Acne Vulgaris on the FaceNCT05779085
Efficacy of a Deep Cleansing Gel Containing 2% Salicylic Acid, 0.2% Zinc Gluconate and 0.05% Lipohydroxy Acid in the Management of Mild to Moderate Facial Acne
An observational study of Acne Vulgaris on the Face, run by Cosmetique Active International at 1 site in Brazil.
Trial summary
A clinical study with 56 healthy subjects (both sexes) aged between 13 to 25 years old. Subjects enrolled had a minimum of 5 inflammatory lesions (papules, nodules and pustules) and 10 non-inflammatory lesions (open and closed comedones), determined by dermatologist. Read more about this study
- Who is it for?
- Ages 13 to 26 years
- Conditions the study is for
- Acne Vulgaris on the Face
- What is being tested?
- Dermocosmetic
- How many people
- 56 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Apr 2013to 22 Jul 2013
- 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 13 to 26 years
- All sexes
- Child, Adult
Study population: Subjects aged between 13 to 25 years of age with mild to moderate acne.
Who may be able to join
- subjects aged 13-25 years
- mild to moderate acne on the face
- signed informed consent
Who cannot join
- subjects below 13 years and above 26 years
- severe acne on the face
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ASSESSMENT OF CLINICAL, INSTRUMENTAL AND NOTICED EFICACY BY SUBJECTS OF A COSMETIC PRODUCT 12.0417.01.090 UNDER NORMAL CONDITIONS OF USE Study With Dermatological Follow-up Including Instrumental Measurements
A clinical study with 56 healthy subjects (both sexes) aged between 13 to 25 years old. Subjects enrolled had a minimum of 5 inflammatory lesions (papules, nodules and pustules) and 10 non-inflammatory lesions (open and closed comedones), determined by dermatologist. The clinical evaluation considered in oiliness, shininess and global aspect of the skin too. Instrumental assessment of oiliness and shininess was performed, respectively, by Sebumeter and Sebutape.
IThe tested cleanser was used twice daily (morning and evening) during 28 days.
- Conditions
- Acne Vulgaris on the Face
- Being tested
- Dermocosmetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermocosmeticOther
Also called Cleanser
Use of daily cleanser to treat facial acne
What is being measured
The primary outcome is the main question the study is designed to answer.
Global lesion count
using GEA scale
Measured: baseline
Global lesion count
using GEA scale
Measured: Day 28
Closed comedones
count
Measured: baseline
Closed comedones
count
Measured: Day 28
papules
count
Measured: baseline
papules
count
Measured: Day 28
skin oiliness
instrumental measurement Sebumeter
Measured: baseline
skin oiliness
instrumental measurement Sebumeter
Measured: Day 28
skin sebutape
instrumental measurement Sebumeter
Measured: baseline
skin sebutape
instrumental measurement Sebumeter
Measured: Day 28
subject satisfaction
questionnaire
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start8 Apr 2013
- Primary completion22 Jul 2013
- Study completion22 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne Vulgaris on the FaceStudies 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779085
- Sponsor's protocol ID
- 090.324.003.12
- Status last verified
- Mar 2023
- First submitted
- 7 Mar 2023
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSESSMENT OF CLINICAL, INSTRUMENTAL AND NOTICED EFICACY BY SUBJECTS OF A COSMETIC PRODUCT 12.0417.01.090 UNDER NORMAL CONDITIONS OF USE Study With Dermatological Follow-up Including Instrumental Measurements
- ClinicalTrials.gov ID
- NCT05779085
- Acronym / sponsor ID
- 090.324.003.12
- Conditions
- Acne Vulgaris on the Face
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2013 (actual)
- Primary completion
- 22 Jul 2013 (actual)
- Study completion
- 22 Jul 2013 (actual)
- First posted
- 22 Mar 2023 (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.
A clinical study with 56 healthy subjects (both sexes) aged between 13 to 25 years old. Subjects enrolled had a minimum of 5 inflammatory lesions (papules, nodules and pustules) and 10 non-inflammatory lesions (open and closed comedones), determined by dermatologist. The clinical evaluation considered in oiliness, shininess and global aspect of the skin too. Instrumental assessment of oiliness and shininess was performed, respectively, by Sebumeter and Sebutape.
IThe tested cleanser was used twice daily (morning and evening) during 28 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 26 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Subjects aged between 13 to 25 years of age with mild to moderate acne.
Key inclusion criteria (3 listed)
- subjects aged 13-25 years
- mild to moderate acne on the face
- signed informed consent
Key exclusion criteria (2 listed)
- subjects below 13 years and above 26 years
- severe acne on the face
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 |
|---|---|---|
| DermocosmeticAlso: CleanserUse of daily cleanser to treat facial acne | Other | – |
Primary outcome
Global lesion count
Time frame: baseline
using GEA scale
Global lesion count
Time frame: Day 28
using GEA scale
Closed comedones
Time frame: baseline
count
Closed comedones
Time frame: Day 28
count
papules
Time frame: baseline
count
papules
Time frame: Day 28
count
skin oiliness
Time frame: baseline
instrumental measurement Sebumeter
skin oiliness
Time frame: Day 28
instrumental measurement Sebumeter
skin sebutape
Time frame: baseline
instrumental measurement Sebumeter
skin sebutape
Time frame: Day 28
instrumental measurement Sebumeter
subject satisfaction
Time frame: Day 28
questionnaire
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 22 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Acne Vulgaris on the Face
RecruitingPhase 3
Study of New Antiandrogenic Progestogen + Low-dose Estrogen for Moderate Acne Vulgaris
Acne Vulgaris, Acne Vulgaris on the Face
Active, not recruitingPhase 2
A Pilot Study Testing Fractional Radiofrequency Versus Fractional Photothermolysis for the Treatment of Acne Scars
Cicatrix
Not yet recruitingObservational study
An Observational Clinical Study to Evaluate the Efficacy of the CeraVe Skin Care Line
Acne
Not yet recruiting
Efficacy and Tolerability of DispersinB Acne Cleanser in the Treatment of Mild to Moderate Acne Vulgaris
Acne Vulgaris on the Face
Not yet recruiting
Clinical Evaluation and Study of the Efficacy of a Centella Asiatica-Infused Facial Mask on Discosmetic Dermatosis
Rosacea, Acne
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.
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 Vulgaris on the Face, 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 3 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 22 Mar 2023. 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?
Global lesion count (time frame: baseline). The study lists 11 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 22 Mar 2023.