FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 
 
Close