None listed
Conditions
Interventions
Intervention1: Acne buster lotion: Investigational product should be applied by the subject twice a day i.e., morning (7am to 9 am) and evening 56 days (8 weeks) for each volunteer
Control Interventio
Sponsors
ICHIMARU PHARCOS CO Ltd
Eligibility
Inclusion criteria
Inclusion criteria: • 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 â?? up brands throughout the stud period. • Safe contraception
Exclusion criteria
Exclusion criteria: • 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 • Systemic pre-treatment with isotretinoin within 3 months prior to enrolment • Existence of a disease that demands systemic and/or topical â?? 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ To evaluate the safety by assessing site application reaction. â?¢ 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. â?¢ To know the reduction in sebum by instrumental analysis with sebumeterTimepoint: Day 28, Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Mukta Sachdev
MS Clinial Research Pvt Ltd
Outcome results
None listed