ACNE
Safety and Preliminary Efficacy of Combination Therapy for the Treatment of Acne Vulgaris
Acne vulgaris is a multifactorial, highly prevalent dermatologic
condition that results in visible lesions that can be quite
disfiguring. Consequently, individuals with acne often suffer
from a wide range of psychological manifestations. Although
there is consensus that combination therapy is most effective
in treating acne, researchers are constantly striving to develop
new treatment.
Microcurrent therapy (MCT) is a non-invasive modality that
has successfully been used to promote wound healing and has
been routinely used in aesthetics. Use of MCT alone or in combination
with current successful treatment such as blue light
phototherapy (BLP), may hold promise for acne treatment.
The investigators propose to conduct a small randomized control
trial to determine the safety and preliminary efficacy of a
novel combination therapy to treat acne vulgaris. The investigators
will recruit up to 60 males and females and randomly
assign them to one of 3 arms: 1) BLP; 2) MCT; and 3) combination
therapy (BLP and MCT). The investigators will assess
physiological parameters (number of acne lesions, amount of
sebum produced, degree of acne severity) and psychosocial
factors (dermatologic quality of life, social anxiety, depressive
symptomatology, self-esteem).
Participants will complete a baseline assessment prior to
initiating treatment and a follow-up assessment at 4 weeks
post termination of treatment. The investigators will conduct
intermediary assessments at weeks 3 and 5, and 1 week posttermination
of the treatment.
Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel and Risk of Formation of Atrophic Acne Scars
This is a multi-center, randomized, investigator blinded, vehicle
controlled trial using intra-individual comparison (right
half-face vs left half-face). Subjects will have each half-face
randomized to one of the two following treatments: adapalene
0.3% - benzoyl peroxide (BPO) 2.5% gel (TactuPump® Forte) or
vehicle gel.
The main objective of this trial is to evaluate the effect of
adapalene 0.3% - BPO 2.5% gel vs vehicle gel on the risk of
formation of atrophic acne scars in moderate to severe acne
subjects. The estimated enrollment is 60 patients, with clinical
diagnosis of moderate to severe acne vulgaris on the
face defined by 1) an Investigator’s Global Assessment score
of 3 or 4, with the same score on both sides; 2) a minimum
of 25 inflammatory lesions (papules and pustules) in total, with
at least 10 on each side (excluding the nose); 3) no more than
two acne nodules (≥ 1 cm); and 4) a minimum of 10 atrophic
acne scars in total (upper than 2 mm) (excluding the nose).
