A Single Centre, Open Label, Single Arm Pilot Study to Investigate on Safety and Efficacy of the Acne buster Lotion on Subjects with Mild to Moderate Acne Vulgaris on Face.

a. Primary objectives

·        To evaluate the safety by assessing site application reaction.

·        To evaluate the efficacy of acne buster lotion in reducing acne vulgaris of face by dermatological assessment with GAG scoring system and by imaging system.

·        To know the reduction in sebum by instrumental analysis with sebumeter

b. Secondary objective

·        To know safety and efficacy by subjects self assessment.

·        To gather information prior to a larger study, in order to improve the latter’s quality and efficiency of the study design.

Open- labeled ,prospective , monocentric, single arm pilot study

24 Subjects

·        Dermatologist’s assessments:

·        Imaging system- Image Pro II

·        Instrumental analysis

Acne buster lotion

Moisturizer

Sunscreen lotion

Face wash

Healthy subjects with mild to moderate acne vulgaris of face.    

Medical history, general physical examination and dermatological assessments

• Male and female subjects  between 18 to 40 years
• Subjects willing to give the voluntary written informed consent.
• Subjects having acne vulgaris on face with mild to moderate severity on GAG score
• Subjects willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.
• Subjects willing to abstain from using any other treatments for acne vulgaris.
• Subjects not having other skin diseases on facial skin such as allergic contact dermatitis, atopic dermatitis, tinea faciei, tinea barbae, nodulocystic acne, acne conglobata, rosacea and DLE/SLE
• Few lesions of asymptomatic pityriasis alba is acceptable.
• Subjects who uses make ups should be willing to continue the same brands of make-ups and should agree not to change make – up brands throughout the study period.
• Safe contraception.

• Subjects not willing to give voluntary informed consent and Subjects not able to come for the timely follow up
• Usage of any other medicinal products which can affect the course of the disease or the therapy
• Subjects with very severe acne on GAG score
• Secondary acne such as drug induced acne, chloracne,  acneiform eruptions (dermatitis), steroid induced acne and very severe acne such as  nodulocystic acne or acne conglobata, acne fulminans
• Subjects on other modalities of treatment for the acne (topical treatment <2 weeks, systemic treatment < 4 weeks)
• Systemic pre-treatment with isotretinoin within 3 months prior to enrolment
• Existence of a disease that demands systemic and/or topical – or steroid-administration
• Other associated uncontrolled systemic diseases such as diabetes mellitus, hypertension and other systemic diseases like renal functional abnormalities, liver abnormalities, tumors.
• Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold.
• Subjects who have undergone other dermatological procedures such as chemical peels, microdermabrasion, intralesional steroid injections, laser treatment 30 days prior to baseline.
• Alcohol or drug or medication abuse