Acne VulgarisNCT01095640

Study Comparing 0.3% Adapalene Topical Gel to Differin® 0.3% Adapalene Topical Gel

A study testing adapalene 0.3% topical gel in people with Acne Vulgaris, run by Actavis Mid-Atlantic LLC at 1 site in India.

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

Marketed by Galderma Laboratories, L.P., Differin® (adapalene 0.3% topical gel) is a safe and effective topical therapy used for the treatment of acne vulgaris. Actavis Mid-Atlantic LLC has developed a generic formulation of adapalene 0.3% topical gel and the current study is designed to evaluate the safety and… 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 0.3% topical gel
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,159 participants
Where: 1 siteIndia
Study dates: Mar 2009to Dec 2009
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 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Male or female patients must be 12 years old or older.
Patients who are 18 years of age or older must have provided IRB approved written informed consent. Patients between the ages of 12 to 17 years of age must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the patient's legally acceptable representative (i.e., parent or guardian). In addition, all patients or their legally acceptable representatives (i.e., parent or guardian) must sign a HIPAA authorization, if applicable
Patients must have a definite clinical diagnosis of acne vulgaris of mild to moderate severity (Grade 2 or Grade 3 on the IGE).
Patients must have a minimum of 20 and a maximum of 60 facial inflammatory lesions at baseline. Patients must also have a minimum of 20 and a maximum of 75 facial comedones at baseline. Patients may have no more than one (1) nodulo-cystic lesion at baseline. For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area. Lesions involving the eyes, angles of the nose (i.e., the lines around your nostrils and under the nostrils) and scalp should be excluded from the count. Patients may have acne lesions on other areas of the body (e.g., on the back).
Female patients of childbearing potential must have been using and must agree to continue to practice abstinence or use accepted methods of birth control, from 30 days prior to study entry to 30 days after the last administration of study drug. All female patients are considered to be of childbearing potential unless they have been surgically sterilized or have been postmenopausal for at least 1 year. Abstinence is an acceptable method of birth control. Alternatively, any of the following methods of birth control are acceptable: oral contraceptives, contraceptive patches/implants (e.g., Norplant®) Depo-Provera®, double barrier methods (e.g., condom and spermicide) or IUD. Female patients must have a negative urine pregnancy test at baseline.
All male patients 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. Abstinence is an acceptable method of birth control. Alternatively, any of the following methods of birth control are acceptable: oral contraceptives, contraceptive patches/implants (e.g., Norplant®), Depo-Provera®, double barrier methods (e.g., condom and spermicide) or IUD.

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Patients must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.
Patients must be willing to refrain from using any treatments for acne vulgaris, other than the investigational product, for acne present on the face. Patients may use other topical acne treatments that do not have significant or measurable systemic absorption for treatment of acne of the back, shoulders and chest (e.g., benzoyl peroxide, salicylic acid).
Patients 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. Such conditions include, but are not limited to the following: rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne; carcinoid syndrome; mastocytosis; acneiform eruptions caused by make-up, medication, facial psoriasis and facial eczema.
Patients who use make-up must have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and must agree to not change make-up brand/type or frequency of use throughout the study.

Who cannot join

Female patients who are pregnant, nursing or planning to become pregnant during study participation (Visit 1 through Visit 5 or Early Discontinuation Visit) will be excluded from study participation.
Patients who have a known hypersensitivity to adapalene and its excipients will be excluded from study participation.
Patients who have acne congoblata, acne fulimans, and secondary acne (e.g., chloracne and drug induced acne) will be excluded from participation.
Patients who have been treated with systemic antibiotics or systemic anti-acne drugs within 30 days prior to baseline will be excluded from study participation.
Patients who have been treated with prescription and/or over-the-counter topical medications for the treatment of acne vulgaris including antibiotics, topical corticosteroids or topical anti-inflammatory medications on the face within 14 days prior to baseline will be excluded from study participation.
Patients who are currently taking or have been treated with corticosteroids (including intranasal or inhaled corticosteroids) within 30 days prior to baseline will be excluded from study participation.

