AcneNCT06822335
Clinical Efficacy of the Product in the Management of Facial Post Inflammatory Hyperpigmentation (PIHP) Subjects
An observational study of Acne and Post-inflammatory Hyperpigmentation, run by Cosmetique Active International at 1 site in Mauritius.
Trial summary
Double-blind, randomized, clinical study is designed to evaluate the efficacy of Niacinamide A in the management of facial Post Inflammatory Hyper Pigmentation (PIHP) in healthy female and male subjects with moderate to severe PIHP due to acne, mild acne and (≤4) inflammatory lesions, its impact on skin lightening… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Acne, Post-inflammatory Hyperpigmentation
- How many people
- 65 participants
- Where
- 1 siteMauritius
- Study dates
- 3 Apr 2023to 8 Aug 2023
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: female and male subjects with (Fitzpatrick phototype III-VI), aged between 18 and 50 years old, with moderate to severe PIHP due to acne (score PIHP > 10), with mild acne (GEA 2) and having inflammatory lesions (≤ 4 <10).
Who may be able to join
- Female and male subjects aged between 18 - 50 years old.
- Subject of Fitzpatrick phototype III-VI.
- Subject must be willing and be able to comply with the study schedule, procedures, and restrictions.
- Subjects with moderate to severe scores (4-8) on mean darkness intensity.
- Subjects with moderate to severe PIHP due to acne (score PAPHI>10).
- Subjects with mild acne (GEA 2),
- Subjects having ≤ 4 inflammatory lesions total,
- Subjects showing understanding of the study procedures, restrictions, willingness to participate as evidenced by voluntary written informed consent.
Who cannot join
- Pregnant or intending to become pregnant during the study or breastfeeding or in menopause.
- Subjects under any hormonal therapy, such as contraceptive pills or androgen agonist/antagonist medications, within the last 3 months before Visit 1 or planning to start any therapy during the study.
- Subject with cutaneous pathology on the studied zone other than acne (eczema etc.).
- Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the acceptability and efficacy of the studied products (according to the investigator's appreciation).
- Moderate to severe acne (GEA >2).
- Systemic treatment of retinoids during the six previous months of the study.
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- Under retinoid treatment within the last 6 months, including Over. The Counter (OTC) and all derivates of retinoids (e.g., retinol, retinal, retinaldehyde, retinol esters, etc.).
- Under any acne medication (including oral medication/laser treatment) within the last 6 months.
- Subjects treated for PIHP within the past 3 months with either a cosmetic product or a drug.
- Subject with make-up products on the day of the visit at the center.
- Cosmetic product for non-comedogenicity within the last 2 weeks.
- History of skin cancer.
- History of abnormal response to sun.
- Presence of recent suntan (according to Investigator opinion) or photo-test marks.
- History of allergy, hypersensitivity, or any serious reaction to any cosmetic product.
- Any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator.
- Having used within the month before inclusion any systemic medication for more than 5 consecutive days (e.g., steroidal, and non-steroidal anti-inflammatory drugs, corticoids, insulin, antihistamines, antihypertensive, antibiotics -e.g., quinolone, tetracycline, thiazides, fluoroquinolones-).
- Any subject who, in the judgment of the Investigator, should not participate in the study.
- Subject who cannot be contacted by telephone in case of emergency.
- Subject having participated within the 14 days before inclusion or currently participating in another clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Niacinamide a in the Management of Facial Post Inflammatory Hyperpigmentation (PIHP) Test Under Dermatological Control
Double-blind, randomized, clinical study is designed to evaluate the efficacy of Niacinamide A in the management of facial Post Inflammatory Hyper Pigmentation (PIHP) in healthy female and male subjects with moderate to severe PIHP due to acne, mild acne and (≤4) inflammatory lesions, its impact on skin lightening effect and lastly any associated benefits on skin quality.
Read the detailed description
Primary objective To investigate the depigmenting effect of Niacinamide A in moderate to severe facial post inflammatory hyperpigmentation due to acne after a 12-week application period.
Secondary objectives
To evaluate any associated benefit of the product on skin condition and skin imperfection at different timepoints:
Product lightening efficacy using the Spectrocolorimeter. Evaluation of the global assessment evaluation for acne severity by the investigator using a 6 -point scale.
Counting of non-inflammatory and inflammatory lesions to access the change on the face.
Investigator scoring to assess the local intolerance (erythema, edema, dryness).
Subject scoring to assess the local intolerance(burning, stinging, itching and tingling sensations).
Subjective assessment of global tolerance of the product using a 4-point scale. Skin imaging analysis to assess the evaluation of the PIHP(darkness, size, number brown spots).
Evaluation of the mean darkness. Subjective evaluation of Global Assessment(SGA). Subject questionnaires to assess consumer perceived skin endpoints by filling in a cosmetic evaluation questionnaire and a stigmatization questionnaire.
- Conditions
- Acne, Post-inflammatory Hyperpigmentation
- Medical subject headings
- Acne Vulgaris, Hyperpigmentation
What is being measured
The primary outcome is the main question the study is designed to answer.
