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 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 Â·        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