Efficacy evaluation of cosmetic formulations in conferring dark spot reduction, wrinkle reduction and enhanced skin even tone in healthy human volunteers                       

Primary objectives:

§  To study the efficacy of investigational products in reducing hyper pigmentation spots in terms of intensity, size and number in comparison to baseline.

§  To study the efficacy of investigational products in reducing hyper pigmentation spots in terms of intensity, size and number in comparison to each other.

§  To study the efficacy of investigational products in reducing wrinkle in comparison to baseline.

§  To study the efficacy of investigational products in reducing wrinkle in comparison to each other.

Secondary objectives:

§  To study the efficacy of investigational products in enhancing evenness of skin tone in comparison to baseline.

§  To study the efficacy of investigational products in enhancing evenness of skin tone in comparison to each other.

Double blind, parallel design, comparative, controlled, single centre trial.

Total 160 healthy human male and female adult subjects.                                                                35+5 subjects in each of the 4 treatment groups.

Instrumental measurements- Visioscan (SEsw, SEsm), Photography/ Image Pro

Dermatologist’s visual assessment of varied skin attributes

Subject’s self assessment of varied skin attributes

CSWRS – A        CSWRS – B       CSWRS – C       CSWRS – D 

Totally 160 healthy human adult, male and female volunteers, in the age group of 18-55 yrs, representing varied skin types.

80 subjects having at least 2 and preferably more than 4 post inflammatory hyperpigmentation spots on face.

80 subjects having at least 2 and preferably more than 4 prominent wrinkles on crow’s feet area. 

General physical examination, medical history of subjects and skin sensitivity test

·   Subject willing to give a written informed consent and come for regular observations

·   Subject is a healthy adult, male or female, in the age range of 18 and 55 years

·   Subject has at least 2 and preferably more than 4-5 prominent wrinkles on crow feet area 

·   Subject has at least 2 and preferably more than 4-5 hyperpigmentary spots on face that are freckles, age spots, post inflammatory hyperpigmentation spots like post acne marks, Sebhorreic dermatitis, etc on face  

·   Subject has not participated in a similar clinical investigation in the past three months.

·   Subject who is willing to abstain from using any fairness product, sunscreens, natural/ ayurvedic treatments or other home remedies and also willing to abstain from undergoing any facial treatments such as facial masks, packs, bleaching, etc either at home or at parlour during the entire study course.

In case of having used fairness product in the near past, should be willing to undergo a wash out period of 1 week, wherein they should abstain from applying any product other than the provided cleanser on face.

·   Male subjects who are willing to maintain their facial skin condition as shaved at baseline and during the entire study course.

·   Subject who shows no skin sensitivity symptoms to the investigational products during the skin sensitivity test.

·   Female subjects of reproductive age group should undergo UPT at time of screening visit.

·   Subject with a known history or present condition of allergic response to any cosmetic/pharmaceutical products, toiletries or their ingredients including fragrance.

·   Subject who has used any systemic medication (antibiotics, oral contraceptive pills, retinoids, steroids, spironolactone or any anti acne medication) within past 4 weeks or any topical facial medication within 2 weeks prior to study commencement, which could compromise the study.

·   Subject with a medical history of disease or condition or a concurrent illness or pre-existing or dormant dermatologic condition (psoriasis, rosacea, rashes, eczema etc.) that could interfere with the study results.

·   Subject with excessive facial hair or scars, which could interfere with evaluation.

·   Subject with a history of having used a similar product during or since 1 week prior to the scheduled study commencement.

·   Subject who is currently pregnant (as confirmed by the urine pregnancy test) or nursing or contemplating pregnancy during the study course.

·   Subjects viewed by the investigator as not being able to complete the study.

6 weeks from evaluation commencement of each subject

General Physical and Dermatologist’s examination will be done at the screening, during the evaluation and post evaluation.

Subject’s discretion: A subject may voluntarily withdraw from the study at any time, citing the reason to the investigator without loss of any benefit that he or she may be otherwise entitled to. Investigators will share all information regarding the study that may possibly affect the subject’s willingness to participate in the trial.

Investigator’s discretion: Investigator may discontinue a subject’s participation from the study in case of the following events-

·      Non-compliance to the study restrictions and protocol

·      Possible threat to subject’s safety, health or study results

·      Development of hypersensitivity to test product or any other intolerable adverse event due to participation in the study as determined by the investigator or subject

·      Development of disease or illness by the subject rendering them unsuitable to participate in the study

·      Discovery that the subject entered the study in violation of the protocol or occurrence of a significant protocol violation during the study

·      Misbehavior that could affect other subjects or investigators

·      Mis-conduct that could affect the smooth operation of the study