AcneNCT05601960
A Combination Treatment Reduces Acne Severity and PIHP
An observational study of Acne and Postinflammatory Hyperpigmentation, run by Cosmetique Active International at 1 site in United Arab Emirates.
Trial summary
Acne is a chronic, inflammatory skin condition. It may cause scars and post-inflammatory hyperpigmentation (PIHP). PIHP frequently affects individuals with a phototype of IV or above.[1] PIHP is worsened by UV radiation, lasts for years and impacts the individual well-being.[2, 3] In an observational study, 1785… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne, Postinflammatory Hyperpigmentation
- What is being tested?
- anti-acne dermocosmetic
- How many people
- 1,785 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 15 Apr 2020to 28 Feb 2021
- How long will I take part?
- 1 Year
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Adult subjects with mild to moderate acne, post-inflammatory hyperpigmentation and of any phototype were suitable for this study.
Who may be able to join
- adult
- mild to moderate acne
- presence of postinflammatory hyperpigmentation lesions
- phototype IV to VI
Who cannot join
- less than 18 years
- severe acne
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Combination of a Dermocosmetic and a Tainted Sunscreen Reduce Acne Severity and Signs of Post-inflammatory Hyperpigmentation in Subjects With a Fitzpatrick Phototype Ranging From IV to VI
Acne is a chronic, inflammatory skin condition. It may cause scars and post-inflammatory hyperpigmentation (PIHP). PIHP frequently affects individuals with a phototype of IV or above.[1] PIHP is worsened by UV radiation, lasts for years and impacts the individual well-being.[2, 3] In an observational study, 1785 adults with a phototype ranging from IV to VI with acne and PIHP applied daily for 2 months a dermocosmetic and a tainted sunscreen product (DC, Effaclar® Duo (+); SS, Anthelios® Shaka Fluide SPF 50+, SS; both La Roche-Posay Laboratoire Dermatologique, France.
- Conditions
- Acne, Postinflammatory Hyperpigmentation
- Being tested
- anti-acne dermocosmetic
- Medical subject headings
- Acne Vulgaris, Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-acne dermocosmeticOther
Also called Sun screen
Topical application once daily for 2 months
What is being measured
The primary outcome is the main question the study is designed to answer.
seborrhoea level
visual analog scale scale 0=none to 10= very severe
Measured: baseline
seborrhoea level
visual analog scale 0=none to 10= very severe
Measured: Month 2
acne severity
GEA (Global evaluation of acne) scale 0=none to 5=very severe
Measured: baseline
acne severity
GEA (Global evaluation of acne) scale 0=none to 5=very severe
Measured: Month 2
PAHPI: post-acne hyperpigmentation index
post-acne hyperpigmentation index from <3mm to >10mm
Measured: baseline
PAHPI: post-acne hyperpigmentation index
post-acne hyperpigmentation index from <3mm to >10mm
Measured: Month 2
inflammatory lesions
lesion count
Measured: baseline
inflammatory lesions
lesion count
Measured: Month 2
non-inflammatory lesions
lesion count
Measured: baseline
non-inflammatory lesions
lesion count
Measured: Month 2
Secondary outcomes (5)
Investigator satisfaction acne
visual analog scale from very unsatified=0 to very satisfied=5
Measured: Month 2
Investigator satisfaction
visual analog scale from very unsatified=0 to very satisfied=5
Measured: Month 2
Patient satisfaction acne
visual analog scale from very unsatified=0 to very satisfied=5
Measured: Month 2
Patient satisfaction PAHPI
visual analog scale from very unsatified=0 to very satisfied=5
Measured: Month 2
Patient: Skin quality
visual analog scale from very unsatified=0 to very satisfied=5
Measured: Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start15 Apr 2020
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1,785 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rana Shabab, Principal investigator, Dermatique Skin Care, Khobar, KSA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601960
- Sponsor's protocol ID
- LRP19009
- Status last verified
- Oct 2022
- First submitted
- 25 Oct 2022
- Last updated
- 1 Nov 2022
- 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 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combination of a Dermocosmetic and a Tainted Sunscreen Reduce Acne Severity and Signs of Post-inflammatory Hyperpigmentation in Subjects With a Fitzpatrick Phototype Ranging From IV to VI
- ClinicalTrials.gov ID
- NCT05601960
- Acronym / sponsor ID
- LRP19009
- Conditions
- Acne, Postinflammatory Hyperpigmentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,785 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 1 Nov 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 is a chronic, inflammatory skin condition. It may cause scars and post-inflammatory hyperpigmentation (PIHP). PIHP frequently affects individuals with a phototype of IV or above.[1] PIHP is worsened by UV radiation, lasts for years and impacts the individual well-being.[2, 3] In an observational study, 1785 adults with a phototype ranging from IV to VI with acne and PIHP applied daily for 2 months a dermocosmetic and a tainted sunscreen product (DC, Effaclar® Duo (+); SS, Anthelios® Shaka Fluide SPF 50+, SS; both La Roche-Posay Laboratoire Dermatologique, France.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult subjects with mild to moderate acne, post-inflammatory hyperpigmentation and of any phototype were suitable for this study.
Key inclusion criteria (4 listed)
- adult
- mild to moderate acne
- presence of postinflammatory hyperpigmentation lesions
- phototype IV to VI
Key exclusion criteria (2 listed)
- less than 18 years
- severe acne
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 |
|---|---|---|
| anti-acne dermocosmeticAlso: Sun screenTopical application once daily for 2 months | Other | – |
Primary outcome
seborrhoea level
Time frame: baseline
visual analog scale scale 0=none to 10= very severe
seborrhoea level
Time frame: Month 2
visual analog scale 0=none to 10= very severe
acne severity
Time frame: baseline
GEA (Global evaluation of acne) scale 0=none to 5=very severe
acne severity
Time frame: Month 2
GEA (Global evaluation of acne) scale 0=none to 5=very severe
PAHPI: post-acne hyperpigmentation index
Time frame: baseline
post-acne hyperpigmentation index from <3mm to >10mm
PAHPI: post-acne hyperpigmentation index
Time frame: Month 2
post-acne hyperpigmentation index from <3mm to >10mm
inflammatory lesions
Time frame: baseline
lesion count
inflammatory lesions
Time frame: Month 2
lesion count
non-inflammatory lesions
Time frame: baseline
lesion count
non-inflammatory lesions
Time frame: Month 2
lesion count
5 secondary outcomes
Investigator satisfaction acne
Time frame: Month 2
Investigator satisfaction
Time frame: Month 2
Patient satisfaction acne
Time frame: Month 2
Patient satisfaction PAHPI
Time frame: Month 2
Patient: Skin quality
Time frame: Month 2
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 1 Nov 2022.
- 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.
Rana Shabab principal investigator
Dermatique Skin Care, Khobar, KSA
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 and Postinflammatory Hyperpigmentation, run by Cosmetique Active International at 1 site in United Arab Emirates.
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 4 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 1 Nov 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 United Arab Emirates. 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?
seborrhoea level (time frame: baseline). The study lists 10 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 1 Nov 2022.