Acne VulgarisPhase 1NCT01182636
Bioequivalence of Adapalene Topical Gel in Patients With Acne Vulgaris
A Phase 1 study testing Adapalene and Differin® in people with Acne Vulgaris, run by Teva Pharmaceuticals USA at 22 sites in 2 countries.
Trial summary
The objective of this study was to evaluate the efficacy and safety of the test formulation of adapalene gel 0.1% (PLIVA Research \& Development Ltd.) as compared to the already marketed formulation, Differin® (adapalene 0.1%) topical gel (Galderma Laboratories) in patients with acne vulgaris. 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 Differin®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 601 participants
- Where
- 22 sitesin 2 countries
- Study dates
- Jul 2007to Apr 2008
- 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
- Male or non-pregnant, non-lactating female, 12-40 years of age inclusive.
- Signed informed consent form, which meets all the criteria of the current FDA regulations. For patients under the age of majority in the state they are enrolled, the patient's parent or legal guardian will be required to sign the consent form and the patient will sign an IRB approved "assent to participate" form.
- If female and of child bearing potential, prepare to abstain from sexual intercourse or use reliable method of contraception during the study (i.e. condom, Intrauterine device, hormonal contraceptives). Patients on hormonal contraceptives must have been on the same hormonal contraceptive for 3 months prior to the baseline visit and continue throughout the duration of the study.
- Have moderate to severe facial acne as defines as: at least 20 but no more that 60 facial inflammatory lesions (papules and pustules) and at least 25 but no more than 100 non-inflamed lesions (open and closed comedones) and have a Physician's Global Assessment score of 3, 4, or 5.
Who cannot join
- Patient has more than 2 facial nodular lesions, any nodules present will be documented but will not be included in the inflammatory lesion count.
- Patient has active cystic acne.
- Patient has acne conglobate.
- Patient with significant facial hair such as beards or tattoos or excessive facial scarring that, in the Investigator's opinion, may interfere with the evaluation of the patient's acne.
- Patients with facial sunburn.
- Any dermatological condition other than acne vulgaris that, in the Investigator's opinion, may interfere with the evaluation of the patient's acne (e.g. rosacea, psoriasis, dermatitis).
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- Females who are pregnant, lactating, or likely to become pregnant during the study.
- History of allergy or sensitivity to adapalene or other retinoids, or history of any drug hypersensitivity or intolerance which, in the Investigator's opinion, would compromise the safety of the patient or the study.
- Significant history or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that, in the Investigator's opinion, would place the study participant at undue risk by participation.
- Use of any topical antibiotics, topical steroids, or topical anti-inflammatory products used on the face, any oral antibiotics known to treat acne, any systemic steroids, or any systemic anti-inflammatory agents (other than the use of non-steroidal anti-inflammatory agents) within 28 days of the first dosing day.
- Use of oral isotretinoin (Accutane®) within 6 months. Use of topical tretinoin (Retin-A®), adapalene (Differin®), tazarotene (Tazorac®), or azelaic acid (Azelex®) within 28 days of the first dosing day.
- Receipt of any drug as part of a research study within 30 days prior to dosing.
- Female patients who are using hormonal contraceptives must have been on the same type and strength of hormonal contraceptive for at least 3 months prior to enrollment in the study and throughout the duration of the study.
- Patients should not use any medicated facial products (soaps, lotions, moisturizers, etc.) or other medicated facial cleansing agents for 14 days prior to study enrollment.
- Previous participation in this study.
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States20 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
Arlington Center for Dermatology
Arlington, Texas, 76011
SNBL Clinical Pharmacology Center, Inc.
Baltimore, Maryland, 21201
University Dermatology Consultants, Inc.
Cincinnati, Ohio, 45219
Michigan Center for Research Corportation
Clinton Township, Michigan, 48038
Cherry Creek Research, Inc.
Denver, Colorado, 80209
Office of Zoe Diana Draelos, MD
High Point, North Carolina, 27262
Center for Clinical Studies
Houston, Texas, 77030
Center for Clinical Studies
Houston, Texas, 77058
Knoxville Dermatology, PC
Knoxville, Tennessee, 37920
Office of Atoya Breona Adams, MD
Las Vegas, Nevada, 89119
Dermatology Research of Arkansas
Little Rock, Arkansas, 72205
Dermatology Research Associates
Los Angeles, California, 90045
Aurora Advanced Healthcare, Inc.
