The U.S. Food and Drug Administration Tuesday issued a green light for the first dermal filler treatment that effectively reduces scars caused by acne, the most common skin disease in the country.

Acne affects millions of people in the U.S. and about 95 percent of these people can potentially suffer from acne scars. While there are several treatment options ranging from topical gels to lasers, nothing so far has been proven to satisfactorily treat scarring.

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Now, the FDA has declared "Bellafill", the dermal filler developed by privately held Suneva Medical Inc., as safe and effective in correcting moderate to severe, atrophic, distensible facial acne scars in patients at the age of 21 years and above.

Bellafill consists of 80 percent purified bovine collagen and 20 percent polymethylmethacrylate microspheres. It works by increasing the volume on the skin of patients and lifts and smoothes out acne scars to the level of the surrounding skin.

The approval was based on the results of a randomized placebo-controlled study where patients with acne scars were treated with Bellafill and a control saline injection at 10 clinical centers in the U.S for six months.

After six months, about 64 percent of the patients treated with Bellafill improved by two or more points on a 4-point Acne Scar Rating Scale compared to only 33 percent of patients who were treated with injection.

Bellafill further showed effectiveness by an unblinded assessment at 12 months where almost 71 percent of the patients gained improvement.

The outcome of the clinical study only proves Bellafill reduces the appearance of acne scars, noted Suneva Medical CEO Nicholas L. Teti, Jr.

Teti added that Bellafill provides a solution to the widespread skin condition that previously limited treatment options. Bellafill can also have a transformational effect on a patient's appearance, which can give hope a person will improve his quality of life.

TagsAcne, Food and Drug Administration, Bellafill