AcneNCT05584150
The Benefit of a Deep Cleansing Gel in the Management of Mild to Moderate Truncal Acne
An observational study of Acne, run by Cosmetique Active International at 1 site in Brazil.
Trial summary
Acne vulgaris is a chronic inflammatory disease, mainly of the face, but also of the trunk. Acne may be caused by internal and external factors. Only a very small amount of data exists concerning truncal acne. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acne
- What is being tested?
- Deep Cleansing Gel
- How many people
- 35 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2019to 30 Nov 2020
- Phase
- Observational
- 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 18 to 99 years
- All sexes
- Adult, Older adult
Study population: adult female or males with subjects with truncal acne
Who may be able to join
- above 18 years
- truncal acne
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Benefit of a Deep Cleansing Gel Containing Salicylic Acid 2%, Zinc Gluconate 0.2% and Lipohydroxy Acids 0.05% in Patients With Mild to Moderate Truncal Acne: Results From an Exploratory Study
Acne vulgaris is a chronic inflammatory disease, mainly of the face, but also of the trunk. Acne may be caused by internal and external factors. Only a very small amount of data exists concerning truncal acne. The condition affects about 9% of the population worldwide, with 50% of subjects with facial acne also presenting with truncal acne. Until recently, clinicians frequently followed the same therapeutic approach as for facial acne, with treatment adherence remaining an issue.
This study assessed assessed the benefit of a cleansing gel containing salicylic acid 2%, zinc gluconate 0.2% and Lipo hydroxy acids (LHA) 0.05%, used daily for 84 days in mild to moderate truncal acne.
Read the detailed description
For this single center, open label, non-randomized exploratory study, 51 subjects with mild to moderate truncal acne were recruited. The study received ethics committee approval. All subjects provided written informed consent. The investigator evaluated the number of inflammatory, non-inflammatory and total lesions at Baseline, Day 42 and 84. Skin barrier function was appraised via the assessment of transepidermal water loss (TEWL) using a Tewameter® (Courage + Khazaka Electronic GmbH, Germany). Safety was assessed by considering the evaluation of clinical signs and reporting of symptoms, and local adverse reactions. Subjects were asked to gently massage the wet skin of the trunk with the product in the morning and evening for at least 30 seconds, and then thoroughly rinse with tempered water and pat dry.
- Conditions
- Acne
- Being tested
- Deep Cleansing Gel
- Keywords
- truncal acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Cleansing GelOther
daily use
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator global assessment
Scale 0=absent to 5=very serious
Measured: baseline
Investigator global assessment
Scale 0=absent to 5=very serious
Measured: Day 42
Investigator global assessment
Scale 0=absent to 5=very serious
Measured: Day 84
Secondary outcomes (21)
inflammatory lesion count
count and percentage reduction
Measured: baseline
inflammatory lesion count
count and percentage reduction
Measured: Day 42
inflammatory lesion count
count and percentage reduction
Measured: Day 84
non-inflammatory lesion count
count and percentage reduction
Measured: baseline
non-inflammatory lesion count
count and percentage reduction
Measured: Day 42
non-inflammatory lesion count
count and percentage reduction
Measured: Day 84
total lesion count
count and percentage reduction
Measured: baseline
total lesion count
count and percentage reduction
Measured: Day 42
total lesion count
count and percentage reduction
Measured: Day 84
acne severity
scale 0=absent to 5=very severe
Measured: baseline
acne severity
scale 0=absent to 5=very severe
Measured: Day 42
acne severity
scale 0=absent to 5=very severe
Measured: Day 84
transepidermal water loss
tewameter assessment
Measured: baseline
transepidermal water loss
tewameter assessment
Measured: Day 42
transepidermal water loss
tewameter assessment
Measured: Day 84
clinical safety
assessment of clinical signs symptoms and adverse events
Measured: baseline
clinical safety
assessment of clinical signs symptoms and adverse events
Measured: Day 42
clinical safety
assessment of clinical signs symptoms and adverse events
Measured: Day 84
subject efficacy perception
scale 0=none to 5= very good
Measured: Day 42
subject efficacy perception
scale 0=none to 5= very good
Measured: Day 84
subject product perception
sacle 0=bad to 5 very good
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start1 Oct 2019
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcneStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Delphine Kerob, MD, Study director, La Roche-Posay Laboratoire Dermatologique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584150
- Sponsor's protocol ID
- 1819CBCL747
- Status last verified
- Sep 2022
- First submitted
- 25 Sep 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Towersey L, Correia P, Fajgenbaum Feiges M, Euzebio Goncalves Junior J, Sant'Anna B, Kerob D, Le Floc'h C. Assessment of the Benefit of a Deep Cleansing Gel Containing Salicylic Acid 2%, Zinc Gluconate 0.2% and Lipohydroxy Acids 0.05% in Patients with Mild to Moderate Truncal Acne: Results from an Exploratory Study. Clin Cosmet Investig Dermatol. 2023 Jan 18;16:119-123. doi: 10.2147/CCID.S394123. eCollection 2023.
