Assessment of the effect of a topical 2.55 % PAP compared to its placebo on half-face treatment for 5 weeks with in healthy volunteers with oily skin

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2011/091/000084
• Date of registration: 18-01-2011
• Prospective Registration: Yes
• Primary sponsor: LOREAL RESEARCH
• Public title: Assessment of the effect of a topical 2.55 % PAP compared to its placebo on half-face treatment for 5 weeks with in healthy volunteers with oily skin
• Scientific title: 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
• Date of first enrolment: 31-01-2011
• Target sample size: 30
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=2604
• Study type: Interventional
• Study design: Other; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded
• Phase: Phase 2

Countries of recruitment

India, Mauritius

Contacts

• Name: Dr Sanjeev Miglani
• Affiliation: CIDP Biotech India Pvt. Ltd.

• Name: Rashi Nangia
• Affiliation: CIDP Biotech India Pvt. Ltd.

Key inclusion & exclusion 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.

Age minimum:
Age maximum:
Gender:

Intervention(s)

Intervention1: PAP gel: 2.55%
Control Intervention1: Placebo: gel without active

Primary Outcome(s)

-Facial skin appearance: with clinical scoring of skin oilyness (oily touch,shiny aspect and pores size, ..) done on days 1, 8, 15, 29, and 36,

- Photography scoring (in normal, cross polarized and parallel polarized light) of skin oiliness, and acne lesions on days 1, 8, 15, 29, and 36,

-Clinical evaluation and counting of cutaneous inflammatory/non inflammatory acne lesions on days 1, 8, 15, 29, and 36,

- Sebum rate on forehead and cheeks: with a Sebumeter® on days 1, 8, 15,29, and 36.Timepoint: days 1, 8, 15,29, and 36

Source(s) of Monetary Support

LOREAL RESEARCH, Centre Charles Zviak Advanced Clinical Research Discovery Department 90, Rue Du Général Roguet 92583 CLICHY Cedex - FRANCE

Secondary Sponsor(s)

CIDP Biotech India Pvt Ltd

Ethics review

Status: Approved
Approval date: 15/01/2011
Contact:

Norms Ethical Committee, Mangalore