Imedeen Derma One

Imedeen Derma One, previously known as Imedeen Classic, is an evolution of the original formulation that has been tested multiple times over the past 20+ years for its beneficial effects on photoaged skin.

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Effects


Grade Level of Evidence
A Double-blind, controlled study with more than 50 participants.
B Controlled study that is single-blind or has less than 50 participants.
C Controlled or comparative study.
D Uncontrolled or observational study.
Grade Effect Size of Effect Comments

C

Increased skin thickness

Strong

Results in large increases in epidermal and dermal thicknesses because it reactivates epidermal proliferation and stimulates the synthesis and deposition of dermal collagen.

C

Increased skin hydration

Moderate

Reduces skin dryness, probably due to an improved skin barrier that leads to less evaporative water loss.

C

Wrinkle treatment

Mild

May improve crow's feet and fine lines, and reduce the number of wrinkles overall.

C

Tighter skin

Mild

Improves skin laxity, but to a smaller extent than supplementation with Vivida.

D

Increased skin elasticity

Moderate

3 months of daily supplementation leads to a 10-30% improvement in skin elasticity.

D

Skin lightening

Mild

Appears to reduce brown mottling of the skin and to improve skin coloration.

D

Increased hair growth

Mild

500mg of Imedeen daily for 3 months led to hair growth on the upper legs in one woman and regrowth of scalp hair in a bald man in one study.

D

Smoother skin

Mild

May improve skin smoothness

D

Enhanced barrier function

Mild

May improve the skin barrier, since it decreases transepidermal water loss (TEWL).

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Ingredients


Marine Complex, Zinc, Ascorbic Acid
NAME ANTIOXIDANT UV PROTECTION COMEDOGENIC IRRITANT SAFETY
MARINE COMPLEX NO RECORDS FOUND
ZINC (ANTIOXIDANT) NO DATA NO DATA ALLOWED (SOURCE)
ASCORBIC ACID (ANTIOXIDANT, BUFFERING, MASKING, SKIN CONDITIONING) NO DATA NO DATA ALLOWED (SOURCE)

Clinical Studies


Study of Imedeen in the regulation of epidermal water and oil content by human experiments.

Products

Imedeen

Trial Design

Randomized, placebo-controlled

Duration

45 days of treatment

Subjects

62 Chinese men and women aged 18-40 years

Regimen

Half of the subjects were randomly allocated to the placebo group while the other half were in the active group. Subjects in both groups took the Imedeen / placebo tablets twice daily, one tablet each time.

Methods of Assessment

Measurements of the skin's water content, oil content, and pH value using the Skin Analyzer SHP 88.

Side Effects

Participants observed no changes in their general condition including appetite, sleep cycles, metabolism or mental health. No adverse effects were seen in the routine blood, urine and biochemistry tests.

Conflicts of Interest

None declared.

Effects observed in this study:

The mean water content of the skin of the participants in the active (Imedeen) group was enhanced after treatment, and there was a statistically significant difference compared to the placebo group. The mean oil content of the skin of the active group's participants was also significantly increased compared to baseline, but the difference between the active and placebo group did not reach statistical significance. Skin pH did not appear to be significantly affected in either group.

Imedeen in the treatment of photoaged skin: an efficacy and safety trial over 12 months.

Products

Imedeen

Trial Design

Randomized, double-blind and placebo-controlled for the first 3 months, with an open and uncontrolled 9-month continuation.

Duration

12 months of treatment

Subjects

144 Caucasian individuals ranging from 35-50 years, of Fitzpatrick phototypes II or III and mild to moderate facial photoaging. 140 subjects completed the 3-month trial, of which 111 went on to complete the additional 9-month continuation.

Regimen

In the initial trial, participants took either 358 or 258 mg of Imedeen daily, or a placebo. For the 9-month continuation, 2 additional groups were formed from the original placebo group, who had daily intakes of 258 mg and 207 mg of commercial Imedeen tablets. The subjects continued with their usual skin care routine during the study.

Methods of Assessment

Investigator assessments of the degree of fine wrinkling in the crow's feet area and the overall photoaging of the face using a visual analogue scale.

Self-evaluations by the subjects on their overall skin condition, also using the visual analogue scale.

Assessments of fine wrinkles, overall photoaging, telangiectasis, hyperpigmentation and coarse wrinkles using color photographs of the subjects' faces, including close-ups of the crow's feet area, by a panel of 3 dermatologists. Improvements were scored on a 7-point scale in the double-blind trial and on a simplified 3-point scale for the continuation. Photographs taken at the end of each part were also compared with the baseline photographs.

Measurements of skin thickness and density using a Dermascan C scanner.

Measurement of transepidermal water loss (TEWL) using an Evaporimeter EP IC.

3D skin surface analysis of silicone imprints taken from each subject using an optical prolifometer.

