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Sunscreen Efficacy Against the Reccurence of Lesions Post-sun Exposure in Acneic Subjects

2021년 12월 7일 업데이트: Pierre Fabre Dermo Cosmetique

Evaluation of the Cutaneous and Ocular Tolerance of RV4857A Sunscreen Product and Its Efficacy Against the Recurrence of Lesions Post Sun Exposure in Subjects With Facial Acne

The aim of this study is firstly to assess the tolerance of the sunscreen RV4857A-CD2110 after 28 days and 57 days of at least a twice daily on the study areas, secondly to assess anti-imperfection efficacy after 28 days and 57 days of use and its efficacy against recurrence of acne lesions post-sun exposure.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

This is a monocentric study on adults and adolescents with acne prone skin on the face. This open-labelled study aim first to assess the dermatological and ophthalmological tolerance of the investigational sunscreen product RV4857A formula CD2110 after 28 days and, dermatological tolerance after 57 days of at least a twice daily on the study areas, under normal conditions of use, on 40 subjects intending to have a minimum of 10 days per month of sun exposure duration ≥ 1h, in the time slot 11am-4pm and intending to have a minimum of 4 swimming sessions (sea or swimming pool) during at least the first month of the study.

Secondary objectives :

  • To assess the anti-imperfection efficacy of the product during the summer
  • To assess the "non" rebound effect (non recurrence of acne) one month after stopping the application of the sunscreen and without any sun exposure at D85 (difference between D85 and D0)
  • To evaluate the impact on Quality of Life of subjects through CADI and DLQI questionnaires (or CDLQI questionnaire for adolescent from 12 to 16 years-old) completed at baseline, D29 and D57

The study includes 4 visits :

  • Visit 1: Inclusion visit (D1)
  • Visit 2: Intermediate visit (D29)
  • Visit 3: Intermediate visit "end of summer" (D57), a Stop the application of the sunscreen product (and stop sun exposure) between Visit 3 and the end of the study Visit 4: End of study visit in autumn (D85)

The theoretical study duration for each subject will be 85 days with at least 57 days of product use. The study interest areas are Face and Neck.

연구 유형

관찰

등록 (실제)

45

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

12년 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

샘플링 방법

확률 샘플

연구 인구

Subjects will be recruited from the investigation centre's panel. The participants will be selected on the basis of inclusion and non-inclusion criteria specific to the study and on their ability to comply with the constraints required by the protocol. The participants will be definitely included in the study after a specific interview and a clinical examination

설명

Inclusion Criteria:

  1. Related to the population:

    • Females and/or males (with at least 25% of male)
    • Age: adults from 18 to 40 years old and adolescent from 12 to 17 years old (33% to 50% of the total population)
    • Considered "healthy subject" by the Investigator
    • Being of Phototype I to IV
    • Subject with combination to oily skin
    • Subject who foresees sun exposure during the first 2 months of the study
    • Subjects must be registered with health social security or health social insurance (if required by national regulations)
    • Subject and/or parent(s)/legal representative(s) who have signed his/her/their written informed consent for his/her participation in the study (or his/her/their child participation in the study) and a photograph authorization
    • For woman of childbearing potential: committing herself to use effective contraceptive method since at least 3 months before the beginning of the study and committing to it throughout the study
    • Regular users of very high protection sunscreen products.

  2. Related to the disease:

    • For adults and adolescents: subject with mild to moderate acne with a total of 10 to 40 acne lesions (at least 5 non-inflammatory lesions (open and closed comedones) and at least 3 to 10 inflammatory lesions (papules and pustules) maximum on the face, excluding the nose area), at the inclusion.
    • Subject prone to have recurrence of acne lesions in autumn (declarative)

Exclusion Criteria:

  1. Related to the population:

    • Having participated in another clinical trial within 4 weeks before the inclusion visit and for a longer period if required in the Investigator's opinion Taking part or planning to participate in another clinical trial during the study in the same or another investigation centre
    • Breastfeeding or pregnant or not willing to take necessary precautions to avoid pregnancy during the study and for at least 3 months before the inclusion visit (for the woman of childbearing potential)
    • Subject or parent(s)/legal representative(s) deprived of freedom by administrative or legal decision or under guardianship
    • Subject or parent(s)/legal representative(s) not able to be contacted in case of emergency
    • Subject admitted in a sanitary or social facility
    • Subject planning a hospitalization during the study

  2. Related to the disease

    • Cutaneous pathology (psoriasis, atopic dermatitis, skin infectious disease of viral, bacterial, fungus or parasitic origin …) or dermatological condition (especially pityriasis versicolor, severe pigmentation disorders) on the studied zone other than acne liable to interfere with the data of the study
    • Severe acne
    • Clinical signs of hormonal disfunctions or hyperandrogenism
    • Excessive exposure to sunlight or UV-rays within the previous month
    • Having history of abnormal reactions from exposure to sunlight
    • Use of self tanning product during the previous month History of hypersensitivity or intolerance to any cosmetic product

  3. Related to treatments

    • Use of a systemic or topical medication with anti-inflammatory or photosensitising products during the previous 2 weeks and for systemic medication with corticoids and/or antihistaminics during the previous 4 weeks
    • Use of a systemic treatment for acne during the previous month for antibiotics, zinc gluconate and hormonal treatment and during the 6 previous months for isotretinoin
    • Use of a topical treatment for acne during the previous month (benzoil peroxide, retinoid, antibiotics, azelaic acid…)
    • Use of anti-acneic or anti-seborrheic cosmestic care (containing alpha hydroxy-acids, retinoic derivatives..) during the 15 previous days
    • Use of other topical or systemic treatment during the previous weeks liable to interfere with the assessment of the cutaneous tolerance and efficacy of the studied product (according to the investigator's appreciation)
    • Any surgery, chemical or physical treatment on the experimental area within the 12 months prior to the study or foreseeing it for the duration of the study
    • Woman whose oral contraception is instaured or changed for less than 3 months

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
RV4857A arm

Application of the product before and during each sun exposure, at least twice a day.

