The present study was carried out during the fall of 1999 in Norway. The purpose was to investigate the effect and tolerability of LEROSETT® involving the treatment of acne.

Beyond doubt, the product had a definite effect upon acne problems when compared to the placebo treatment. The tolerability of the treatment was excellent and all subjects completed the study according to the directions and each subject achieved clearer skin in varying degrees. NO SUBJECTS STAYED THE SAME OR GOT WORSE.

LEROSETT® can be a valuable remedy in over-the-counter (OTC) armamentarium remedies for the treatment of acne and oily skin.

Lillestrom, Norway
February 2000

Erling Thom, Ph.D

INTRODUCTION

Acne is a common dermatosis which has been reported to affect up to 85% of adolescents. The endogenous processes governing acne initiation, development and its spontaneous resolution, are not yet fully clarified. At present, increased sebaceous gland activity and abnormal follicular keratinization are considered to be the primary events leading to the manifestations of non-inflammatory, comedonal acne. Increased propagation and activity of the follicular "Propionibacterium acnes" and subsequent follicular/perifollicular inflammation processes elicited by bacterial metabolic products are considered to be the patogenetic factors leading to the development of the inflammatory stages of acne.

A number of products are available for the treatment of mild to moderate acne. Among all treatment substances, benzoyl peroxide, salicylic acid, sulfur and azelaic acid are the most frequently used. A number of other remedies are also available; however, none of these treatments are optimal. They have either a lack of effect or give a number of side effects- mainly dryness and/or redness of the skin. Most acne drugs cannot be applied to skin that is broken or open, this is a serious issue since acne often breaks through the surface of the skin.

Based on the above mentioned experiences, Gunilla of Sweden® decided to carry out a controlled study "one of several" in the treatment of acne and oily skin.

The present study was initiated to investigate the efficacy and tolerability of LEROSETT® in the treatment of acne and oily skin.

DESIGN OF THE STUDY

The study was carried out as a randomized, double-blind, placebo-controlled study with two parallel groups. Forty subjects, ages 18 to 30 years, of both genders with mild to moderate acne, according to Pillsbury, were recruited to the study. After having received verbal and written information about the study, the participants signed a consent form and were included in the study.

The study was carried out in accordance with the Declaration of Helsinki and Good Clinical Practice (GCP) and local regulations.

The participants were randomized to receive LEROSETT® or Placebo treatment by a simple block randomization procedure, using gender as a stratification factor.

The two products had similar appearances and cosmetic properties and were packed in similar tubes in order to meet the double-blind design.

The tubes contained 70 ml of either products. The participants were instructed how to use the ointment. The total observation period in the study was 6 weeks, and the products were used as follows:

Week 1: Use once every day. The LEROSETT® was applied for 15-20 minutes and then removed with warm water.

Weeks 2-6: LEROSETT® was used once every third day. The ointment was applied for 15-20 minutes and then removed with warm water.

A moisturizer was recommended as concomitant when needed.

PERFORMANCE OF THE STUDY

The participants were examined three times during the study initially and after three and six weeks.

Clinical examinations of the acne status were done on each occasion. In addition, the participants carried out self-evaluations of the acne status. On each occasion, the participants were asked if they had any adverse events with LEROSETT®, all subjects answered no.

VALIDITY OF LONG TERM PROFESSIONAL AND CLINICAL USE
Several skin care professionals with experience using LEROSETT® requested to have their statements made public.

It should be noted that LEROSETT® has been used to treat all levels of acne from Pillsbury level 1 to level 4 by thousands of skin care professionals since 1985. For the purpose of this study the opinions of licensed skin care professionals with a minimum of 10 years experience using LEROSETT® on acne patience should be noted.

I used many therapeutic products in my busy dermatological practice the "Oakland Acne Clinic and Ethnic Skin Treatment Center" in California. I cannot tell you how thrilled I am with the quality and action of LEROSETT®. I am particularly pleased with its oil absorption and exfoliating properties. In fact, it is becoming the favorite treatment for our paramedical staff.~ Oakland Acne Clinic and Ethnic Skin Treatment Center, Kathryn Leverette CMES and President.
Using LEROSETT® for over 20 years

Have to say - our spa uses very high standards when choosing skin care lines. We are very much a results-oriented spa and when we are deciding on products to bring on, we trial them extensively. We trial on clients that have the skin to tolerate it and would benefit. Naturally we trialed this (Lerosett) on several acneic clients (including myself) and WOW... we were super skeptical but I can't say how thrilled we are (how thrilled I am personally). There is nothing better than having full confidence in a product and knowing you're doing right by your clients. We are extremely proud to carry your line!
Thank you! Teshia Roy O'Keefe- New Face and Body Spa, Canton, MI

LEROSETT® clears and heals the skin, our estheticians have over 20 years of acne experience and LEROSETT® is the best product for my acne clients.~Josephine Latimer at Sunset Skin Care and Cosmetics, Oakland, CA and Houston, TX.
Using LEROSETT® to stop acne professionally for over 18 years

We specialize in the treatment of acne and LEROSETT® calms the skin and helps to prevent new acne breakouts. Our acne clients see results~You will not be disappointed!~Joanne Buckhold at The Acne and Skin Care Clinic, Folsom, CA
Using LEROSETT® to stop acne professionally for over 18 years

LEROSETT® is the only mask I carry and I consider LEROSETT® to be a MIRACLE MASK!~Cheryl Goodheim at The Works Skin Care Spa, Carlsbad, CA
Using LEROSETT® to stop acne professionally for over 17 years

LEROSETT® works like magic for acne, our clients are addicted to this truly remarkable product.~Irene Kelly at SPA du Soleil, Scottsdale, AZ
Using LEROSETT® to stop acne professionally for over 15 years

LEROSETT® is the most amazing acne product I have ever used in my 20 plus year career as a "esthetician" skin care professional. ~Lana Vinnik at L'Image Skin Care and Dermatology, Milwaukee, WI
Using LEROSETT® to stop acne professionally for over 12 years

STATISTICAL ANALYSIS

Assumed continuous variables were expressed by mean values and 95% confidence intervals. In addition to mean values, the location parameters were estimated by a median with 95% confidence intervals constructed by the Bermoulli-Wilcoxon procedure. The standard deviation and the total range were used as indices of distribution.

