Acne ScarsPhase 2NCT01213199
Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars
A Phase 2 study testing Adapalene in people with Acne Scars, run by Galderma R&D at 1 site in United States.
Trial summary
The purpose of this study is to assess the efficacy and safety of Adapalene Gel 0.3% in the treatment of atrophic acne scars. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Acne Scars
- What is being tested?
- Adapalene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Sep 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects of any race, aged 18 to 50 years inclusive
- Subjects with a past history of acne and with moderate to severe facial atrophic acne scars
Who cannot join
- Subjects with active inflammatory acne lesions
- Subjects with hypertrophic acne scars
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars. A Pilot Study.
The purpose of this study is to assess the efficacy and safety of Adapalene Gel 0.3% in the treatment of atrophic acne scars.
- Conditions
- Acne Scars
- Being tested
- Adapalene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdapaleneDrug
Also called Differin 0.3%
Adapalene Gel 0.3%
| Study group | Role | What they receive |
|---|---|---|
| Differin 0.3% | Experimental | Differin® 0.3% Gel
Adapalene 0.3%
Topical to the face, once daily application in the evening for the first four weeks and twice daily application in the morning and in the evening for the following 20 weeks. Receives: Drug: Adapalene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Scarring Severity
Grade Level:
- Macular disease
- Mild disease
- Moderate disease
- Severe disease
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2010 (estimated)
- Study startMar 2011
- Primary completionApr 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acne ScarsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manisha J. Patel, MD, Principal investigator, Johns Hopkins Medical Institut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213199
- Sponsor's protocol ID
- RD.03.SPR.29088
- Status last verified
- Mar 2015
- First submitted
- 30 Sep 2010
- Last updated
- 18 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Loss MJ, Leung S, Chien A, Kerrouche N, Fischer AH, Kang S. Adapalene 0.3% Gel Shows Efficacy for the Treatment of Atrophic Acne Scars. Dermatol Ther (Heidelb). 2018 Jun;8(2):245-257. doi: 10.1007/s13555-018-0231-8. Epub 2018 Mar 16.
PubMed 29549598
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars. A Pilot Study.
- ClinicalTrials.gov ID
- NCT01213199
- Acronym / sponsor ID
- RD.03.SPR.29088
- Conditions
- Acne Scars
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 1 Oct 2010 (estimated)
- Results
- Posted 23 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy and safety of Adapalene Gel 0.3% in the treatment of atrophic acne scars.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Differin 0.3% | Experimental | Drug: AdapaleneDifferin® 0.3% Gel Adapalene 0.3% Topical to the face, once daily application in the evening for the first four weeks and twice daily application in the morning and in the evening for the following 20 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male or female subjects of any race, aged 18 to 50 years inclusive
- Subjects with a past history of acne and with moderate to severe facial atrophic acne scars
Key exclusion criteria (2 listed)
- Subjects with active inflammatory acne lesions
- Subjects with hypertrophic acne scars
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 |
|---|---|---|
| AdapaleneAlso: Differin 0.3%Adapalene Gel 0.3% | Drug | Differin 0.3% |
Primary outcome
Global Scarring Severity
Time frame: Week 24
Grade Level: 1. Macular disease 2. Mild disease 3. Moderate disease 4. Severe disease
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29549598Loss MJ, Leung S, Chien A, Kerrouche N, Fischer AH, Kang S. Adapalene 0.3% Gel Shows Efficacy for the Treatment of Atrophic Acne Scars. Dermatol Ther (Heidelb). 2018 Jun;8(2):245-257. doi: 10.1007/s13555-018-0231-8. Epub 2018 Mar 16.
- Related InfoLink provided by the sponsor.
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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.
Manisha J. Patel, MD principal investigator
Johns Hopkins Medical Institut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adapalene in people with Acne Scars, run by Galderma R&D at 1 site in United States.
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 2 inclusion and 2 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 18 Feb 2021. 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 United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Global Scarring Severity (time frame: Week 24). 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 NCT01213199, which also lists 1 linked publication.
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 18 Feb 2021.