During sun exposures, the applications were renewed as often as necessary, in particular after swimming, perspiring, towelling, in order to ensure a good protection. On days of bad weather, the product was applied in the morning and at the beginning of the afternoon.
다른: RV4857A
RV4857A formula CD2110 is a sunscreen product

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Assessment of the dermatological physical signs
기간: Change from Baseline to 30 minutes after product application, to 29 and 57 days later
The assessment of the dermatological physical signs is based on a visual examination
Change from Baseline to 30 minutes after product application, to 29 and 57 days later
Assessment of the dermatological functional signs
기간: Change from Baseline to 30 minutes after product application, to 29 and 57 days later
The functional signs is assessed by questioning the subject
Change from Baseline to 30 minutes after product application, to 29 and 57 days later
Assessment of the ophthalmological physical signs
기간: Change from Baseline to 30 minutes after product application, to 29 and 57 days later
The assessment of the ophthalmological physical signs is based on a dermatologist visual examination
Change from Baseline to 30 minutes after product application, to 29 and 57 days later
Assessment of the ophthalmological functional signs
기간: Change from Baseline to 30 minutes after product application, to 29 and 57 days later
The functional signs is assessed by questioning the subject
Change from Baseline to 30 minutes after product application, to 29 and 57 days later
Assessment of the Tear film Break Up Time (BUT)
기간: Change from Baseline to 30 minutes after product application, to 29 and 57 days later
The tear film break-up time is a test to measure the relative stability of the pre-corneal tear film. This examination is performed by the same Ophthalmologist thanks to a biomicroscope after blinking (using a chronometer). The measured time will be expressed in seconds
Change from Baseline to 30 minutes after product application, to 29 and 57 days later
Assessment of global tolerance assessment (dermatogical assesment), a 5-point scale
기간: Change from Baseline to 29 and 57 days later
  • Excellent: no functional nor physical signs related to the investigational product observed or reported by the subjects
  • Very good
  • Good
  • Moderate
  • Bad
Change from Baseline to 29 and 57 days later
Assessment of global tolerance assessment (ophthalmological assessment), a 5-point scale
기간: Change from Baseline to 29 days later
  • Excellent: no functional nor physical signs related to the investigational product observed or reported by the subjects
  • Very good
  • Good
  • Moderate
  • Bad
Change from Baseline to 29 days later

2차 결과 측정

결과 측정
측정값 설명
기간
Change of the number of total acne lesions on the face
기간: Change from Baseline to 29, 57 and 85 days later
by counting according to the method of Lucky
Change from Baseline to 29, 57 and 85 days later
Change of the number of non-inflammatory lesions (open and closed comedones) on the face
기간: Change from Baseline to 29, 57 and 85 days later
by counting according to the method of Lucky
Change from Baseline to 29, 57 and 85 days later
Change of the number of inflammatory lesions (papules, pustules, nodules) on the face
기간: Change from Baseline to 29, 57 and 85 days later
by counting according to the method of Lucky
Change from Baseline to 29, 57 and 85 days later
Assessment of the non-comedogenic potential
기간: Change from Baseline to 29 days later
by statistical comparison of open and closed comedones counted by the investigator on the face before and after 28 days of application of investigational product
Change from Baseline to 29 days later
Change of the acne severity, assess by Global Acne Evaluation (GEA) on a 6-point scale
기간: Change from Baseline to 29, 57 and 85 days later
  • 0: Clear
  • 1: Almost clear
  • 2: Mild
  • 3: Moderate
  • 4: Severe
  • 5 : Very Severe
Change from Baseline to 29, 57 and 85 days later
Evaluation of the global acne evolution on a 6-point scale
기간: Change from Baseline to 29 and 57 days later

-1: Worsening, 0: No change,

  1. Mild improvement,
  2. Moderate improvement,
  3. Good improvement,
  4. Very good improvement
Change from Baseline to 29 and 57 days later
Evaluation of the global product efficacy by the subjects themselves regarding rebound effect in Autumn
기간: Change from Baseline to 85 days later
Questions Q24 and Q25 at D85 in the self-questionnaire
Change from Baseline to 85 days later
Assessment of the cosmetic acceptability and perceived efficacy of the product
기간: Change from Baseline to 29 and 57 days later
The self subject assemsment consists of different questions concerning participants' perception of the product's efficacy (majority of scales ranging from 0 to 10 where 0 was the worst satisfaction and 10 the best one)
Change from Baseline to 29 and 57 days later
To evaluate the impact on Quality of Life of subjects through questionnaires
기간: Change from Baseline to 29 and 57 days later
Quality of Life questionnaires consist of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week
Change from Baseline to 29 and 57 days later

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Pierre Fabre Dermo Cosmetique

수사관

  • 연구 의자: Pedro Contreiras Pinto, PhD, PhD Trials®
  • 수석 연구원: Leonor Girão, MD, PhD Trials®

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2020년 7월 16일

기본 완료 (실제)

2020년 11월 9일

연구 완료 (실제)

2020년 11월 9일

연구 등록 날짜

최초 제출

2021년 9월 29일

QC 기준을 충족하는 최초 제출

2021년 12월 7일

처음 게시됨 (실제)

2021년 12월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 12월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 12월 7일

마지막으로 확인됨

2021년 12월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • RV4857A202092

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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