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CompletedNCT05601960Updated Nov 1, 2022

A Combination Treatment Reduces Acne Severity and PIHP

An observational study in Acne and Postinflammatory Hyperpigmentation, sponsored by Cosmetique Active International. Completed at 1 site in United Arab Emirates. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-01.

Sponsored by Cosmetique Active International · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,785
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Acne
  • Postinflammatory Hyperpigmentation

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In context

Hyperpigmentation

102 studies on the registry are indexed under Hyperpigmentation; 20 are open to participants now.

This study's enrollment of 1,785 is above the median of 80 across 11 observational studies indexed under Hyperpigmentation.

Browse Hyperpigmentation studies →

Lead sponsor

Cosmetique Active International is the lead sponsor of 54 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Adult subjects with mild to moderate acne, post-inflammatory hyperpigmentation and of any phototype were suitable for this study.

Inclusion criteria

  • adult
  • mild to moderate acne
  • presence of postinflammatory hyperpigmentation lesions
  • phototype IV to VI

Exclusion criteria

Exclusion Criteria:

  • less than 18 years
  • severe acne
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,785 participants (actual)
Target follow-up
1 Year
Patient registry
Yes

Interventions

  • Otheranti-acne dermocosmetic

    Topical application once daily for 2 months

    Also known as: Sun screen

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What researchers measure

Primary outcomes

  1. seborrhoea level

    visual analog scale scale 0=none to 10= very severe

    Time frame: baseline

  2. seborrhoea level

    visual analog scale 0=none to 10= very severe

    Time frame: Month 2

  3. acne severity

    GEA (Global evaluation of acne) scale 0=none to 5=very severe

    Time frame: baseline

  4. acne severity

    GEA (Global evaluation of acne) scale 0=none to 5=very severe

    Time frame: Month 2

  5. PAHPI: post-acne hyperpigmentation index

    post-acne hyperpigmentation index from \<3mm to \>10mm

    Time frame: baseline

  6. PAHPI: post-acne hyperpigmentation index

    post-acne hyperpigmentation index from \<3mm to \>10mm

    Time frame: Month 2

  7. inflammatory lesions

    lesion count

    Time frame: baseline

  8. inflammatory lesions

    lesion count

    Time frame: Month 2

  9. non-inflammatory lesions

    lesion count

    Time frame: baseline

  10. non-inflammatory lesions

    lesion count

    Time frame: Month 2

Secondary outcomes

  1. Investigator satisfaction acne

    visual analog scale from very unsatified=0 to very satisfied=5

    Time frame: Month 2

  2. Investigator satisfaction

    visual analog scale from very unsatified=0 to very satisfied=5

    Time frame: Month 2

  3. Patient satisfaction acne

    visual analog scale from very unsatified=0 to very satisfied=5

    Time frame: Month 2

  4. Patient satisfaction PAHPI

    visual analog scale from very unsatified=0 to very satisfied=5

    Time frame: Month 2

  5. Patient: Skin quality

    visual analog scale from very unsatified=0 to very satisfied=5

    Time frame: Month 2

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Study locations

1 site
  • L'Oreal
    Dubai, United Arab Emirates
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05601960
Lead sponsor
Cosmetique Active International
Responsible party
Sponsor
First posted
Nov 1, 2022
Start date
Apr 15, 2020
Primary completion
Feb 28, 2021
Completion
Feb 28, 2021
Last update
Nov 1, 2022

Study contacts

Rana Shabab
principal investigator · Dermatique Skin Care, Khobar, KSA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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