Acne VulgarisPhase 3NCT04329403
Clinical Endpoint Bioequivalence Study of Adapalene Gel 0.1%
A Phase 3 study testing Adapalene 0.1% Gel and Differin 0.1% Topical Gel in people with Acne Vulgaris, run by Aurobindo Pharma Ltd.
Trial summary
To evaluate the therapeutic equivalence of topical Adapalene Gel, 0.1 % and Differin®(Adapalene) Gel, 0.1 % in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo. 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 0.1% Gel and Differin 0.1% Topical Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2020to May 2021
- 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
- Male or nonpregnant, nonlactating female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris
- On the face, ≥ 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)
- Investigator's Global Assessment (IGA) of acne severity Grade 2, 3, or 4
- Willing to refrain from use of all other topical acne medications or antibiotics during the 12-week treatment period
- If female of childbearing potential, willing to use an acceptable form of birth control during the study
Who cannot join
- Pregnant, breast feeding or planning a pregnancy
- 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, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis)
- Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris
- History of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients
- Use within 6 months prior to baseline or during the study of oral retinoids (e.g., Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed)
- Use for less than 3 months prior to baseline of estrogens or oral contraceptives; use of such therapy must remain constant throughout the study
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- Use on the face within 1 month prior to baseline or during the study of 1) cryo destruction or chemo destruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy
- Use within 1 month prior to baseline or during the study of 1) systemic steroids, 2) systemic antibiotics, 3) systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), or 4) systemic anti-inflammatory agents
- Use within 2 weeks prior to baseline or during the study of 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, or 5) topical antibiotics
About this study
Official title: Randomized, Double Blind, Placebo Controlled, Parallel Group Design, Three Arm, Multicentric Study to Evaluate the Efficacy and Safety of Topical Adapalene Gel, 0.1 % in Healthy Males and Nonpregnant Female Subjects With Acne Vulgaris
To evaluate the therapeutic equivalence of topical Adapalene Gel, 0.1 % and Differin®(Adapalene) Gel, 0.1 % in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo.
Read the detailed description
Bio-Equivalence study with a clinical endpoint in the treatment of acne vulgaris comparing adapalene cream, 0.1% test product versus the reference listed drug (RLD) and placebo (vehicle) control, each administered as one application once a day in the evening for 12 weeks
- Conditions
- Acne Vulgaris
- Being tested
- Adapalene 0.1% Gel, Differin 0.1% Topical Gel, 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 0.1% GelDrug
A thin film of the assigned medication to be applied once daily in the evening for 12 weeks
Differin 0.1% Topical GelDrug
A thin film of the assigned medication to be applied once daily in the evening for 12 weeks
PlaceboOther
A thin film of the assigned medication to be applied once daily in the evening for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Adapalene Gel, 0.1%, applied as thin film once daily for 12 weeks Receives: Drug: Adapalene 0.1% Gel |
| Reference Group | Active comparator | Differin® (Adapalene) Gel, 0.1%, applied as thin film once daily for 12 weeks Receives: Drug: Differin 0.1% Topical Gel |
| Placebo Group | Placebo comparator | Placebo Gel, 0.1%, applied as thin film once daily for 12 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percent change from baseline in the inflammatory lesion count.
Mean percent change compared to baseline inflammatory lesion count (papules and pustules) at Day 84 in per protocol population.
Measured: 12 weeks
Mean percent change from baseline in the non-inflammatory lesion count.
Mean percent change compared to baseline non-inflammatory lesion count (open and closed comedones) at Day 84 in per protocol population.
Measured: 12 weeks
Secondary outcomes (2)
Proportion of subjects with a clinical response as success or failure
Success will be defined as IGA score that is at least 2 grades less than the baseline assessment. Failure is defined as an IGA score that is the same, higher or one grade lower than the baseline assessment.
Measured: 12 weeks
Change in lesion count
Percentage of subjects who achieved at least 50 % reduction in lesion counts (inflammatory, non-inflammatory and total lesion count)
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 posted1 Apr 2020
- Study startJul 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionMay 2021 (estimated)
Why it stopped: Market reasons
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurobindo Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329403
- Sponsor's protocol ID
- CR191-18
- Status last verified
- Jun 2020
- First submitted
- 30 Mar 2020
- Last updated
- 26 Jun 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo Controlled, Parallel Group Design, Three Arm, Multicentric Study to Evaluate the Efficacy and Safety of Topical Adapalene Gel, 0.1 % in Healthy Males and Nonpregnant Female Subjects With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT04329403
- Acronym / sponsor ID
- CR191-18
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Market reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aurobindo Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 1 Apr 2020 (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 of topical Adapalene Gel, 0.1 % and Differin®(Adapalene) Gel, 0.1 % in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo.
Detailed description
Bio-Equivalence study with a clinical endpoint in the treatment of acne vulgaris comparing adapalene cream, 0.1% test product versus the reference listed drug (RLD) and placebo (vehicle) control, each administered as one application once a day in the evening for 12 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Drug: Adapalene 0.1% GelAdapalene Gel, 0.1%, applied as thin film once daily for 12 weeks |
| Reference Group | Active comparator | Drug: Differin 0.1% Topical GelDifferin® (Adapalene) Gel, 0.1%, applied as thin film once daily for 12 weeks |
| Placebo Group | Placebo comparator | Other: PlaceboPlacebo Gel, 0.1%, applied as thin film once daily for 12 weeks |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Male or nonpregnant, nonlactating female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris
- On the face, ≥ 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)
- Investigator's Global Assessment (IGA) of acne severity Grade 2, 3, or 4
- Willing to refrain from use of all other topical acne medications or antibiotics during the 12-week treatment period
- If female of childbearing potential, willing to use an acceptable form of birth control during the study
Key exclusion criteria (9 listed)
- Pregnant, breast feeding or planning a pregnancy
- 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, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis)
- Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris
- History of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients
- Use within 6 months prior to baseline or during the study of oral retinoids (e.g., Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed)
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 0.1% GelA thin film of the assigned medication to be applied once daily in the evening for 12 weeks | Drug | Test Group |
| Differin 0.1% Topical GelA thin film of the assigned medication to be applied once daily in the evening for 12 weeks | Drug | Reference Group |
| PlaceboA thin film of the assigned medication to be applied once daily in the evening for 12 weeks | Other | Placebo Group |
Primary outcome
Mean percent change from baseline in the inflammatory lesion count.
Time frame: 12 weeks
Mean percent change compared to baseline inflammatory lesion count (papules and pustules) at Day 84 in per protocol population.
Mean percent change from baseline in the non-inflammatory lesion count.
Time frame: 12 weeks
Mean percent change compared to baseline non-inflammatory lesion count (open and closed comedones) at Day 84 in per protocol population.
2 secondary outcomes
Proportion of subjects with a clinical response as success or failure
Time frame: 12 weeks
Change in lesion count
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adapalene 0.1% Gel and Differin 0.1% Topical Gel in people with Acne Vulgaris, run by Aurobindo Pharma Ltd.
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 5 inclusion and 9 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: withdrawn, as of the sponsor's last update on 26 Jun 2020. 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 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 was withdrawn before enrolling participants, so there are no results.
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 in the inflammatory lesion count. (time frame: 12 weeks). The study lists 2 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 26 Jun 2020.