Acne VulgarisPhase 1NCT01742637
Study Comparing Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% to Epiduo® and Both to a Placebo Control in the Treatment of Acne Vulgaris
A Phase 1 study testing Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% and Epiduo® Gel in people with Acne Vulgaris, run by Sun Pharmaceutical Industries, Inc..
Trial summary
The objective of this study is to evaluate the therapeutic equivalence and safety of Adapalene and Benzoyl Peroxide 0.1%/2.5% Gel (Taro Pharmaceuticals Inc.) and Epiduo® (Adapalene and Benzoyl Peroxide 0.1%/2.5% Gel) (Galderma Laboratories, L.P.) in the treatment of acne vulgaris, and to demonstrate the superiority of… Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% and Epiduo® Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,008 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Mar 2014
- Phase
- Phase 1
- 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 12 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
- Subjects who are 18 years of age or older must have provided written informed consent. Subjects 12 to 17 years of age must have provided written assent, which must be accompanied by written informed consent from the subject's legally acceptable representative. All subjects or their legally acceptable representatives must sign a Health Insurance Portability and Accountability Act authorization.
- Subjects must have a minimum of ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions, at baseline on the face.
- Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA).
- Subjects must be willing to refrain from using all other topical acne medications or antibiotics for acne vulgaris during the 12-week treatment period, other than the investigational product.
- Female subjects of childbearing potential (excluding those who are surgically sterilized or postmenopausal for at least 1 year), in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study from the day of the first dose administration to 30 days after the last administration of study drug.
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- All male subjects must agree to use accepted methods of birth control with their partners, from the day of the first dose administration to 30 days after the last administration of study drug.
- Subjects must be willing and able to understand and comply with the requirements of the protocol.
- Subjects must be in good health and free from any clinically significant disease, including but not limited to, conditions that may interfere with the evaluation of acne vulgaris.
- Subjects who use make-up must have used the same brands/types for a minimum period of 14 days prior to study entry and must agree to not change brand/type or frequency of use throughout the study.
Who cannot join
- Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
- Subjects with a history of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients, have a known hypersensitivity to adapalene and benzoyl peroxide and its excipients.
- Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris.
- Subjects with excessive facial hair that would interfere with diagnosis or assessment of acne vulgaris.
- Subjects who have performed wax depilation of the face within 14 days prior to baseline.
- Subjects who have used within 6 months prior to baseline or use during the study of oral retinoids or therapeutic Vitamin A supplements of greater than 10,000 units/day.
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- Subjects who have used estrogens or oral contraceptives for less than 3 months prior to baseline.
- Subjects who have used any of the following procedures on the face within 1 month prior to baseline or use during the study: cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, intralesional steroids, x-ray therapy.
- Subjects who have used any of the following treatments within 1 month prior to baseline or use during the study: systemic steroids, systemic antibiotics, systemic treatment for acne vulgaris, systemic anti-inflammatory agents.
- Subjects who have used any of the following treatments within 2 weeks prior to baseline or during the study: topical steroids, topical retinoids, α-hydroxy/glycolic acid, benzoyl peroxide, topical anti-inflammatory agents, topical antibiotics.
- Use of spironolactone is prohibited during the study.
- Use of tanning booths, sunbathing, or excessive exposure to the sun are prohibited during the study.
- Subjects who have received radiation therapy and/or anti-neoplastic agents within 90 days prior to baseline.
- Subjects who have unstable medical disorders that are clinically significant or have life-threatening diseases.
- Subjects who have on-going malignancies requiring systemic treatment, and subjects who have any malignancy of the skin of the facial area.
- Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold.
- Subjects who consume excessive amounts of alcohol or use drugs of abuse.
- Subjects who have participated in an investigational drug study within 30 days prior to baseline.
- Subjects who have been previously enrolled in this study.
- Subjects who have had laser therapy, electrodesiccation and phototherapy to the facial area within 180 days prior to study entry.
- Subjects who have had cosmetic procedures which may affect the efficacy and safety profile of the investigational product within 14 days prior to study entry. Cosmetic procedures and facials are prohibited throughout the study.
- Subjects who currently have or have recently had bacterial folliculitis on the face.
About this study
Official title: A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study Comparing Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% (Taro Pharmaceuticals Inc.) to Epiduo® (Galderma Laboratories, L.P., Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%) and Both Active Treatments to a Placebo in the Treatment of Acne Vulgaris.
The objective of this study is to evaluate the therapeutic equivalence and safety of Adapalene and Benzoyl Peroxide 0.1%/2.5% Gel (Taro Pharmaceuticals Inc.) and Epiduo® (Adapalene and Benzoyl Peroxide 0.1%/2.5% Gel) (Galderma Laboratories, L.P.) in the treatment of acne vulgaris, and to demonstrate the superiority of the efficacy of the test and reference products over the vehicle (placebo) control in the treatment of acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%, Epiduo® Gel, Placebo
- Keywords
- Acne Vulgaris, Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%, Epiduo®
- 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 and Benzoyl Peroxide Gel 0.1%/2.5%Drug
Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% (Taro Pharmaceuticals Inc.)applied topically once daily for 84 consecutive days.
