Health TrialsbyHealthPanel

Secretome TGF Beta 3

ConditionMelasma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-60
SponsorIndonesia University

About this trial

A therapeutic modality currently being developed for melasma is secretome. Secretome is a bioactive molecule secreted by mesenchymal stem cells in a conditioned medium containing a large number of growth factors, cytokines, various macromolecules, and extracellular vesicles, including microvesicles and exosomes, that can stimulate various biological reactions, particularly in modulating new tissue formation. Secretome can provide a depigmenting effect by increasing the proliferation and migration of epidermal keratinocytes, which contain melanin pigment, in line with increased fibroblast synthesis.

Secretomes contain various cytokines and growth factors, one of which is transforming growth factor (TGF)-β. TGF-β is primarily secreted by fibroblasts (FB) and, to a lesser extent, by keratinocytes, and plays a crucial role in regulating melanocyte function. TGF-β has been reported to inhibit cAMP/protein kinase A signaling and induce GLI2, which then suppresses microphthalmia-associated transcription factor (MITF), a central transcription factor in melanogenesis. A study by Moon et al. in Korea examined TGF-β3. Moon et al. examined the effects of TGF-β3 on melanogenesis in human melanocytes co-cultured with skin cells irradiated with ultraviolet (UV) light, and in UV-irradiated human skin. The results showed that UVB irradiation or stem cell factor (SCF)/endothelin-1 (ET-1) increased melanogenesis. TGF-β3 effectively inhibited melanin accumulation and tyrosinase activity by downregulating the extracellular signal-regulated kinase (ERK)/microphthalmia-associated transcription factor (MITF) pathway. TGF-β3 increased the expression of keratinocyte differentiation markers.

Mechanistically, TGF-β3 inhibits melanogenesis by inhibiting MITF expression, which is regulated by ERK. TGF-β1 reduces MITF but at the risk of inducing skin fibrosis. However, in the study by Moon et al., the aforementioned TGF Beta 1 function was not found in TGF-β3. Furthermore, TGF-β3 restored skin differentiation function in UV-irradiated keratinocytes.

To date, there have been no clinical trials comparing intradermal injection of concentrated secretome with intradermal injection of concentrated secretome with the addition of TGF-β3 as a melasma therapy in Indonesia, thus encouraging researchers to conduct further research.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women diagnosed with melasma.

Women without melasma and have areas of skin that are clinically free of lesions for SP control.

30-60 years old.

Fitzpatrick skin type IV-V.

Disqualifiers

Pregnant and breastfeeding women.

Currently using hormonal contraception or have ever used contraception hormones in the last 6 months.

Using topical therapy for melasma, for example corticosteroids, tretinoin, hydroquinone, and other therapies that whiten or brighten the skin in the last 2 weeks.

Using topical triple combination cream therapy for at least 3 months and did not show significant improvement

Trial design

Design model

Parallel

Treatments tested in this trial

  • Concentrated secretome Injection 3 mL

    Drug

    The secretome used in this research comes from mesenchymal stem cells from adipose tissue produced by Dr. Cipto Mangunkusumo Hospital Stem Cell Medical Technology. The secretome produced by mesenchymal stem cells is collected, centrifuged to separate it from debris, and followed by filtration with a 0.22 μm pore filter to ensure sterility. Next, the concentration process is carried out using tangential flow filtration with the Spin-X UF 500® concentrator, packaged, and stored at -80 degrees Celsius. The product used is a sterile product, which is tested for sterility and total protein content. When it is to be used, the secretome is removed from the freezer, warmed (thawing), and injected into the patient according to a predetermined method.

  • Concentrated secretome Injection 3 mL with addition of TGF Beta 3

    Drug

    The secretome used in this research comes from mesenchymal stem cells from adipose tissue produced by Dr. Cipto Mangunkusumo Hospital Stem Cell Medical Technology. The secretome produced by mesenchymal stem cells is collected, centrifuged to separate it from debris, and followed by filtration with a 0.22 μm pore filter to ensure sterility. Next, the concentration process is carried out using tangential flow filtration with the Spin-X UF 500® concentrator, packaged, and stored at -80 degrees Celsius. The product used is a sterile product, which is tested for sterility and total protein content. When it is to be used, the secretome is removed from the freezer, warmed (thawing), and injected into the patient according to a predetermined method after the secretome is ready, TGF beta 3 will be added to secretome

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: Secretome raw material groupExperimental treatment 2 interventions
Group B: Secretome raw material with addition of TGF Beta 3 groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change of Melasma Severity based on Patient's Tolerability Assesment (PtGA).

one method of evaluating the response to therapy in melasma which is assessed subjectively by the patient. The response to therapy can be assessed as follows No or slight response: \< 25% improvement Moderate response: 25% - 50% improvement Good response: 50% improvement - \< 75% Excellent response: improvement \> 75% The response is said to be good if the score is above 50% since the previous visit

Time frame
re-evaluation on day 14, 28, 42, 56 and day 84 of therapy
2

Change of Melasma Severity based on modified Melasma Severity Index (mMASI) score

The range of values for mMASI is between 0 and 24 which can then be divided into mild melasma (0-8), moderate (8-16), and severe (16-24). improvement occurs if the mMASI score decreases by \<50% from the previous visit worsening if score persists or mMASI Score Increase \>50% re-evaluation on day 14, 28, 42, 56 and day 84 of therapy

Time frame
re-evaluation on day 14, 28, 42, 56 and day 84 of therapy
3

Change of Melasma Severity based on Dermoscopy

based on Dermoscopy Telangiectasis score assessment using a 5-point dermoscopy-scale: 0 = No visible capillaries. 1 = Elongated capillaries accompanied by dilation, not visible to the naked eye. 2 = Moderate telangiectasis that is beginning to be visible to the naked eye. 3 = Severe telangiectasis characterized by reduced capillary loops. 4 = Very severe telangiectasis characterized by dilatation and loss of capillary loops.

Time frame
re-evaluation on day 84 of therapy
4

Change of Melasma Severity based on Wood's Lamp

Epidermal Type/ Dermal Typed/ Mixed Typed

Time frame
re-evaluation on day 84 of therapy

Secondary outcomes

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Dr. Cipto Mangunkusumo Hospital Status unavailable 10430, Central Jakarta, D.k.i JakartaIndonesiaIndonesia

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indonesia University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: