Study of effectiveness of an essential oil mix (P798208 08) in healthy volunteers with oily skin.

Assessment of the efficacy of a 6-weeks randomized, controlled half-face treatment with topical formulae containing P798208 08 compared to its placebo in healthy volunteers with oily skin.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/07/001892

Enrollment

Registered

2011-07-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: A topical gel containing P798208 08: Mix of essential oils (P798208 08) containing mostly lemongrass and rosemary essential oils. Control Intervention1: Topical gel without active (plac

Eligibility

Inclusion criteria

Inclusion criteria: · Healthy male volunteers, aged 18 ? 40 years · Skin phototype II-V (Fitzpatrick) · Presenting an oily skin appearance on the face (sebum rate 70 μg/cm2 30 mn after degreasing 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

Exclusion criteria: · Females subjects, · Known hypersensitivity to any of the study drugs or constituents, · Any significant skin pathology in the test areas, like rosacea, severe acne, or eczema. Subjects with mild to moderate acne will be acceptable provided the condition does not interfere with the objectives of the study, · 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, ?), · Subject reported or planning to sun-bath or to overexpose to UV-light (mountains sports, phototherapy, tanning salon use?) 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.

Design outcomes

Primary

Measure	Time frame
efficacy of a compound on oily skin as determined by clinical and instrumental evaluations measuring the amount of sebum and its effect on acne formation.Timepoint: Day 1, 8, 15, 29, 36 and 43	—

Secondary

Measure	Time frame
safety and local tolerance of a formulae containing P798208 08 in facial cosmetic products.Timepoint: Days 1-43	—

Countries

India

Contacts

Public ContactRashi Nangia

CIDP Biotech India Pvt. Ltd.

smiglani@cidp-cro.com011-40793385

Outcome results