- In controlled study, there was a statistically significant greater level of improvement in the global photoaging score on the hexyl aminolevulinate HCl (HAL) side compared to the placebo side
- Cosmetic HAL appeared to deliver cosmetic benefit of facial rejuvenation with little downtime
- Edema, erythema was higher on HAL-treated sides
A randomized, split-face, controlled study has shown that photodynamic treatment using hexyl aminolevulinate HCl (HAL; Allumera, PhotoCure) and multiple laser and light sources is safe, well tolerated and effective for photorejuvenation, says Sabrina Fabi, M.D.
The study enrolled 21 patients with moderate-to-severe photoaging, and all but one completed the trial that involved three treatment sessions and a final evaluation at one month after the last treatment. The enrolled patients had a mean age of 52 years, Fitzpatrick skin types II-IV and were nearly all women.
The cosmetic treatment protocol included pretreatment with microdermabrasion followed by acetone face wash. HAL or placebo cream was applied to one randomly selected side of the face, and the alternate cream was applied contralaterally and kept on without occlusion for one hour. The face was then washed and standard laser and light treatments delivered, beginning with a pulsed dye laser to treat telangiectasias and erythematous macules and papules, followed by intense pulsed light treatment to the entire face and then full-face concomitant red and blue light illumination.
STUDY RESULTS The primary efficacy endpoint was the investigator evaluation of global photodamage based on review of standardized photographs and using a 5-point scale to rate changes from baseline. The results favored the HAL-treated side numerically for providing greater benefit, but both treatments were associated with a 50 to 75 percent improvement overall, and the between-group difference was not statistically significant, Dr. Fabi says.
A patient before (left) and after three PDT sessions with hexyl aminolevulinate HCl. (Photos credit: Mitchel P. Goldman, M.D.)
There was a statistically significant greater level of improvement in the global photoaging score on the HAL-treated side versus the placebo side in assessments done just prior to the third treatment, and despite the similarities in final efficacy outcomes and tolerability, patient preference ratings interestingly showed that patients favored the HAL treated side, Dr. Fabi says. Five patients (25 percent) had no preference for one treatment versus the other, but among the 15 who did, the HAL-treated side was favored 2:1.
"Photodynamic therapy using 5-aminolevulinic acid and methyl aminolevulinic acid has been proven very effective for treating actinic keratoses and acne scarring. However, use of these therapeutic modalities for strictly cosmetic indications has been limited by treatment-related side effects, which include significant erythema, edema and irritation," says Dr. Fabi, who is in private practice at Goldman, Butterwick & Associates, Cosmetic Laser Dermatology, La Jolla, Calif.
"Our study found that photodynamic treatment using the new cosmetic HAL as the photosensitizer was very well-tolerated by patients seeking rejuvenation for photoaging and appears to deliver the cosmetic benefit that consumers are seeking without the unwanted side effects such as downtime," she says. "While the multiple laser and light sources used in this study were also very effective, there was more improvement earlier using HAL, and perhaps a benefit may also be found when using HAL with a single light or laser source for activation."
Changes in fine lines/wrinkles, hyperpigmentation, telangiectasia, erythema, tactile roughness and sallowness were also rated with a 5-point scale, and both treatments were associated with statistically significant improvements from baseline in ratings of the six individual signs of photoaging at study completion. Again, there were no statistically significant differences between them at the final assessment.
Assessments performed just prior to the second treatment visit showed both HAL photodynamic treatment and treatment with placebo cream were associated with statistically significant improvements in global photoaging, tactile roughness, sallowness and telangiectasia, while there were statistically significant improvements in fine lines/wrinkles, hyperpigmentation and erythema by the third treatment session, Dr. Fabi says.
SAFETY, TOLERABILITY Safety and tolerability were assessed by having patients rate the severity of post-treatment pain, erythema and edema immediately after treatment and daily for one week using a 6-point scale. After the first and second sessions, edema was significantly worse on the HAL-treated side, and there was significantly more erythema on the HAL side after the first session only. There were no treatment-related differences in pain rated immediately after any session or for any of the signs and symptoms during the week after the procedure, Dr. Fabi says.
Disclosures: The study was sponsored by a grant from PhotoCure. Dr. Fabi and her co-authors report no relevant financial interests.