PubMed 36698447
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Benefit of a Deep Cleansing Gel Containing Salicylic Acid 2%, Zinc Gluconate 0.2% and Lipohydroxy Acids 0.05% in Patients With Mild to Moderate Truncal Acne: Results From an Exploratory Study
- ClinicalTrials.gov ID
- NCT05584150
- Acronym / sponsor ID
- 1819CBCL747
- Conditions
- Acne
- Keywords
- truncal acne
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 18 Oct 2022 (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.
Acne vulgaris is a chronic inflammatory disease, mainly of the face, but also of the trunk. Acne may be caused by internal and external factors. Only a very small amount of data exists concerning truncal acne. The condition affects about 9% of the population worldwide, with 50% of subjects with facial acne also presenting with truncal acne. Until recently, clinicians frequently followed the same therapeutic approach as for facial acne, with treatment adherence remaining an issue.
This study assessed assessed the benefit of a cleansing gel containing salicylic acid 2%, zinc gluconate 0.2% and Lipo hydroxy acids (LHA) 0.05%, used daily for 84 days in mild to moderate truncal acne.
Detailed description
For this single center, open label, non-randomized exploratory study, 51 subjects with mild to moderate truncal acne were recruited. The study received ethics committee approval. All subjects provided written informed consent. The investigator evaluated the number of inflammatory, non-inflammatory and total lesions at Baseline, Day 42 and 84. Skin barrier function was appraised via the assessment of transepidermal water loss (TEWL) using a Tewameter® (Courage + Khazaka Electronic GmbH, Germany). Safety was assessed by considering the evaluation of clinical signs and reporting of symptoms, and local adverse reactions. Subjects were asked to gently massage the wet skin of the trunk with the product in the morning and evening for at least 30 seconds, and then thoroughly rinse with tempered water and pat dry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adult female or males with subjects with truncal acne
Key inclusion criteria (2 listed)
- above 18 years
- truncal acne
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Deep Cleansing Geldaily use | Other | – |
Primary outcome
Investigator global assessment
Time frame: baseline
Scale 0=absent to 5=very serious
Investigator global assessment
Time frame: Day 42
Scale 0=absent to 5=very serious
Investigator global assessment
Time frame: Day 84
Scale 0=absent to 5=very serious
21 secondary outcomes
inflammatory lesion count
Time frame: baseline
inflammatory lesion count
Time frame: Day 42
inflammatory lesion count
Time frame: Day 84
non-inflammatory lesion count
Time frame: baseline
non-inflammatory lesion count
Time frame: Day 42
non-inflammatory lesion count
Time frame: Day 84
total lesion count
Time frame: baseline
total lesion count
Time frame: Day 42
total lesion count
Time frame: Day 84
acne severity
Time frame: baseline
acne severity
Time frame: Day 42
acne severity
Time frame: Day 84
transepidermal water loss
Time frame: baseline
transepidermal water loss
Time frame: Day 42
transepidermal water loss
Time frame: Day 84
clinical safety
Time frame: baseline
clinical safety
Time frame: Day 42
clinical safety
Time frame: Day 84
subject efficacy perception
Time frame: Day 42
subject efficacy perception
Time frame: Day 84
subject product perception
Time frame: Day 84
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 18 Oct 2022.
- Derived from this study: PubMed 36698447Towersey L, Correia P, Fajgenbaum Feiges M, Euzebio Goncalves Junior J, Sant'Anna B, Kerob D, Le Floc'h C. Assessment of the Benefit of a Deep Cleansing Gel Containing Salicylic Acid 2%, Zinc Gluconate 0.2% and Lipohydroxy Acids 0.05% in Patients with Mild to Moderate Truncal Acne: Results from an Exploratory Study. Clin Cosmet Investig Dermatol. 2023 Jan 18;16:119-123. doi: 10.2147/CCID.S394123. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Delphine Kerob, MD study director
La Roche-Posay Laboratoire Dermatologique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne, run by Cosmetique Active International at 1 site in Brazil.
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 1 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 Oct 2022. 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 Brazil. 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.
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?
Investigator global assessment (time frame: baseline). 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 NCT05584150, 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 Oct 2022.