The use of topical retinoids is a mainstay and basis of early acne treatment to prevent the
progression to inflammatory lesions. Post oral isotretinoin, it is not uncommon for
non-inflammatory papules and comedones to recur. However, there has been no formal study to
look at the prevention of recurrence of these acne lesions post isotretinoin in a long term
basis. This may enhance the therapeutic options for post isotretinoin patients in order to
prevent recurrence of their disease.
Hypothesis Tretinoin microsphere 0. 04% will prevent recurrence of acne lesions.
Inclusion Criteria:
Subjects must fulfill all of the following criteria to be eligible for study admission:
- Males aged between 18 and 45 years old who have successfully completed a treatment of
acne with oral isotretinoin (Min 4 months/Maximum 6 months with an average of 5
months and a total of 120-150mg/kg/course).
- Who can attend scheduled study follow-up visits at the outpatient dermatology clinic.
- Agree to informed consent for participation in a study.
- Agree to comply with the treatment and follow up procedures.
Exclusion Criteria:
- Patients who receive isotretinoin for condition other than acne vulgaris.
- Patients who have been off isotretinoin for less than 30 days or more than 90 days at
the time of enrollment of the study.
- Patients who have used prescription topical acne treatment (tretinoin, benzoyl
peroxide, topical antibiotics or any combination products) between the end of therapy
of isotretinoin within 2 weeks of study enrollment or oral antibiotics of any type
between the end of therapy of isotretinoin within 4 weeks of study enrollment and
throughout the study.
- Patients who have been previously diagnosed with an endocrinological disorder likely
to cause acne such as genital/adrenal hyperplasia, adrenal tumors or any other hypo
androgenetic state.
- Patients who are using any of the systemic medications likely to cause or abate acne
such as oral Dilantin or any other epileptic, Finasteride, Spironolactone or
Flutamine, testosterone or dietary body-building protein powders.
- Have any nodulo-cystic lesions at baseline.
- Used topical corticosteroids on the face or systemic corticosteroids within the past
4 weeks. Use of inhaled, intra-articular, or intra-lesional steroids other than for
facial acne is acceptable.
- Are currently using any medication that in the opinion of the investigator may affect
the action or evaluation of the study product or place the subject at undue risk.
- Used abradants, facials, peels containing glycolic or other acids; masks, washes, or
soaps containing BPO, salicylic acid, or sulfacetamide sodium; non-mild facial
cleansers; moisturizers that contain retinol, salicylic acid, or α- or β-hydroxy
acids within the past 2 weeks.
- Plan to use medications that are reported to exacerbate acne (e. g., mega-doses of
certain vitamins, such as vitamin D [> 2000 IU per day] and vitamin B12 [> 1 mg/day],
haloperidol, halogens [e. g., iodide and bromide], lithium, hydantoin, and
phenobarbital), because these may impact efficacy assessments. Subjects who plan to
use multivitamins, iron supplements and folate are acceptable.
- Had a facial procedure (such as chemical or laser peel, microdermabrasion, blue light
treatment, etc) performed by an esthetician, beautician, physician, nurse, or other
practitioner, within the past 4 weeks or if it is planned to be performed during the
conduct of the study.
- Have a known hypersensitivity or have had previous allergic reaction to any of the
active components or excipients of the study product.
- Used any investigational therapy within the past 4 weeks, or currently participating
in another clinical study.
- Are currently abusing drugs or alcohol (drug screening not required).
- Have a significant medical history of being immunocompromised.
- Have other conditions that, in the judgment of the investigator, would put the
subject at unacceptable risk for participation in the study.
- Had any major illness within 30 days before the screening examination.
- Currently are employees of R Vender, an investigator, or contract research
organization (CRO) involved in the study, or an immediate family member (partner,
offspring, parents, siblings or sibling's offspring) of an employee involved in the
study.
