Acne VulgarisPhase 3NCT03650361
Bioequivalence Study of Adapalene Gel 0.3% in Subjects With Facial Acne Vulgaris
A Phase 3 study testing Adapalene Gel 0.3% and Differin 0.3% Topical Gel in people with Acne Vulgaris, run by Aleor Dermaceuticals Limited at 10 sites in 2 countries.
Trial summary
To evaluate the therapeutic equivalence and safety of Adapalene Gel 0.3% (Aleor Dermaceuticals Limited, India) and Differin® (Adapalene) Gel 0.3% (Galderma Laboratories, LP USA) in the treatment of 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 Gel 0.3% and Differin 0.3% Topical Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 755 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 17 Sep 2018to 16 Feb 2019
- Phase
- Phase 3
- 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 (up to the age of 40 inclusive) must have provided IRB approved written informed consent. Subjects ages 12 to 17 years of age inclusive must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the Subject's legally acceptable representative (i.e., parent or guardian). In addition, all Subjects or their legally acceptable representatives (i.e., parent or guardian) must sign a HIPAA authorization.
- Subjects must have a minimum ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) and ≤ 2 nodulocystic lesions (i.e., nodules and cysts), at baseline on the face. For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area. When counting facial acne lesions, it is important that all lesions be counted, including those present on the nose. Lesions involving the eyes, lip and scalp should be excluded from the count. Subjects may have acne lesions on other areas of the body which will also be excluded from the count, treatment, and the Investigator's Global Assessment (IGA) evaluation (e.g., on the back, chest and arms).
- Subjects must have a definite clinical diagnosis of acne vulgaris of 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 during the 12-week treatment period for acne vulgaris, other than the Investigational Product.
- Female Subjects of childbearing potential (excluding women 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 from the day of the first dose administration to 30 days after the last administration of study drug. For the purpose of this study the following are considered acceptable methods of birth control: oral or injectable contraceptives, contraceptive patches, Depo-Provera® (stabilized for at least 3 months); NuvaRing® (vaginal contraceptive); Implanon™ (contraceptive implant) double barrier methods (e.g. condom and spermicide); IUD, or abstinence. If a subject who was abstinent becomes sexually active during the study, a 2nd acceptable method of birth control should be documented. A sterile sexual partner is NOT considered an adequate form of birth control. Hormonal contraceptives should not be initiated or changed during the study.
Show all 10Show fewer
- 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. Abstinence is an acceptable method of birth control. Female partners should use an acceptable method of birth control as described in the above Item Number 6.
- Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.
- 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. Such conditions include, but are not limited to the following: auto immune disease, rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne; carcinoid syndrome; mastocytosis; acneiform eruptions caused by make-up, medication, facial psoriasis and facial eczema.
- Subjects 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 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 its excipients.
- Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
- Subjects with excessive facial hair (e.g. beards, sideburns, moustaches, etc.) 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 (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
Show all 38Show fewer
- Subjects who have used estrogens or oral contraceptives for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study.
- Subjects who have used any of the following procedures on the face within 1 month prior to baseline or during the study :
- cryodestruction or chemodestruction,
- dermabrasion,
- photodynamic therapy,
- acne surgery,
- intralesional steroids, or
- X-ray therapy.
- Subjects who have used any of the following treatments within 1 month prior to baseline or during the study:
- systemic steroids,
- systemic antibiotics,
- systemic treatment for acne vulgaris (other than oral retinoids which require a 6-month washout), or
- 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, or any other topical acne treatments including over-the-counter preparations
- topical anti-inflammatory agents, or
- topical antibiotics.
- Use of spironolactone within 1 month before Screening/Baseline.
- 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 life-threatening diseases.
- Subjects who have on-going malignancies requiring systemic treatment will be excluded from study participation. In addition, Subjects who have any malignancy of the skin of the facial area will be excluded.
- 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 (greater than two drinks per day) or use drugs of abuse (including, but not limited to cannabinoids, cocaine and barbiturates).
- Subjects who have participated in an investigational drug study (i.e., Subjects have been treated with an Investigational Drug) within 30 days prior to baseline will be excluded from study participation. Subjects who are participating in non-treatment studies such as observational studies or registry studies can be considered for inclusion.
- Subjects who have been previously enrolled in this study.
- Subjects who had laser therapy, electrodessication and phototherapy (e.g., ClearLight®) to the facial area within 1 month prior to study entry.
- Subjects who 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. Cosmetic procedures and facials are prohibited throughout the study
- Subjects who currently have or have recently had bacterial folliculitis on the face.
- Subjects with a baseline irritation score of 3 (severe, marked/intense) for erythema, dryness, burning/stinging, erosion, edema, pain and itching will not be enrolled.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Moore Clinical Research Institute, Inc.
Brandon, Florida, 33511
3A Research, LLC
El Paso, Texas, 79902
3A Research, LLC
El Paso, Texas, 79925
Dermatology Consulting Services, PLLC
High Point, North Carolina, 27262
FXM Research Corp.
Miami, Florida, 33175
FXM Research Miramar
Miramar, Florida, 33027
Unison Center for Clinical Trials
Sherman Oaks, California, 91403
Moore Clinical Research Institute, Inc.
Tampa, Florida, 33609
Moore Clinical Research Institute, Inc.
