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OpenTrials
Completed

NCT Number: NCT05601960

A Combination Treatment Reduces Acne Severity and PIHP

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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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Hyperpigmentation Pigmentation Disorders Postinflammatory Hyperpigmentation Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

L'Oreal

Dubai, United Arab Emirates

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • less than 18 years
  • severe acne

Treatment and study plan

anti-acne dermocosmetic

Other

Topical application once daily for 2 months

Other names: Sun screen

Primary outcomes

  1. seborrhoea level

    Time frame: baseline

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

  2. seborrhoea level

    Time frame: Month 2

    visual analog scale 0=none to 10= very severe

  3. acne severity

    Time frame: baseline

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

  4. acne severity

    Time frame: Month 2

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

  5. PAHPI: post-acne hyperpigmentation index

    Time frame: baseline

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

  6. PAHPI: post-acne hyperpigmentation index

    Time frame: Month 2

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

  7. inflammatory lesions

    Time frame: baseline

    lesion count

  8. inflammatory lesions

    Time frame: Month 2

    lesion count

  9. non-inflammatory lesions

    Time frame: baseline

    lesion count

  10. non-inflammatory lesions

    Time frame: Month 2

    lesion count

Secondary outcomes

  1. Investigator satisfaction acne

    Time frame: Month 2

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

  2. Investigator satisfaction

    Time frame: Month 2

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

  3. Patient satisfaction acne

    Time frame: Month 2

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

  4. Patient satisfaction PAHPI

    Time frame: Month 2

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

  5. Patient: Skin quality

    Time frame: Month 2

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

Sponsors and collaborators

Lead sponsor

Cosmetique Active International

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 1, 2022
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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