Epiduo® GelDrug
Epiduo® (Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%) (Galderma Laboratories, L.P.)applied topically once daily for 84 consecutive days.
PlaceboDrug
Placebo (vehicle of test product) (Taro Pharmaceuticals Inc.)applied topically once daily for 84 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% | Experimental | Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% (Taro Pharmaceuticals Inc.) Receives: Drug: Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% |
| Epiduo® Gel | Active comparator | Epiduo® (Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%) (Galderma Laboratories, L.P.) Receives: Drug: Epiduo® Gel |
| Placebo | Placebo comparator | Placebo (vehicle of test product) (Taro Pharmaceuticals Inc.) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory and non-inflammatory lesion counts
Percent change from baseline to week 12 in the inflammatory (papules and pustules) and non-inflammatory (open and closed comedones) lesion counts.
Measured: Week 12
Secondary outcomes (1)
Clinical response of success.
The proportion of subjects with a clinical response (IGA) of success at week 12. Success should be defined as an IGA score that is at least 2 grades less than the baseline assessment.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionFeb 2014
- Study completionMar 2014
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,008 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Catawba Research, Study chair, http://catawbaresearch.com/contact/
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742637
- Sponsor's protocol ID
- ADBG-1206, 1302
- Status last verified
- May 2017
- First submitted
- 3 Dec 2012
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study Comparing Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% (Taro Pharmaceuticals Inc.) to Epiduo® (Galderma Laboratories, L.P., Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%) and Both Active Treatments to a Placebo in the Treatment of Acne Vulgaris.
- ClinicalTrials.gov ID
- NCT01742637
- Acronym / sponsor ID
- ADBG-1206, 1302
- Conditions
- Acne Vulgaris
- Keywords
- Acne Vulgaris, Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%, Epiduo®
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,008 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 5 Dec 2012 (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.
The objective of this study is to evaluate the therapeutic equivalence and safety of Adapalene and Benzoyl Peroxide 0.1%/2.5% Gel (Taro Pharmaceuticals Inc.) and Epiduo® (Adapalene and Benzoyl Peroxide 0.1%/2.5% Gel) (Galderma Laboratories, L.P.) in the treatment of acne vulgaris, and to demonstrate the superiority of the efficacy of the test and reference products over the vehicle (placebo) control in the treatment of acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% | Experimental | Drug: Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% (Taro Pharmaceuticals Inc.) |
| Epiduo® Gel | Active comparator | Drug: Epiduo® GelEpiduo® (Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%) (Galderma Laboratories, L.P.) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (vehicle of test product) (Taro Pharmaceuticals Inc.) |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
- Subjects who are 18 years of age or older must have provided written informed consent. Subjects 12 to 17 years of age must have provided written assent, which must be accompanied by written informed consent from the subject's legally acceptable representative. All subjects or their legally acceptable representatives must sign a Health Insurance Portability and Accountability Act authorization.
- Subjects must have a minimum of ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions, at baseline on the face.
- Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA).
- Subjects must be willing to refrain from using all other topical acne medications or antibiotics for acne vulgaris during the 12-week treatment period, other than the investigational product.
Key exclusion criteria (22 listed)
- Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
- Subjects with a history of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients, have a known hypersensitivity to adapalene and benzoyl peroxide and its excipients.
- Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris.
- Subjects with excessive facial hair that would interfere with diagnosis or assessment of acne vulgaris.
- Subjects who have performed wax depilation of the face within 14 days prior to 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 |
|---|---|---|
| Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% (Taro Pharmaceuticals Inc.)applied topically once daily for 84 consecutive days. | Drug | Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% |
| Epiduo® GelEpiduo® (Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%) (Galderma Laboratories, L.P.)applied topically once daily for 84 consecutive days. | Drug | Epiduo® Gel |
| PlaceboPlacebo (vehicle of test product) (Taro Pharmaceuticals Inc.)applied topically once daily for 84 consecutive days. | Drug | Placebo |
Primary outcome
Inflammatory and non-inflammatory lesion counts
Time frame: Week 12
Percent change from baseline to week 12 in the inflammatory (papules and pustules) and non-inflammatory (open and closed comedones) lesion counts.
1 secondary outcome
Clinical response of success.
Time frame: Week 12
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 4 May 2017.
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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.
Catawba Research study chair
http://catawbaresearch.com/contact/
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% and Epiduo® Gel in people with Acne Vulgaris, run by Sun Pharmaceutical Industries, Inc..
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 10 inclusion and 22 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 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Inflammatory and non-inflammatory lesion counts (time frame: Week 12). 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 4 May 2017.