Milwaukee, Wisconsin, 53209
MedaPhase, Inc.
Newnan, Georgia, 30263
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024
Novum Pharmaceutical Research Services
Pittsburgh, Pennsylvania, 15206
Helendale Dermatology & Medical Spa, LLC
Rochester, New York, 14609
Dermatology Associates of Rochester, PC
Rochester, New York, 14623
Dermatology Associates of Tyler
Tyler, Texas, 75701
Belize2 sites
Dermatology and Skin Surgery Centre
Belize City
FXM Research International
Belize City
About this study
Official title: A Randomized, Double-Blind, Multiple-Site, Placebo Controlled, Parallel Design, Clinical Study to Evaluate the Bioequivalence of Adapalene Gel 0.1% (PLIVA Research & Development Ltd.) Compared to Differin® (Adapalene 0.1%) Topical Gel (Galderma Laboratories) in Patients With Acne Vulgaris
The objective of this study was to evaluate the efficacy and safety of the test formulation of adapalene gel 0.1% (PLIVA Research \& Development Ltd.) as compared to the already marketed formulation, Differin® (adapalene 0.1%) topical gel (Galderma Laboratories) in patients with acne vulgaris.
Read the detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria for Comparative Clinical Endpoint Studies.
Statistical Methods: FDA Bioequivalence Statistical Methods for Comparative Clinical Endpoint Studies.
- Conditions
- Acne Vulgaris
- Being tested
- Adapalene, Differin®, Placebo
- Keywords
- Bioequivalence, Acne Vulgaris
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdapaleneDrug
0.1% Topical Gel
Differin®Drug
Also called Adapalene
0.1% Topical Gel
PlaceboDrug
Gel Base
| Study group | Role | What they receive |
|---|---|---|
| Investigational Test Product | Experimental | Adapalene Topical Gel, 0.1% Receives: Drug: Adapalene |
| Reference Listed Drug | Active comparator | Differin® (adapalene 0.1%) Topical Gel Receives: Drug: Differin® |
| Placebo | Placebo comparator | Gel base only Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Reduction from Baseline in Non-Nodular Inflamed Lesion Count
Per Protocol Population (PPP) was assessed for the mean percent reduction compared to baseline in non-nodular lesion count (papules and pustules) at Day 84. If a patient was withdrawn from the study prior to Day 84 for lack of efficacy, then their data was carried forward for this analysis.
Measured: 84 days
Mean Percent Reduction from Baseline in Non-Inflamed Lesion Count
Per Protocol Population (PPP) was assessed for the mean percent reduction in non-inflamed lesion count (open and closed comedones) compared with baseline at Day 84. If a patient was withdrawn from the study prior to Day 84 for lack of efficacy, then their data was carried forward for this analysis.
Measured: 84 days
Safety Analysis
All 601 patients randomized and dispensed study drug were included in the safety analysis. The frequency, severity, and relationship to the study drug for adverse events in each treatment group were used to compare the safety of the study medications.
Measured: 84 Days
Secondary outcomes (3)
Mean Numerical Reduction in Inflamed Lesion Counts
Secondary measure of bioequivalence using the Intent-to-Treat (ITT) population.
Measured: 84 Days
Mean Numerical Reduction in Non-Inflamed Lesion Counts
Secondary measure of bioequivalence using the Intent-to-Treat (ITT) population.
Measured: 84 Days
Proportion of Patients Considered a "Clinical Success" or "Clinical Failure"
Secondary measure of bioequivalence using the Intent-to-Treat (ITT) population. "Clinial Success" or "Clinical Failure" is defined by the Physician's Global Assessment.