Tampa, Florida, 33618
Belize1 site
FXM Research International
Belize City
About this study
Official title: A Multi-Center, Double-Blind, Randomized, Three-Arm, Placebo Controlled, Parallel-Group Study, Comparing Adapalene Gel 0.3% To Differin® Gel 0.3% And Both Active Treatments To A Placebo Control In The Treatment Of Acne Vulgaris
To evaluate the therapeutic equivalence and safety of Adapalene Gel 0.3% (Aleor Dermaceuticals Limited, India) and Differin® (Adapalene) Gel 0.3% (Galderma Laboratories, LP USA) in the treatment of acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- Adapalene Gel 0.3%, Differin 0.3% Topical Gel, Adapalene Gel 0.3% Vehicle Placebo
- 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 Gel 0.3%Drug
Treatment applied as a thin layer of the product to the entire face once a day in the evening for 84 days
Differin 0.3% Topical GelDrug
Treatment applied as a thin layer of the product to the entire face once a day in the evening for 84 days
Adapalene Gel 0.3% Vehicle PlaceboDrug
Treatment applied as a thin layer of the product to the entire face once a day in the evening for 84 days
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | Adapalene Gel 0.3% manufactured by Aleor Dermaceuticals Limited, applied for 84 days Receives: Drug: Adapalene Gel 0.3% |
| Reference Product | Active comparator | Adapalene Gel 0.3%, , applied for 84 days Receives: Drug: Differin 0.3% Topical Gel |
| Placebo Control | Placebo comparator | Vehicle of the test product, applied for 84 days Receives: Drug: Adapalene Gel 0.3% Vehicle Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percent change from baseline to week 12 in the inflammatory (papules and pustules) and in the non-inflammatory (open and closed comedones) lesion counts
Uses both modified intent-to-treat (mITT) and per protocol (PP) populations
Measured: 12 weeks
Secondary outcomes (1)
The secondary endpoint is the Investigator Global Assessment (IGA) score, expressed in terms of treatment success or failure.
Uses both modified intent-to-treat (mITT) and per protocol (PP) populations
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start17 Sep 2018
- Primary completion16 Feb 2019
- Study completion16 Feb 2019
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double (Participant, Investigator)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 755 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aleor Dermaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Catawba Research, LLC
- Responsible party
- Sponsor
- Investigators
- Venkata. K. R. CH. Hemanth Varma. P, Study director, Aleor Dermaceuticals Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650361
- Sponsor's protocol ID
- ADPG 1807
- Status last verified
- Apr 2019
- First submitted
- 26 Aug 2018
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Blind, Randomized, Three-Arm, Placebo Controlled, Parallel-Group Study, Comparing Adapalene Gel 0.3% To Differin® Gel 0.3% And Both Active Treatments To A Placebo Control In The Treatment Of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT03650361
- Acronym / sponsor ID
- ADPG 1807
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 755 participants (actual)
- Lead sponsor
- Aleor Dermaceuticals LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Catawba Research, LLC
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 16 Feb 2019 (actual)
- Study completion
- 16 Feb 2019 (actual)
- First posted
- 28 Aug 2018 (actual)
- 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.
To evaluate the therapeutic equivalence and safety of Adapalene Gel 0.3% (Aleor Dermaceuticals Limited, India) and Differin® (Adapalene) Gel 0.3% (Galderma Laboratories, LP USA) in the treatment of acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double (Participant, Investigator)
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Drug: Adapalene Gel 0.3%Adapalene Gel 0.3% manufactured by Aleor Dermaceuticals Limited, applied for 84 days |
| Reference Product | Active comparator | Drug: Differin 0.3% Topical GelAdapalene Gel 0.3%, , applied for 84 days |
| Placebo Control | Placebo comparator | Drug: Adapalene Gel 0.3% Vehicle PlaceboVehicle of the test product, applied for 84 days |
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 (up to the age of 40 inclusive) must have provided IRB approved written informed consent. Subjects ages 12 to 17 years of age inclusive must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the Subject's legally acceptable representative (i.e., parent or guardian). In addition, all Subjects or their legally acceptable representatives (i.e., parent or guardian) must sign a HIPAA authorization.
- Subjects must have a minimum ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) and ≤ 2 nodulocystic lesions (i.e., nodules and cysts), at baseline on the face. For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area. When counting facial acne lesions, it is important that all lesions be counted, including those present on the nose. Lesions involving the eyes, lip and scalp should be excluded from the count. Subjects may have acne lesions on other areas of the body which will also be excluded from the count, treatment, and the Investigator's Global Assessment (IGA) evaluation (e.g., on the back, chest and arms).
- Subjects must have a definite clinical diagnosis of acne vulgaris of 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 during the 12-week treatment period for acne vulgaris, other than the Investigational Product.
Key exclusion criteria (38 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 its excipients.
- Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
- Subjects with excessive facial hair (e.g. beards, sideburns, moustaches, etc.) 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 Gel 0.3%Treatment applied as a thin layer of the product to the entire face once a day in the evening for 84 days | Drug | Test Product |
| Differin 0.3% Topical GelTreatment applied as a thin layer of the product to the entire face once a day in the evening for 84 days | Drug | Reference Product |
| Adapalene Gel 0.3% Vehicle PlaceboTreatment applied as a thin layer of the product to the entire face once a day in the evening for 84 days | Drug | Placebo Control |
Primary outcome
Mean percent change from baseline to week 12 in the inflammatory (papules and pustules) and in the non-inflammatory (open and closed comedones) lesion counts
Time frame: 12 weeks
Uses both modified intent-to-treat (mITT) and per protocol (PP) populations
1 secondary outcome
The secondary endpoint is the Investigator Global Assessment (IGA) score, expressed in terms of treatment success or failure.
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 26 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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.
Venkata. K. R. CH. Hemanth Varma. P study director
Aleor Dermaceuticals Limited
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adapalene Gel 0.3% and Differin 0.3% Topical Gel in people with Acne Vulgaris, run by Aleor Dermaceuticals Limited at 10 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 10 inclusion and 38 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 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 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?
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 change from baseline to week 12 in the inflammatory (papules and pustules) and in the non-inflammatory (open and closed comedones) lesion counts (time frame: 12 weeks). 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 26 Apr 2019.