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Completed

NCT Number: NCT05469880

Efficacy and Tolerance of Formula 609613 37 in Acneic Patients

Acne affects most adolescents and young adults with varying severity and presentation. For early or localized forms, the first-line treatment is usually local. The available treatments often lead to local irritation, particularly during the first few weeks of use. This is why creams containing exfoliating agents have long been used in acne, as they are considered to allow a faster disappearance of superficial lesions.

The objective of this 6-month double-blind study is to demonstrate in 100 acneic patients the interest of an anti-acne face cream as an adjunct to and in addition to a 5% benzoyl peroxide gel.

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Key information

Conditions

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

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The study is conducted in accordance with the protocol and the legislative and regulatory provisions in force (after obtaining authorization of the French health authorities and the favorable opinion of the ethics committee).

Regarding the statistical analysis, two different analysis are performed:

  • Descriptive analysis: quantitative variables are described by the mean and standard deviation and qualitative variables by the raw number of each modality and the corresponding percentage.
  • Comparative analysis: for quantitative variables, inter-group comparisons are made by a Student's T-test or a non parametric Mann-Whitney test if necessary. For qualitative variables, comparisons are made using a Chi-square test, if the expected number of participants is less than 5, Fischer's exact test on a 4-box contingency tables is used.

A significant level of p <0.05 is considered as significant. A double-data entry is carried out then a comparison of the two databases is performed. Finally internal and external consistency tests are planned. Missing data are described and possibly analyzed.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • acneic facial skin
  • between 20 and 50 non-inflammatory lesions on the face
  • between 10 and 40 superficial inflammatory lesions on the face
  • no local acneic treatment in the previous 15 days
  • no treatment with isotretinoin in the previous 3 months
  • agreeing to apply only the study products

Exclusion criteria

  • less than 20 or more than 50 non-inflammatory lesions on the face
  • less than 10 or more than 40 superficial inflammatory lesions on the face
  • prescription of a local acne treatment for less than 15 days
  • prescription of an antibiotic treatment for less than 1 month
  • prescription of an isotretinoin treatment for less than 3 months
  • changing toiletries and hygiene products regularly

Treatment and study plan

moisturizing cream and 5% benzoyl peroxide gel

Other

Group A: Eclaran 5% every evening and formula 609567 49 every morning, for 3 months.

Then the group is divided: Group A1/ formula 609613 37 and Group A2/ formula 609567 49 every morning, for the next 3 months

anti-acne face cream and 5% benzoyl peroxide gel

Other

Group B: Eclaran 5% every other night and 609613 37 every morning, for 3 months.

Then the group is divided: Group B1/ 609613 37 and Group B2/ formula 609567 49 every morning, for the next 3 months

Primary outcomes

  1. change in the composite score

    Time frame: from baseline to month 6

    the investigator evaluates i) the skin sensitivity (erythema, desquamation) and ii) the global tolerance on a 4-point scale (i) from Absent to Important and ii) from Nil to Excellent)

Secondary outcomes

  1. change in the lesion count

    Time frame: from baseline to month 6

    counting of non-inflammatory (open and closed comedones) and inflammatory (papules, pustules) lesions

  2. change in the evaluation of skin sensitivity by the patient

    Time frame: from baseline to month 6

    evaluation of the skin sensitivity (pruritus, tingling sensation, burning sensation) on a 4-point scale (from Absent to Important)

  3. change in the evaluation of global tolerance by the patient

    Time frame: from baseline to month 6

    evaluation on a 4-point scale (from Nil to Excellent)

  4. change in the evaluation of the efficacy by the investigator and patient

    Time frame: from baseline to month 6

    evaluation on a 4-point scale (from Nil to Excellent)

  5. change in the evaluation of the global efficacy by the investigator

    Time frame: from baseline to month 6

    evaluation on a 6-point scale (from No lesion to Very severe)

  6. change in the quality of life

    Time frame: from baseline to month 6

    evaluation of the quality of life of patients with the Cardiff Acne Disability Index (CADI) score

Sponsors and collaborators

Lead sponsor

Cosmetique Active International

Industry

Registry information

Official study title

Evaluation of the Efficacy and Tolerance of Formula 609613 37 in Acneic Patients as an Adjunct to and in Addition to 5% Benzoyl Peroxide for 6 Months

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 22, 2022
Registry last updated
Jul 22, 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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