A randomized, placebo-controlled, single-blinded, split-faced clinical trial evaluating the efficacy and safety of KLOX-001 gel formulation with KLOX light-emitting diode light on facial rejuvenation

Figures & data

Table 1 Study inclusion and exclusion criteria

Inclusion criteria
1.	Female
2.	30–65 years of age
3.	Caucasian
4.	Fitzpatrick skin type >Class II
5.	Willingness to undergo two biopsies in the retroauricular region
6.	Willingness to return for postoperative visits
Exclusion criteria
1.	Facial cosmetic procedure in the last 6 months
2.	Neuromodulator treatments within last 6 months
3.	Injectable fillers within last 12 months
4.	Poly-L-lactic acid injections within last 3 years
5.	Laser therapy within last 6 months
6.	Physical or psychiatric condition preventing the patient from completing the study
7.	Use of medications that would predispose to bleeding/bruising
8.	Use of drugs known to increase photosensitivity
9.	Isotretinoin use within last 12 months
10.	Cortisone use within last 6 months
11.	Pregnant or breast-feeding
12.	Marked facial asymmetry
13.	Active infection
14.	History of hypertrophic scarring
15.	History of radiation therapy to head or neck
16.	Dermatological comorbid disease
17.	Immunosuppression
18.	History of neuromuscular disorder
19.	Concurrent enrollment in similar study
20.	Prior surgery altering subcutaneous anatomy in the treated areas

Table 2 Summary of subject disposition during the study period

	Group A KLOX-001 gelformulation	Group B KLOX LED light	Group C KLOX-001 gel formulation + KLOX LED light	Group D Standard treatment	All subjects
	n=8	n=8	n=8	n=8	n=32
	n	n	n	n	n	%
Screened	–	–	–	–	32	100.0
Randomized	8	8	8	8	32	100.0
Completed	8	8	8	6	30	93.8
Discontinued	0	0	0	2	2	6.2
Termination reason
Lost to follow-up at week 12	0	0	0	2	2	5

Abbreviation: LED, light-emitting diode.

Figure 1 Improvement of crow’s feet and decrease in fine rhytides in the identified regions.

Figure 2 Improvement of crow’s feet and decrease in fine rhytides in the identified lower lid region.

Figure 3 Improvement of crow’s feet and decrease in fine rhytides in the identified regions.

Figure 4 Glabella improvement at week 12 (anterior view) in the identified region.

Table 3 Physicians’ assessment results

	Group A KLOX-001 gel formulation	Group B KLOX LED light	Group C KLOX-001 gel formulation + KLOX LED light	Group D Standard treatment	P-value
	n	n	n	n
Brow position
Treatment favored	–	1	5	–
No difference	24	23	19	18	0.001
Perioral wrinkling
Treatment favored	–	–	2	–
No difference	24	24	22	18	0.001

Notes: P-value based on chi-squared statistic comparing KLOX LED Light + KLOX-001 gel formulation (Group C) to all other groups. “Treatment favored” implies improved clinical brow position and perioral wrinkling (less perioral rhytides).

Abbreviation: LED, light-emitting diode.

Figure 5 Graphical representation of TWS placebo least-square mean adjusted predicted value change.

Abbreviations: LED, light-emitting diode; TWS, total wrinkle score; LS, least-square.

Figure 6 TWS placebo least-square mean adjusted predicted value change.

Abbreviations: LED, light-emitting diode; TWS, total wrinkle score; SD, standard deviation.

Figure 7 Gomori staining of retroauricular biopsy samples: (A) week 0; (B) week 12.

Notes: A visual increase of the amount of collagen (colored in blue with Gomori trichrome) was still visible 12 weeks after the first treatment, with apparition of dense and thick fascicles in the papillary dermis.

Table 4 Skin biopsy results (collagen in Gomori Trichrome staining)

Group A KLOX-001 gel formulation + sham light			Group B Sham gel + KLOX LED light			Group C KLOX-001 gel formulation + KLOX LED light			Group D Standard treatment
ID #	Week 0	Week 12	ID #	Week 0	Week 12	ID #	Week 0	Week 12	ID #	Week 0	Week 12
100	0.5	2	106	0	0	102	0	3	103	1	0
101	1	2	107	0.5	2	104	0	1	108	0.5	3
105	0.5	3	110	1	2.5	114	0.5	1.5	118	0.5	3
109	0	2	112	1	2.5	116	0.5	1.5	120	2	2.5
111	0.5	1	122	0.5	3	121	1	0	125	0.5	3
115	1	3	123	0.5	1.5	124	0	3	131	0	1.5
117	0.5	1.5	126	0.5	3	127	1	3
128	3	3	129	0.5	3	130	0	2
Av.	0.875	2.188	Av.	0.563	2.188	Av.	0.375	1.875	Av.	0.750	2.167
Change from week 0		+150%	Change from week 0		+287%	Change from week 0		+400%	Change from week 0		+189%

Note: Mean score at week 0 (baseline) and at week 12 for each treatment group was calculated, allowing the determination of the percentage of change from week 0.

Abbreviation: LED, light-emitting diode; ID, identification; Av., average.

Table 5 Summary of treatment-related adverse events

	Group A KLOX-001 gel formulation	Group B KLOX LED light	Group C KLOX-001 gel formulation + KLOX LED light	Group D Standard treatment	All subjects
	n=8	n=8	n=8	n=8	n=32
	n (%)	n (%)	n (%)	n (%)	n (%)
Total numbers and percentages of subjects with TEAEs	5 (63)	2 (25)	6 (75)	4 (50)	17 (53)
Erythema	3 (38)	1 (13)	0 (0)	2 (25)	6 (19)
Brow edema	1 (13)	1 (13)	2 (25)	0 (0)	4 (13)
Eye lid edema	2 (25)	0 (0)	1 (13)	0 (0)	3 (9)

Abbreviation: LED, light-emitting diode; TEAEs, treatment emergent adverse events.

Figure 8 Pore size improvement at week 12.