Side Effects

63 subjects reported a total of 154 adverse events during the study. 118 were mild, 35 moderate and one event was severe, but not related to Imedeen. 58 out of the remaining 117 adverse events were considered probably related to the study. The majority of the skin-related events were of acne and seborrhoea, while edema and weight gain were the most frequently non-skin-related events reported. 11 subjects withdrew from the study due to the adverse events. However, routine blood and urine chemistry did not identify any pathological changes.

Conflicts of Interest

Study was sponsored by Ferrosan A/S. One of the authors was a consultant to the company, and the other was an employee.

Effects observed in this study:

After the 3-month study, pre-defined analyses showed no significant results in any of the variables studied. However, exploratory statistical analyses found an increase in the ultrasound density of the dermis and a decrease in fine lines measured by optical prolifometry, in the high dose (358 mg daily) group, after correlation for baseline age and sun exposure.

Following the additional 9 months of continuation, there were no significant differences in efficacy between the 4 treatment groups, so the data was pooled and compared to baseline. This revealed a significant improvement in the investigator's assessment of fine lines in the crow's feet area and in the assessment of overall facial photoaging. Similarly, a significant improvement was seen in the volunteers' self-assessments of skin condition. The dermatologists' evaluations of the photographs also demonstrated significant improvement in fine lines, telangiectasis, hyperpigmentation and overall photoaging. Measurements of the silicone replicas indicated an improvement in skin smoothness.

There was also a steady and significant increase in the ultrasound measurements of the density of the papillary and reticular dermis. Further, there were significant declines in the transepidermal water loss (TEWL) from both sun-exposed and unexposed skin.

Psychosocial effects of skin treatment with Imedeen.

Products

Imedeen

Trial Design

Randomized, double-blind, placebo-controlled

Duration

3 months

Subjects

45 Caucasian women with normal skin condition relative to their ages.

Regimen

Subjects took 1 tablet of Imedeen (415 mg) twice daily.

Methods of Assessment

Social anxiety, social skills, self-esteem, satisfaction with several parts of the body, state and trait anxiety, and psychological and social problems related to the skin were measured through questionnaires.

Side Effects

Unknown

Effects observed in this study:

Imedeen supplementation did not have any significant effect on any of the measured psychosocial variables.

An oral approach to the treatment of photodamaged skin: a pilot study.

Products

Imedeen

Trial Design

Uncontrolled

Duration

90 days of treatment

Subjects

5 women and 1 man aged 26-53 years, who were of Fitzpatrick phototypes II or III and had moderately photodamaged skin.

Regimen

The patients took 0.5g Imedeen daily in the form of 2 tablets.

Methods of Assessment

Review of standardized photographs taken at baseline and on day 90, by the main investigator and an experienced cosmetologist.

Skin thickness was measured 2 cm laterally from the left eye using Dermascan A.

Skin elasticity was determined on the left cheek by a Dermaflex instrument.

Subjects' diaries of their personal impressions, as well as remarks made by others they came into contact with.

Side Effects

All volunteers noted an induction of recurrent pimples that were almost exclusively restricted to the face. Most experienced only a small number of pimples (1-3), but 2 volunteers recorded 6-15 pimples during the study. No scarring occurred.

Conflicts of Interest

None declared.

Effects observed in this study:

Photographs of 2 patients were not available for pre- and post-treatment evaluation. All of the remaining 4 patients who were assessed achieved noticeable decreases in superficial wrinkles around the eyes, as well as reductions in brown mottling and skin coloration. The overall improvement in the skin was rated as excellent in 1 patient, good in 1 patient and satisfactory in 2 patients.

All 6 volunteers also had increases in dermal thickness, with the average overall increase being 83%. Skin elasticity improved more modestly, with the elasticity index rising by an average of 10%.

A review of the diaries kept by the participants indicated that the overall impression of the volunteers was that of an improvement in the skin, with a smoother or softer feeling and a decrease in wrinkle number. Other people with whom the participants came into contact during the study also provided favorable subjective assessments.

In addition, 1 woman experienced some hair growth on the upper legs, whereas the man, who was bald, reported regrowth of the hair on his scalp. Some participants had the impression that their hair was stronger and less fine.

Natural cartilage polysaccharides for the treatment of sun-damaged skin in females: a double-blind comparison of Vivida and Imedeen.

Products

Imedeen

Vivida

Trial Design

Double-blind, randomized, comparative

Duration

90 days of treatment

Subjects

30 women aged 40-60 years

Regimen

15 women were randomly allocated to receive Vivida while the other 15 received Imedeen, to be taken orally on a daily basis.

Methods of Assessment

Clinical examinations were conducted at baseline and day 90, where physicians graded skin thinning, laxity, wrinkles, mottles, dryness plus the brittleness of the hair and skin on a 3-point scale.

The thicknesses of the epidermis and dermis were measured 2 cm laterally from the left eye using Dermascan C.