POST ACNE HYPERPIGMENTATION INDEX (PAHPI)
The scoring will be performed by the Investigator with the PAHPI at etch visites. The score is composed by 3 parameters: Median Lesion size with 4 grades ( <3mm, 3-6mm, 7-10mm, >10 mm) , intensity with 3 grades ( slightly darker, Moderate darker, significant darker) and number of PIHP lesions with5 grades ( 01-15 lesions, 16-30 lesions, 31-45 lesions, 46-60 lésions, >60 lesions . The global score will be calculated (6 to 22).
Measured: From baseline to Days 84
Secondary outcomes (2)
CLINICAL ASSESSMENT OF ACNE SEVERITY
The dermatologist evaluates the acne severity according to the Global Acne Evaluation with the scale of 5 grades (0 Clear) to 5 ( Very severe)
Measured: From baseline to Days 84
Subject Global Assessment
Global Evaluation with 6 grades ( -1, Worsered; 4 : Totally Cleared)
Measured: From baseline to Days 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start3 Apr 2023
- Primary completion7 Aug 2023
- Study completion8 Aug 2023
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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gitanjali Gitanjali, MBBS, DDV, Principal investigator, CIDP Ltée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822335
- Sponsor's protocol ID
- 2223CMCL076 _ LRP 22061
- Status last verified
- Aug 2023
- First submitted
- 16 Aug 2023
- Last updated
- 12 Feb 2025
- 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 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Niacinamide a in the Management of Facial Post Inflammatory Hyperpigmentation (PIHP) Test Under Dermatological Control
- ClinicalTrials.gov ID
- NCT06822335
- Acronym / sponsor ID
- 2223CMCL076 _ LRP 22061
- Conditions
- Acne, Post-inflammatory Hyperpigmentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 7 Aug 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 12 Feb 2025 (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.
Double-blind, randomized, clinical study is designed to evaluate the efficacy of Niacinamide A in the management of facial Post Inflammatory Hyper Pigmentation (PIHP) in healthy female and male subjects with moderate to severe PIHP due to acne, mild acne and (≤4) inflammatory lesions, its impact on skin lightening effect and lastly any associated benefits on skin quality.
Detailed description
Primary objective To investigate the depigmenting effect of Niacinamide A in moderate to severe facial post inflammatory hyperpigmentation due to acne after a 12-week application period.
Secondary objectives
To evaluate any associated benefit of the product on skin condition and skin imperfection at different timepoints:
Product lightening efficacy using the Spectrocolorimeter. Evaluation of the global assessment evaluation for acne severity by the investigator using a 6 -point scale.
Counting of non-inflammatory and inflammatory lesions to access the change on the face.
Investigator scoring to assess the local intolerance (erythema, edema, dryness).
Subject scoring to assess the local intolerance(burning, stinging, itching and tingling sensations).
Subjective assessment of global tolerance of the product using a 4-point scale. Skin imaging analysis to assess the evaluation of the PIHP(darkness, size, number brown spots).
Evaluation of the mean darkness. Subjective evaluation of Global Assessment(SGA). Subject questionnaires to assess consumer perceived skin endpoints by filling in a cosmetic evaluation questionnaire and a stigmatization questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- female and male subjects with (Fitzpatrick phototype III-VI), aged between 18 and 50 years old, with moderate to severe PIHP due to acne (score PIHP > 10), with mild acne (GEA 2) and having inflammatory lesions (≤ 4 <10).
Key inclusion criteria (8 listed)
- Female and male subjects aged between 18 - 50 years old.
- Subject of Fitzpatrick phototype III-VI.
- Subject must be willing and be able to comply with the study schedule, procedures, and restrictions.
- Subjects with moderate to severe scores (4-8) on mean darkness intensity.
- Subjects with moderate to severe PIHP due to acne (score PAPHI>10).
Key exclusion criteria (20 listed)
- Pregnant or intending to become pregnant during the study or breastfeeding or in menopause.
- Subjects under any hormonal therapy, such as contraceptive pills or androgen agonist/antagonist medications, within the last 3 months before Visit 1 or planning to start any therapy during the study.
- Subject with cutaneous pathology on the studied zone other than acne (eczema etc.).
- Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the acceptability and efficacy of the studied products (according to the investigator's appreciation).
- Moderate to severe acne (GEA >2).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
POST ACNE HYPERPIGMENTATION INDEX (PAHPI)
Time frame: From baseline to Days 84
The scoring will be performed by the Investigator with the PAHPI at etch visites. The score is composed by 3 parameters: Median Lesion size with 4 grades ( <3mm, 3-6mm, 7-10mm, >10 mm) , intensity with 3 grades ( slightly darker, Moderate darker, significant darker) and number of PIHP lesions with5 grades ( 01-15 lesions, 16-30 lesions, 31-45 lesions, 46-60 lésions, >60 lesions . The global score will be calculated (6 to 22).
2 secondary outcomes
CLINICAL ASSESSMENT OF ACNE SEVERITY
Time frame: From baseline to Days 84
Subject Global Assessment
Time frame: From baseline to Days 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 12 Feb 2025.
- 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.
Gitanjali Gitanjali, MBBS, DDV principal investigator
CIDP Ltée
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 Post-inflammatory Hyperpigmentation, run by Cosmetique Active International at 1 site in Mauritius.
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 8 inclusion and 20 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 12 Feb 2025. 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 Mauritius. 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?
POST ACNE HYPERPIGMENTATION INDEX (PAHPI) (time frame: From baseline to Days 84). 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 12 Feb 2025.