Home » Drug Information » Recently Approved Drugs » 1996
Medical Areas: Dermatology/Plastic Surgery
Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Galderma Laboratories
Approval Status: Approved June 1996
Treatment Area: acne
Differin Gel 0.1% has been approved for the treatment of acne.
Differin Gel is a new topical prescription medication that
penetrates deeply into hair follicles where it can prevent and
reduce blackheads and whiteheads.
In controlled clinical trials, Differin Gel was shown to
effectively reduce the number and severity of acne lesions after 12
weeks of therapy. Furthermore, the subjects on Differin Gel
experienced less skin dryness and skin irritation than those on
topical Tretinoin Gel 0.025%. Stinging, burning, peeling, and skin
redness associated with retinoid therapy have been a barrier to
subjects remaining on their Tretinoin acne medication and achieving
successful treatment outcomes.
Some adverse effects such as erythema, scaling, dryness,
pruritus, and burning will occur in 10%-40% of subjects. Pruritus
or burning immediately after application also occurs in
approximately 20% of subjects. The following additional adverse
experiences were reported in approximately 1% or less of subjects:
skin irritation, burning/stinging, erythema, sunburn, and acne
flares. These are most commonly seen during the first month of
therapy and decrease in frequency and severity thereafter.
Differin Gel is a synthetic retinoid analogue with advanced
receptor selective activity and potent anti-inflammatory and
comedolytic properties.
Shalita, Weiss, Chalker, et al. "A comparison of the
efficacy and safety of adapalene gel 0.1% and tretinoin gel 0.025%
in the treatment of acne and vulgaris: A multicentre trial."
Journal of the American Academy of Dermatology. March,
1996.