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Patients who have started hormonal therapy or changed the dosage of their hormonal therapy within 30 days prior to baseline will be excluded from study participation. The dosage and frequency of use of any hormonal therapy started greater than 30 days prior to baseline must remain unchanged throughout the study (Visit 1 through Visit 5 or Early Discontinuation Visit). Hormonal treatments include, but are not limited to, estrogenic and progestational agents such as birth control pills.
Patients who have received oral retinoids (e.g., isotretinoin) within 180 days prior to study entry or have applied topical retinoids (e.g., tretinoin, tazarotene, adapalene) to the face within the 30 days prior to baseline will be excluded from study participation.
Patients who have received radiation therapy and/or anti-neoplastic agents within 90 days prior to baseline will be excluded from study participation.
Patients who have unstable medical disorders that are clinically significant or life-threatening diseases will be excluded from study participation.
Patients who have on-going malignancies requiring systemic treatment will be excluded from study participation. In addition, patients who have any malignancy of the skin of the facial area will be excluded from study participation.
Patients who have facial hair will be excluded from study participation. Unacceptable facial hair includes, but is not limited to, beards and long side-burns. A well-trimmed mustache is acceptable. Patients who have performed wax epilation of the face within 14 days prior to baseline will also be excluded from study participation.
Patients who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold, will be excluded from study participation.
Patients who consume excessive amounts of alcohol (greater than two drinks per day) or use drugs of abuse (including, but not limited to, cannabinoids, cocaine and barbiturates)as judged by history will be excluded from study participation.
Patients who have participated in an investigational drug study (i.e., patients have been treated with an investigational drug) within 30 days prior to baseline will be excluded from study participation. Patients who are participating in non-treatment studies such as observational studies or registry studies can be considered for inclusion.
Patients who have been previously enrolled in this study will be excluded from study participation.
Patients who have had laser therapy, electrodessication and phototherapy (e.g., ClearLight®) to the facial area within 180 days prior to study entry will be excluded from participation.
Patients who have had cosmetic procedures (e.g., facials) which may affect the efficacy and safety profile of the investigational product within 14 days prior to study entry will be excluded from participation.
Patients who currently have or have recently had bacterial folliculitis will be excluded from participation.
Patients who have a baseline local irritation score of 3 (severe, marked/intense) as scored using the Local Irritation Scale (Section 5.2) will be excluded from participation.

Trial locations and contacts

1 site in 1 country.

India1 site

L.T.M. Medical College & General Hospital
Mumbai

Other trials in India

About this study

Official title: A Multicenter, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study Comparing 0.3% Adapalene Topical Gel (Actavis Mid Atlantic LLC) to Differin® (0.3 % Adapalene Topical Gel) (Galderma Laboratories, L.P.) and Both Active Treatments to a Vehicle Control (Actavis Mid Atlantic LLC) in the Treatment of Mild to Moderate Acne Vulgaris

Conditions: Acne Vulgaris
Being tested: adapalene 0.3% topical gel
Keywords: acne, adapalene, Differin
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 0.3% topical gelDrug
once a day, 84 days

Study groups in NCT01095640
Study group	Role	What they receive
adapalene 0.3% topical gel (Actavis Mid-Atlaqntic LLC)	Experimental	Not described Receives: Drug: adapalene 0.3% topical gel
Differin® (adapalene 0.3% topical gel)	Active comparator	Not described Receives: Drug: adapalene 0.3% topical gel
Vehicle Control	Placebo comparator	Not described Receives: Drug: adapalene 0.3% topical gel

What is being measured

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

Therapeutic Equivalence
The primary equivalence comparison is that between the test and reference products for the mean percent change from baseline in the inflammatory lesion counts, the non-inflammatory lesion counts and the proportion of "success" patients at Visit 5, as measured using the Investigator's Global Evaluation (IGE).
Measured: 12 weeks
Superiority
The primary superiority evaluations are the comparisons between each active treatment and the vehicle control relative to the mean percent change in the inflammatory lesion counts, the non-inflammatory lesion counts and the proportion of "success" patients at Visit 5, as measured using the IGE.
Measured: 12 Weeks
Safety
All treatment-emergent adverse events reported during the study will be summarized in order to assess safety.
Measured: 12 Weeks

Secondary outcomes (1)

Total Lesions
The secondary efficacy measure is the mean percent reduction in the total lesion count (inflammatory lesion count + non-inflammatory lesion count) at Visit 5.
Measured: 12 Weeks

Timeline

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

Mar 2009Dec 2009

First posted30 Mar 2010 (estimated)
Study startMar 2009
Primary completionDec 2009
Study completionDec 2009

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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,159 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01095640
Sponsor's protocol ID: ADAP-0.3/2008
Status last verified: Mar 2010
First submitted: 26 Mar 2010
Last updated: 30 Mar 2010
Results posted: No
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

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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study Comparing 0.3% Adapalene Topical Gel (Actavis Mid Atlantic LLC) to Differin® (0.3 % Adapalene Topical Gel) (Galderma Laboratories, L.P.) and Both Active Treatments to a Vehicle Control (Actavis Mid Atlantic LLC) in the Treatment of Mild to Moderate Acne Vulgaris
ClinicalTrials.gov ID: NCT01095640
Acronym / sponsor ID: ADAP-0.3/2008
Conditions: Acne Vulgaris
Keywords: acne, adapalene, Differin
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,159 participants (actual)
Lead sponsor: Actavis Mid-Atlantic LLCIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 30 Mar 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
adapalene 0.3% topical gel (Actavis Mid-Atlaqntic LLC)	Experimental	Drug: adapalene 0.3% topical gel
Differin® (adapalene 0.3% topical gel)	Active comparator	Drug: adapalene 0.3% topical gel
Vehicle Control	Placebo comparator	Drug: adapalene 0.3% topical gel