Measured: 84 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startJul 2007
- Primary completionApr 2008
- Study completionApr 2008
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 601 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182636
- Sponsor's protocol ID
- 70716202
- Status last verified
- Nov 2010
- First submitted
- 13 Aug 2010
- Last updated
- 24 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multiple-Site, Placebo Controlled, Parallel Design, Clinical Study to Evaluate the Bioequivalence of Adapalene Gel 0.1% (PLIVA Research & Development Ltd.) Compared to Differin® (Adapalene 0.1%) Topical Gel (Galderma Laboratories) in Patients With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT01182636
- Acronym / sponsor ID
- 70716202
- Conditions
- Acne Vulgaris
- Keywords
- Bioequivalence, Acne Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 17 Aug 2010 (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 was to evaluate the efficacy and safety of the test formulation of adapalene gel 0.1% (PLIVA Research \& Development Ltd.) as compared to the already marketed formulation, Differin® (adapalene 0.1%) topical gel (Galderma Laboratories) in patients with acne vulgaris.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria for Comparative Clinical Endpoint Studies.
Statistical Methods: FDA Bioequivalence Statistical Methods for Comparative Clinical Endpoint Studies.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Investigational Test Product | Experimental | Drug: AdapaleneAdapalene Topical Gel, 0.1% |
| Reference Listed Drug | Active comparator | Drug: Differin®Differin® (adapalene 0.1%) Topical Gel |
| Placebo | Placebo comparator | Drug: PlaceboGel base only |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male or non-pregnant, non-lactating female, 12-40 years of age inclusive.
- Signed informed consent form, which meets all the criteria of the current FDA regulations. For patients under the age of majority in the state they are enrolled, the patient's parent or legal guardian will be required to sign the consent form and the patient will sign an IRB approved "assent to participate" form.
- If female and of child bearing potential, prepare to abstain from sexual intercourse or use reliable method of contraception during the study (i.e. condom, Intrauterine device, hormonal contraceptives). Patients on hormonal contraceptives must have been on the same hormonal contraceptive for 3 months prior to the baseline visit and continue throughout the duration of the study.
- Have moderate to severe facial acne as defines as: at least 20 but no more that 60 facial inflammatory lesions (papules and pustules) and at least 25 but no more than 100 non-inflamed lesions (open and closed comedones) and have a Physician's Global Assessment score of 3, 4, or 5.
Key exclusion criteria (15 listed)
- Patient has more than 2 facial nodular lesions, any nodules present will be documented but will not be included in the inflammatory lesion count.
- Patient has active cystic acne.
- Patient has acne conglobate.
- Patient with significant facial hair such as beards or tattoos or excessive facial scarring that, in the Investigator's opinion, may interfere with the evaluation of the patient's acne.
- Patients with facial sunburn.
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 |
|---|---|---|
| Adapalene0.1% Topical Gel | Drug | Investigational Test Product |
| Differin®Also: Adapalene0.1% Topical Gel | Drug | Reference Listed Drug |
| PlaceboGel Base | Drug | Placebo |
Primary outcome
Mean Percent Reduction from Baseline in Non-Nodular Inflamed Lesion Count
Time frame: 84 days
Per Protocol Population (PPP) was assessed for the mean percent reduction compared to baseline in non-nodular lesion count (papules and pustules) at Day 84. If a patient was withdrawn from the study prior to Day 84 for lack of efficacy, then their data was carried forward for this analysis.
Mean Percent Reduction from Baseline in Non-Inflamed Lesion Count
Time frame: 84 days
Per Protocol Population (PPP) was assessed for the mean percent reduction in non-inflamed lesion count (open and closed comedones) compared with baseline at Day 84. If a patient was withdrawn from the study prior to Day 84 for lack of efficacy, then their data was carried forward for this analysis.
Safety Analysis
Time frame: 84 Days
All 601 patients randomized and dispensed study drug were included in the safety analysis. The frequency, severity, and relationship to the study drug for adverse events in each treatment group were used to compare the safety of the study medications.
3 secondary outcomes
Mean Numerical Reduction in Inflamed Lesion Counts
Time frame: 84 Days
Mean Numerical Reduction in Non-Inflamed Lesion Counts
Time frame: 84 Days
Proportion of Patients Considered a "Clinical Success" or "Clinical Failure"
Time frame: 84 Days
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 24 Nov 2010.
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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.
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adapalene and Differin® in people with Acne Vulgaris, run by Teva Pharmaceuticals USA at 22 sites in 2 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 4 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 24 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Belize. 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 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?
Mean Percent Reduction from Baseline in Non-Nodular Inflamed Lesion Count (time frame: 84 days). 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?
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 24 Nov 2010.