzoyl peroxide gelDrug
Also called PanOxyl 5
Once a day
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | LHA formulation Receives: Drug: Lipo Hydroxy Acid |
| B | Active comparator | 5% benzoyl peroxide Receives: Drug: 5% benzoyl peroxide gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in inflammatory lesions
Measured: Days 28, 56 and 87
Secondary outcomes (5)
Reduction in non-inflammatory lesions
Measured: Days 28, 56 and 87
Overall efficacy
Measured: Days 28, 56 and 87
Overall tolerance
Measured: Days 28, 56 and 87
Evaluation of pruritus, burning and tingling by the subject
Measured: Days 28, 56 and 87
Evaluation of erythema and desquamation by the blind assessor
Measured: Days 28, 56 and 87
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startJan 2006
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innovaderm Research Inc.
- Responsible party
- Principal investigator, Robert BISSONNETTE, Cosmetique Active International
- Investigators
- Robert Bissonnette, MD, Principal investigator, Innovaderm Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624676
- Sponsor's protocol ID
- LRP05021
- Status last verified
- Sep 2011
- First submitted
- 19 Feb 2008
- Last updated
- 20 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Comparing the Efficacy and Tolerance of a Lipophilic Hydroxy Acid Derivative of Salicylic Acid and 5% Benzoyl Peroxide in the Treatment of Facial Acne Vulgaris
- ClinicalTrials.gov ID
- NCT00624676
- Acronym / sponsor ID
- LRP05021
- Conditions
- Acne Vulgaris
- Keywords
- Acne, lipophilic hydroxy acid, benzoyl peroxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Collaborators
- Innovaderm Research Inc.
- Study start
- Jan 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 27 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acne vulgaris is a frequent inflammatory skin condition involving the pilosebaceous unit and affecting more than 80% of teenagers. Mild to moderate acne vulgaris is usually treated with topical agents such as benzoyl peroxide, retinoids and antibiotics. These treatments can be associated with local tolerance problems and/or antibiotic resistance. Salicylic acid has been shown to be an effective treatment for acne. LHA is a lipophilic hydroxy acid derivative of salicylic acid that has comedolytic and antibacterial properties.
The objective of this trial was to compare the efficacy and tolerance of a cream formulation containing 0.3% LHA (LHA formulation) to a 5% benzoyl peroxide gel.
Detailed description
This was a randomized clinical trial performed at two centers (Montreal and Laval, Quebec, Canada) under the direction of the same principal investigator. Eighty (80) subjects were enrolled in the study. Subjects were asked to report to the clinic for four visits (D0, D28, D56, D87). The LHA formulation was applied twice a day (morning and evening) and benzoyl peroxide was applied daily (evening) on a clean face for a total of 12 weeks.
Efficacy was evaluated at day 28, 56 and 87. The number of papules, pustules, opened and closed comedones were counted at each visit by a blinded assessor. The overall efficacy was evaluated with a 4-point scale (no improvement, moderate, good and excellent) by the subject and the blinded assessor. Clinical examination included evaluation of sensitivity of the skin (presence of erythema and desquamation) by the investigator and of pruritus, tingling and burning sensation by subjects on a 4-point scale. Finally, the subject and the skin assessor both evaluated overall tolerance on a 4-point scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Lipo Hydroxy AcidLHA formulation |
| B | Active comparator | Drug: 5% benzoyl peroxide gel5% benzoyl peroxide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years old or older
- Phototype greater than I
- Facial inflammatory acne with 15-50 inflammatory lesions and less than 50 non-inflammatory lesions (excluding the nasal pyramid)
- Did not receive a topical acne treatment in the last 15 days
- Did not receive cyclins or zinc-based treatment in the last month
Key exclusion criteria (15 listed)
- Less than 18 years old
- Phototype I
- With less than 15 or more than 50 inflammatory lesions on the face (excluding the nasal pyramid)
- With more than 50 non-inflammatory lesions on the face (excluding the nasal pyramid)
- Have taken 1) A topical acne treatment in the last 15 days, or 2) Cyclins or zinc-based treatment in the last month or 3) Oral isotretinoin in the last 12 months
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 |
|---|---|---|
| Lipo Hydroxy AcidAlso: Effaclar AI, 2-hydroxy 5-octanoyl benzoic acid, LHA, C8-LHATwice a day | Drug | A |
| 5% benzoyl peroxide gelAlso: PanOxyl 5Once a day | Drug | B |
Primary outcome
Reduction in inflammatory lesions
Time frame: Days 28, 56 and 87
5 secondary outcomes
Reduction in non-inflammatory lesions
Time frame: Days 28, 56 and 87
Overall efficacy
Time frame: Days 28, 56 and 87
Overall tolerance
Time frame: Days 28, 56 and 87
Evaluation of pruritus, burning and tingling by the subject
Time frame: Days 28, 56 and 87
Evaluation of erythema and desquamation by the blind assessor
Time frame: Days 28, 56 and 87
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2011.
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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.
Robert Bissonnette, MD principal investigator
Innovaderm Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipo Hydroxy Acid and 5% benzoyl peroxide gel in people with Acne Vulgaris, run by Cosmetique Active International at 2 sites in Canada.
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 9 inclusion and 15 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 20 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in inflammatory lesions (time frame: Days 28, 56 and 87). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2011.