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Completed

NCT Number: NCT05584150

The Benefit of a Deep Cleansing Gel in the Management of Mild to Moderate Truncal Acne

Acne vulgaris is a chronic inflammatory disease, mainly of the face, but also of the trunk. Acne may be caused by internal and external factors. Only a very small amount of data exists concerning truncal acne. The condition affects about 9% of the population worldwide, with 50% of subjects with facial acne also presenting with truncal acne. Until recently, clinicians frequently followed the same therapeutic approach as for facial acne, with treatment adherence remaining an issue.

This study assessed assessed the benefit of a cleansing gel containing salicylic acid 2%, zinc gluconate 0.2% and Lipo hydroxy acids (LHA) 0.05%, used daily for 84 days in mild to moderate truncal acne.

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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CIDP

Rio de Janeiro, 20231-048, Brazil

About this study

For this single center, open label, non-randomized exploratory study, 51 subjects with mild to moderate truncal acne were recruited. The study received ethics committee approval. All subjects provided written informed consent. The investigator evaluated the number of inflammatory, non-inflammatory and total lesions at Baseline, Day 42 and 84. Skin barrier function was appraised via the assessment of transepidermal water loss (TEWL) using a Tewameter® (Courage + Khazaka Electronic GmbH, Germany). Safety was assessed by considering the evaluation of clinical signs and reporting of symptoms, and local adverse reactions. Subjects were asked to gently massage the wet skin of the trunk with the product in the morning and evening for at least 30 seconds, and then thoroughly rinse with tempered water and pat dry.

Who can participate

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

Inclusion criteria

  • above 18 years
  • truncal acne

Exclusion criteria

  • None

Treatment and study plan

Deep Cleansing Gel

Other

daily use

Primary outcomes

  1. Investigator global assessment

    Time frame: baseline

    Scale 0=absent to 5=very serious

  2. Investigator global assessment

    Time frame: Day 42

    Scale 0=absent to 5=very serious

  3. Investigator global assessment

    Time frame: Day 84

    Scale 0=absent to 5=very serious

Secondary outcomes

  1. inflammatory lesion count

    Time frame: baseline

    count and percentage reduction

  2. inflammatory lesion count

    Time frame: Day 42

    count and percentage reduction

  3. inflammatory lesion count

    Time frame: Day 84

    count and percentage reduction

  4. non-inflammatory lesion count

    Time frame: baseline

    count and percentage reduction

  5. non-inflammatory lesion count

    Time frame: Day 42

    count and percentage reduction

  6. non-inflammatory lesion count

    Time frame: Day 84

    count and percentage reduction

  7. total lesion count

    Time frame: baseline

    count and percentage reduction

  8. total lesion count

    Time frame: Day 42

    count and percentage reduction

  9. total lesion count

    Time frame: Day 84

    count and percentage reduction

  10. acne severity

    Time frame: baseline

    scale 0=absent to 5=very severe

  11. acne severity

    Time frame: Day 42

    scale 0=absent to 5=very severe

  12. acne severity

    Time frame: Day 84

    scale 0=absent to 5=very severe

  13. transepidermal water loss

    Time frame: baseline

    tewameter assessment

  14. transepidermal water loss

    Time frame: Day 42

    tewameter assessment

  15. transepidermal water loss

    Time frame: Day 84

    tewameter assessment

  16. clinical safety

    Time frame: baseline

    assessment of clinical signs symptoms and adverse events

  17. clinical safety

    Time frame: Day 42

    assessment of clinical signs symptoms and adverse events

  18. clinical safety

    Time frame: Day 84

    assessment of clinical signs symptoms and adverse events

  19. subject efficacy perception

    Time frame: Day 42

    scale 0=none to 5= very good

  20. subject efficacy perception

    Time frame: Day 84

    scale 0=none to 5= very good

  21. subject product perception

    Time frame: Day 84

    sacle 0=bad to 5 very good

Sponsors and collaborators

Lead sponsor

Cosmetique Active International

Industry

Registry information

Official study title

Assessment of the Benefit of a Deep Cleansing Gel Containing Salicylic Acid 2%, Zinc Gluconate 0.2% and Lipohydroxy Acids 0.05% in Patients With Mild to Moderate Truncal Acne: Results From an Exploratory Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 18, 2022
Registry last updated
Oct 18, 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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