| CTRI Number |
CTRI/2011/07/001892 [Registered on: 15/07/2011] Trial Registered Retrospectively |
| Last Modified On: |
17/10/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Other |
|
Public Title of Study
|
Study of effectiveness of an essential oil mix (P798208 08) in healthy volunteers with oily skin. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ACR/DELO/1108 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sah Gaurang Krishna |
| Designation |
Principal Investigator (MBBS, MD Dermatology) |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
3rd Floor, Max Medcentre, N-110, Panschsheel Park, New Delhi
New Delhi DELHI 110017 India |
| Phone |
01140793385 |
| Fax |
01140793386 |
| Email |
gaurangkrishna3@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sanjeev Miglani |
| Designation |
COO and Scientific Director |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
CIDP Biotech India Pvt. Ltd.,
3rd Floor, Max Medcentre, N-110, Panschsheel Park, New Delhi
New Delhi DELHI 110017 India |
| Phone |
011-40793385 |
| Fax |
011-40793386 |
| Email |
smiglani@cidp-cro.com |
|
Details of Contact Person Public Query
|
| Name |
Rashi Nangia |
| Designation |
QA Manager |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
CIDP Biotech India Pvt. Ltd.,
3rd Floor, Max Medcentre, N-110, Panschsheel Park, New Delhi
New Delhi DELHI 110017 India |
| Phone |
01140793385 |
| Fax |
01140793386 |
| Email |
rnangia@cidp-cro.com |
|
|
Source of Monetary or Material Support
|
| LOREAL RESEARCH, Centre Charles Zviak Advanced Clinical Research Discovery Department 90, rue du Général Roguet 92583 CLICHY Cedex - FRANCE |
|
|
Primary Sponsor
|
| Name |
LOREAL RESEARCH |
| Address |
Centre Charles Zviak Advanced Clinical Research Discovery Department 90, rue du Général Roguet 92583 CLICHY Cedex - FRANCE |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sah Gaurang Krishna |
CIDP Biotech India Pvt. Ltd. |
3rd Floor, Max Medcentre, N-110, Panchsheel Park, New Delhi New Delhi DELHI |
011-40793385 011-40793386 gaurangkrishna3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ALERT EC-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy human volunteers with oily skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A topical gel containing P798208 08 |
Mix of essential oils (P798208 08) containing
mostly lemongrass and rosemary essential oils. |
| Comparator Agent |
Topical gel without active (placebo). |
Vehicle of P798208 08 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
· 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. |
|
| ExclusionCriteria |
| Details |
· 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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
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. |
Day 1, 8, 15, 29, 36 and 43 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| safety and local tolerance of a formulae containing P798208 08 in facial cosmetic products. |
Days 1-43 |
|
|
Target Sample Size
|
Total Sample Size="37" Sample Size from India="37"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
13/07/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="2" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study will be monocentric, comparative, placebo controlled, double-blinded and randomized half-face application out patient study. The study objectives are (1) To assess the 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 and (2) to assess the safety and local tolerance of a formulae containing P798208 08 in facial cosmetic products. The study rationale is to evaluate the effect of a mix of essential oils (P798208 08) containing mostly lemongrass and rosemary essential oils. This active mix is expected to reduce p.acnes, inflammation and stimulate the exfoliation process that will reduce sebum secretion and acne formation. Topical application (on the face) will be done once a day on dried skin from study days D1 to D42. The subjects will receive a topical gel containing P798208 08 on one half face, and corresponding vehicle on the other half of the face according to a pre-determined randomization list. The subject study period is 6 weeks and study duration is 8 weeks. The study will be conducted in healthy human male volunteers (age 18-40 yrs) with oily skin. Thirty seven subjects will be enrolled to ensure that at least thirty two randomized subjects complete the study procedures. |