Skip to main content
MedPathMedPath Home
Clinical Trials/CTRI/2011/091/000084
CTRI/2011/091/000084
Completed
Phase 2

Assessment of the efficacy of a 5-weeks randomized, controlled half-face treatment with topical 2.55 % PAP compared to its placebo in healthy volunteers with oily skin

OREAL RESEARCH0 sites30 target enrollmentTBD
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
OREAL RESEARCH
Enrollment
30
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
OREAL RESEARCH

Eligibility Criteria

Inclusion Criteria

  • •Healthy male volunteers, aged 18 \- 40 years,
  • •\- Skin phototype II\-V (Fitzpatrick classification),
  • •\- Presenting an oily skin appearance on the face (sebum rate \>150 mg/cm2 on the forehead right and left),
  • •\- Acne prone subjects showing the presence of facial acne (grade 2\-7 in the Leeds acne grade), presenting at least 15 inflammatory lesions and at least 25 non\-inflammatory lesions on the face,
  • •\- Able to give written informed consent and to comply with the requirements of the study.

Exclusion Criteria

  • •\-Females subjects,
  • •\- Any significant skin pathology in the test areas, like rosacea, severe acne,or eczema. (Subjects with mild to moderate acne will be acceptable provide the condition does not interfere with the objectives of the study),
  • •\- Known hypersensitivity to any of the study drugs or constituents,
  • •\- Any topical or systemic treatment that could interfere with the study treatments/assessments (topical benzoyl peroxide and other antiacne or antiseborreic products, antibiotics, corticosteroids, retinoids, antiinflammatory
  • •drugs?) within the last 4 weeks prior to participation in the study, and during the study,
  • •\- Any surgical treatment on the test areas (laser peel, dermabrasion, etc.),
  • •\- Subject reported or planning to sun\-bath or to overexpose to UV\-light (mountains sports, phototherapy, tanning salon use, etc.) for aesthetic or
  • •therapeutic reason the month before the study start or during the study,
  • •\- Any significant medical condition that would interfere in the participation in the trial,
  • •\- Participation in a clinical trial up to 1 month prior to inclusion.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Completed
Not Applicable
Study of effectiveness of a topical product benzoyl peroxide 2.5% and 5% gel in healthy volunteers with oily skin.
CTRI/2011/10/002080OREAL RESEARCH80
Completed
Not Applicable
Study of effectiveness of a gel (4% ER2412) compared to placebo in healthy volunteers with oily skin.
CTRI/2012/12/003176OREAL RESEARCH37
Completed
Not Applicable
Evaluation of the effectiveness of Neuro Psycho Physical Optimization with Conveyer of Modulating Radiance (CMR) in stress-related physical and mental effort.
ACTRN12607000497404Istituto Rinaldi Fontani720
Completed
Not Applicable
Evaluation of the effectiveness of Neuro Psycho Physical Optimization with Conveyer of Modulating Radiance (CMR) in stress-related hyperactivity and acceleration.Stress, Stress-related hyperactivity and accelleration.Mental Health - Other mental health disorders
ACTRN12607000502437Istituto Rinaldi Fontani869
Completed
Not Applicable
Evaluation of the effectiveness of Neuro Psycho Physical Optimization with Conveyer of Modulating Radiance (CMR) in stress-related loss of control and irritability.Stress-related loss of control and irritability.Mental Health - Other mental health disorders
ACTRN12607000487415Istituto Rinaldi Fontani700