Who may qualify

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

Key inclusion criteria (10 listed)

Male or female patients must be 12 years old or older.
Patients who are 18 years of age or older must have provided IRB approved written informed consent. Patients between the ages of 12 to 17 years of age must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the patient's legally acceptable representative (i.e., parent or guardian). In addition, all patients or their legally acceptable representatives (i.e., parent or guardian) must sign a HIPAA authorization, if applicable
Patients must have a definite clinical diagnosis of acne vulgaris of mild to moderate severity (Grade 2 or Grade 3 on the IGE).
Patients must have a minimum of 20 and a maximum of 60 facial inflammatory lesions at baseline. Patients must also have a minimum of 20 and a maximum of 75 facial comedones at baseline. Patients may have no more than one (1) nodulo-cystic lesion at baseline. For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area. Lesions involving the eyes, angles of the nose (i.e., the lines around your nostrils and under the nostrils) and scalp should be excluded from the count. Patients may have acne lesions on other areas of the body (e.g., on the back).
Female patients of childbearing potential must have been using and must agree to continue to practice abstinence or use accepted methods of birth control, from 30 days prior to study entry to 30 days after the last administration of study drug. All female patients are considered to be of childbearing potential unless they have been surgically sterilized or have been postmenopausal for at least 1 year. Abstinence is an acceptable method of birth control. Alternatively, any of the following methods of birth control are acceptable: oral contraceptives, contraceptive patches/implants (e.g., Norplant®) Depo-Provera®, double barrier methods (e.g., condom and spermicide) or IUD. Female patients must have a negative urine pregnancy test at baseline.

Key exclusion criteria (20 listed)

Female patients who are pregnant, nursing or planning to become pregnant during study participation (Visit 1 through Visit 5 or Early Discontinuation Visit) will be excluded from study participation.
Patients who have a known hypersensitivity to adapalene and its excipients will be excluded from study participation.
Patients who have acne congoblata, acne fulimans, and secondary acne (e.g., chloracne and drug induced acne) will be excluded from participation.
Patients who have been treated with systemic antibiotics or systemic anti-acne drugs within 30 days prior to baseline will be excluded from study participation.
Patients who have been treated with prescription and/or over-the-counter topical medications for the treatment of acne vulgaris including antibiotics, topical corticosteroids or topical anti-inflammatory medications on the face within 14 days prior to baseline will be excluded from study participation.

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 0.3% topical gelonce a day, 84 days	Drug	Differin® (adapalene 0.3% topical gel), Vehicle Control, adapalene 0.3% topical gel (Actavis Mid-Atlaqntic LLC)

Primary outcome

Therapeutic Equivalence
Time frame: 12 weeks
The primary equivalence comparison is that between the test and reference products for the mean percent change from baseline in the inflammatory lesion counts, the non-inflammatory lesion counts and the proportion of "success" patients at Visit 5, as measured using the Investigator's Global Evaluation (IGE).
Superiority
Time frame: 12 Weeks
The primary superiority evaluations are the comparisons between each active treatment and the vehicle control relative to the mean percent change in the inflammatory lesion counts, the non-inflammatory lesion counts and the proportion of "success" patients at Visit 5, as measured using the IGE.
Safety
Time frame: 12 Weeks
All treatment-emergent adverse events reported during the study will be summarized in order to assess safety.

1 secondary outcome

Total Lesions
Time frame: 12 Weeks

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 30 Mar 2010.

Related trials for Acne Vulgaris

Not yet recruiting
Evaluating a Brightening Serum for Post-Inflammatory Hyperpigmentation
Post-inflammatory Hyperpigmentation, Post-acne Hyperpigmentation
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
Enrolling by invitationPhase 2/3
A Split-Face Comparative Study of Mono Threads Versus Combination With Plasma Gel for the Treatment of Post-Acne Scars
Acne
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 3
Study of New Antiandrogenic Progestogen + Low-dose Estrogen for Moderate Acne Vulgaris
Acne Vulgaris, Acne Vulgaris on the Face

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.

Vishal B., MD principal investigator

Yenepoya Medical College

Bela J. Shah, MD principal investigator

GMC and SSG Hospital

Mhaske, MD principal investigator

B. J. Medical College and Hospital

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

Questions about this trial

What is this clinical trial studying?

A study testing adapalene 0.3% topical gel in people with Acne Vulgaris, run by Actavis Mid-Atlantic LLC at 1 site in India.

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 20 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 30 Mar 2010. 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 India. 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.

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?

Therapeutic Equivalence (time frame: 12 weeks). 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 NCT01095640.

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 30 Mar 2010.