Clindamycin Phosphate Topical Lotion Eq. 1% Base among subjects with Acne.
- Conditions
- Health Condition 1: L700- Acne vulgaris
- Registration Number
- CTRI/2019/07/020128
- Lead Sponsor
- Encube Ethicals Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 915
A subject should fulfill all the following criteria to be included in the present
study:
1) Male or non-pregnant, non-lactating female aged >=12 and <=40 years with a clinical diagnosis of acne vulgaris.
2) On the face, >= 25 non-inflammatory lesions (i.e., open and closed comedones) AND >=20 inflammatory lesions (i.e., papules and pustules) AND <= 2 nodulocystic lesions (i.e. nodules and cysts).
3) Investigatorâ??s Global Assessment (IGA) of acne severity grade 2, 3 or 4.
4) Willing to provide written informed consent for participation in the study and having ability to comprehend the nature and purpose of the study.
In case of subject with age <18 years, legally acceptable representatives (LAR; e.g. parent/guardian/care-taker) must provide consent and Written Assent Form will be taken from subjects if they are able to comprehend the nature of the study.
Subject must be literate for inclusion in the study.
5) Willing to be available for the entire study period and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures, including anticipated ability to follow instructions for IP application and related usage, as per study protocol.
In case of children or among individuals not been able to follow instructions for IP application and related usage themselves, LAR (e.g. parent/guardian/care-taker) will be responsible for compliance of IP application and its related usage.
6) Willing to refrain from use of all other topical acne medications or antibiotics (other than study treatment) during the 12-week treatment period.
7) Subject not living in the same household as currently enrolled subjects (Other member of same house can be enrolled in the study, if current enrolled subject have completed the study).
8) In case of male subjects:
a) Subjects either abstain from sexual intercourse or who are willing to use adequate contraception (e.g. Use of condoms with or without spermicide ) during sexual intercourse with female partners of child bearing potential from screening day till 7 days after last dose of the study.
In case of female subjects:
a) Negative urine pregnancy test during screening and subsequent visits.
b) Subjects with child bearing potential or those within their first two years of onset of menopausal syndrome must either abstain from sexual intercourse, or must be willing to use acceptable methods of birth control from screening day till 7 days after last dose of the study.
(Reliable/acceptable birth control methods include barrier methods such as diaphragm/condom with or without spermicide or who are surgically sterile (bilateral tubal ligation, bilateral salpingectomy, bilateral oophorectomy or hysterectomy has been performed), or hormonal contraceptive
(oral, implant, injectable, or transdermal contraceptives) or abstinence practice).
Willing to maintain constant any estrogen or oral contraceptive therapy during the 12-week treatment period.
A subject fulfilling any one of the following criteria should be excluded from the study:
1) Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
2) Subjects who have acne conglobata, acne fulminans, nodulocystic acne and secondary acne (e.g.: chloracne and drug induced acne).
3) Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. Well-trimmed moustaches are allowed.
4) History of hypersensitivity or allergy to Clindamycin or Lincomycin and/or any of the study medication ingredients.
5) History of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.
6) Use within 6 months prior to baseline of oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
7) Use for less than 3 months prior to baseline of estrogens or oral contraceptives; use of such therapy is allowed if it will remain constant throughout the study. Use of hormonal contraceptives should not be initiated or changed during the study.
8) Use on the face within 1 month prior to baseline of: 1) cryodestruction or chemodestruction, 2) dermabrasion / microdermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, 6) X-ray therapy, or 7) chemical or laser peel.
9) Use within 1 month prior to baseline of: 1) Spironolactone, 2) systemic steroids, 3) systemic (e.g. oral or injectable) antibiotics, 4) systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), or 5) systemic anti-inflammatory agents.
10) Use within 2 weeks prior to baseline of: 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, 5) medicated cleansers/shampoo or 6) topical antibiotics.
11) Use of neuromuscular blocking agents within 14 days prior to baseline.
12) Use of astringents and toners for less than 2 weeks prior to the start of the study. The subject must have had an established regimen for at least 2 weeks prior to enrolment and must not have anticipated changing their regimen during the conduct of the entire study.
13) Use within 2 weeks prior to baseline of: 1) abradants, facials, peels containing glycolic or other acids, masks; 2) washes or soaps containing benzoyl peroxide, salicylic acid, or Sulfacetamide sodium; 3) non-mild facial cleansers; 4) moisturizers that contained retinol, salicylic acid or α-or β-hydroxy acids.
14) Concomitant use/planned to use of mega-doses of certain vitamins (such as mega-doses of vitamin D [ >2000 IU/day], vitamin B6 [ >2 mg] or vitamin B12 [ >1 mg/day]), haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
15) Use of tanning booths or tanning lamps or excessive/prolonged exposure to the sun within 1 week prior to baseline and an unwillingness to refrain from use during the study.
16) With significant medical history of or are curren
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method