All testes, both inter- and intra- group, were carried out two- tailed with a significance level of 5%. Assumed continuously distributed variable were analyzed, using ANOVA models with repeated measurements, for both comparison between and within groups. SAS(version 6.0) software was used for all statistical analysis.

RESULTS

Forty subjects (20 females/20 males) were included in the study. Twenty subjects were randomized to LEROSETT® and 20 subjected to the Placebo treatment. The gender distribution, age, and severity of the acne and the duration of acne were not significantly different in the two groups. These parameters in the two groups at baseline are shown in table 1.

TABLE 1: COMPARISON OF THE TWO TREATMENT GROUPS AT BASELINE:

LEROSETT® GROUP

NUMBER: 20
GENDER: 10F/10M
AGE: 19.7
SEVERITY: PILLSBURY 1 or higher
DURATION: 2.1 YEARS

PLACEBO GROUP

NUMBER: 20

GENDER: 10F/10M
AGE: 20.3
SEVERITY: PILLSBURY 1 or higher
DURATION: 2.3 YEARS

As shown in Table 1, all participants were classified as having some of Grade Pillsbury 1 or higher. The duration of the acne problems was 2.1 and 2.3 years in the two groups, respectively. The table shows that the two groups were comparable at the start of the study.

The participants were an average of approximately 20 years. All the participants had tried several different products for their acne problems without satisfactory effect. All patients were rated according to Pillsbury, having acne problems Grade 1 or higher.

According to the clinical observations made (on the global evaluation of acne on a scale of the following grading) the results were as shown in Table 2.

TABLE 2: THE OVERALL TREATMENT RESULTS, AS JUDGED IN THE CLINICAL EXAMINATION AT THE END OF THE STUDY AT 3 APPLICATIONS PER WEEK, WERE:

CHANGE IN ACNE -3 Applications per week

LEROSETT® GROUP

Worse-0%
Unchanged-0%
Somewhat better-30%
Much better-45%
Completely recovered-25%



PLACEBO GROUP

Worse-35%
Unchanged-55%
Somewhat better-10%
Much better-0%
Completely recovered-0%

The number of papules was also counted during the treatment on the left, the right and the front part of the face, respectively. There was a significant reduction of papules on the face, from an average of 25 at the start of the treatment to much less than 5 at the end of the treatment period in the LEROSETT® group, but no significant reduction was seen in the Placebo group. This is in accordance with the subjective overall ratings of the therapeutic success given by Table 2.

The patients' self-evaluations of the therapy results are given in Table 3. As can be seen from this table, there is a clear improvement in the therapy results over time with LEROSETT®. At the end of the treatment period, all subjects in the LEROSETT® group can be classified as having had positive results from the treatment. 15 out of 20 (75%) can be classified as much better. It is worthwhile to mention that 3 subjects had completely recovered after a treatment period of 5 weeks at 3 applications per week. It is a clear example of clinical effect over time. The results in the Placebo group show that only 2 of the subjects felt that they had "some improvement".

The correlation between the rating of the treatment results made by the investigator and the patients is striking - as can be seen by comparing Tables 2 and 3.

The tolerability of the treatment was good and comparable in the two groups. None of the subjects reported any adverse events that made them stop the treatment. A moisturizer was recommended as concomitant treatment.

TABLE 3: SUBJECTS' SELF-EVALUATIONS OF THE THERAPY RESULTS IN THE LEROSETT® AND IN THE PLACEBO GROUP WERE AS FOLLOWS:

CHANGE IN ACNE-3 Applications per week

LEROSETT® GROUP Worse -0%
Unchanged-0%
Somewhat better-10%
Better-45%
Much better-30%
Completely recovered-15%

Daily use of LEROSETT® will significantly increase the success rates of this three applications per week study.

PLACEBO GROUP

Worse-40%
Unchanged-50%
Somewhat better - 10%
Better-0%
Much better-0%
Completely recovered-0%

CONCLUSION

The results from this study clearly indicate that LEROSETT® has a highly positive effect on the treatment of acne and oily skin over a period of 6 weeks even when used at a minimum of 3 applications per week. All acne test subjects significantly improved by using LEROSETT® and all test subjects considered LEROSETT® to be the most effective treatment they had ever used. Many participants stated that even if LEROSETT® was less effective than many acne drugs on the market they would still rather use LEROSETT® to avoid the negative long term side effects related to acne drugs.

Cost restrictions prevent clinical testing for Pilsbury acne 1 at one or two applications per day as well as Pilsbury acne II at one, two or three applications per day. As does testing for Pilsbury acne levels III or higher at one, two or three applications per day.

The results are highly significant and in favor of LEROSETT® as compared to the Placebo treatment. It might be noted that an observation period of 6 weeks is too short to give the treatment full credit. Normally, the effect of the topical treatment of acne with other topical agents is seen 4 to 6 weeks after the start of treatment. Our results show that with proper use all cases of acne will improve if not completely clear when used for a period of time that related to the degree of acne the individual has.

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