The elasticity index of the skin from the left cheek was measured using Dermaflex A.

Side Effects

5 subjects in the Vivida group developed transient, mild pimples during the first weeks of treatment. No other adverse effects occurred.

Conflicts of Interest

None declared.

Effects observed in this study:

At baseline, all patients had moderate to severe thinning of the facial skin, skin laxity, skin dryness and wrinkles. The majority also had moderate to severe mottles and brittle nails, and approximately half had fragile hair.

By the end of the study, all of the patients treated with Vivida had skin of normal thickness, and most had either no or moderate wrinkles as well as mottles. None had dry skin, loose skin, brittle hair or brittle nails. The patients in the Imedeen group witnessed definite but less dramatic improvements in skin thinning, laxity, wrinkles, dryness, mottles and the fragility of their hair and nails. The difference between the 2 treatment groups was statistically significant for all parameters.

The patients who had taken Vivida also saw larger increases in epidermal thickness (86% versus 38%), dermal thickness (68% versus 21%) and skin elasticity (51% versus 17%) compared to the patients who had taken Imedeen.

Since the daily dose of Vivida contained 500 mg of active polysaccharides while the daily dose of Imedeen had been reduced to 380 mg (compred to 500 mg in an earlier study), the effect of the polysaccharides appear to be dose-dependent.

Imedeen for the treatment of degenerated skin in females.

Products

Imedeen

Trial Design

First trial: open, uncontrolled

Second trial: double-blind, placebo-controlled

Duration

90 days of treatment for both trials.

Subjects

Pilot: 10 women aged 39-61 years and with moderately severe solar elastosis.

Double-blind study: 30 women aged 40-63 years and with definite solar elastosis.

Control group: Before the trials, 70 individuals aged 20-80 years were examined for skin thickness and elasticity.

All of the subjects, including those in the control group, were of Fitzpatrick phototype II or III.

Regimen

Pilot: The women took 0.5g of Imedeen daily.

Double-blind study: 15 women were randomly allocated to take 0.5g of Imedeen daily, and the remaining took 0.5g of placebo daily.

Methods of Assessment

Clinical records of wrinkles, dryness, mottles, solar keratosis and brittleness of the hair and skin.

Skin thickness was measured 2 cm laterally from the left eye.

Skin elasticity was determined from the left cheek using Dermascan A.

Side Effects

No adverse effects were observed.

Conflicts of Interest

The Imedeen tablets were provided by Ime-Enterprises. There were no other conflicts of interest.

Effects observed in this study:

Pilot study: After 90 days of treatment with Imedeen, improvements in wrinkles, mottles and skin dryness were observed, though the only woman with solar keratosis showed no improvement. All patients with brittle hair and nails showed normalization. The improvements in skin thickness and elasticity were confirmed by the instrumental measurements, which revealed a progressive augmentation throughout the duration of the treatment. By the end of the study, the average skin thickness had increased by nearly 70% and the average elasticity index had risen from 46% to 72%. These parameters were comparable to those of the untreated individuals aged 21-31 years in the control group.

Double-blind study: Following 90 days of treatment, the subjects in the Imedeen group had achieved similar improvements in the severity of their wrinkles, mottles, dry skin and in the brittleness of their hair and skin as in the pilot trial, but the subjects in the placebo group showed no improvement. Importantly, the difference between the Imedeen and placebo groups was statistically significant. Likewise, the mean skin thickness increased by almost 82%, reaching a level comparable to those in the 21-31 age range in the control group, and the elasticity index rose to 60% from 48%, reminiscent of those aged about 41 years in the control series.

Marine-derived nutrient improves epidermal and dermal structure and prolongs the life span of reconstructed human skin equivalents.

Products

Marine Complex of Imedeen

Results / Report

The Marine Complex stimulated the expression and deposition of type I collagen when added to cultures of human skin equivalents (HSEs). It also reactivated epidermal proliferation of "mature" HSEs, increasing the number of viable cell layers and improving epidermal morphology. Moreover, it did so without affecting cellular differentiation or inducing epidermal stress. Finally, it had a remarkable effect on the deposition of the basement membrane components laminin 332 and collagen type VII at the dermal-epidermal junction.

Most of the effects were more pronounced in female HSEs than in male HSEs.

Drug rash with eosinophilia and systemic symptoms (DRESS) attributed to the oral skin-care supplement Imedeen.

Products

Imedeen

Results / Report

A 56-year-old woman developed a drug rash with eosinophilia and systemic symptoms (DRESS) that was attributed to Imedeen. She recovered completely after nearly 4 months of treatment with corticosteriods and methotrexate.

Registration of suspected adverse effects by the Bureau Adverse Effects Drugs; research activities in 1993.

Products

Imedeen

Results / Report

The Netherlands Centre for Monitoring of Adverse Reactions to Drugs received a few reports of skin reactions to Imedeen in 1993.